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PubMed2001

Defibrillation efficacy comparing a subcutaneous array electrode versus an "active can" implantable cardioverter defibrillator and a subcutaneous array electrode in addition to an "active can" implantable cardioverter defibrillator: results from active can versus array trials I and II.

INTRODUCTION: Placement of implantable cardioverter defibrillators (ICDs) has been simplified by using the shell of a pectorally implanted ICD as a defibrillation electrode in combination with an endocardial right ventricular defibrillation lead. However, a sufficiently low defibrillation threshold (DFT) cannot be obtained in a few patients. Therefore, alternative approaches were systematically tested in the Active Can versus Array Trial (ACAT). METHODS AND RESULTS: In the first of two prospective randomized studies, the DFT of a subcutaneous left dorsolateral array anode introduced from a pectoral incision was compared to that of a standard active can anode in 68 patients. Intraoperatively, the DFT was determined twice in each patient using either the active can or, in patients with a subcutaneous array lead, once with all three fingers and once omitting the middle finger of the array. The second prospective randomized study included 40 patients. DFT also was determined twice in each patient using an active can in a left pectoral position as anode alone and combined with a left dorsolateral array electrode with two fingers. In ACAT I, stored energy at DFT decreased from 13.1+/-7.7 J (active can) to 9.6+/-6.1 J (three-finger array lead) (P = 0.04), impedance decreased from 53+/-8 ohms to 40+/-6 ohms (P < 0.0001). Omitting the middle finger of the array lead, stored energy at DFT increased by 0.9 J (P = 0.47) and impedance by 2 ohm (P < 0.0001). In ACAT II, DFT and impedance using an active can device were significantly lower when a two-finger array lead was added that decreased stored energy at DFT from 10.1+/-5.2 J to 6.9+/-3.9 J (P = 0.001) and impedance from 56+/-5 1 to 42+/-5 l (P < 0.0001). CONCLUSION: In combination with a right ventricular defibrillation electrode, a left pectoral subcutaneous array lead improves defibrillation efficacy if used instead of, or in addition to, a left pectoral active can ICD device. Implantation of the array lead can be simplified by using two instead of three fingers, without a significant loss of defibrillation efficacy.

Adult↗

PubMed1989

Subcutaneous ketamine analgesia: postoperative analgesia using subcutaneous infusions of ketamine and morphine.

A series consisting of 32 women undergoing total abdominal hysterectomy received a standard narcotic-free anaesthetic. For the first 24 h postoperatively, eight were given the standard regimen of intramuscular morphine sulphate whilst the other three groups received continuous subcutaneous infusions of either morphine sulphate, ketamine hydrochloride or the two drugs combined. The amount of time they were pain free, the incidence of sleep and nausea, together with cardiovascular and respiratory changes were recorded. All three subcutaneous regimens produced significantly more pain-free readings than intramuscular morphine, but ketamine resulted in higher respiratory rates and less sleepiness. No patient reported psychomimetic side effects, but ketamine on its own produced feelings of malaise in three patients on the second postoperative day. Subcutaneous infusions provide better postoperative analgesia than intermittent intramuscular morphine. Ketamine on its own cannot be advocated, but combined with morphine it allows a single infusion rate to be used for all patients, decreasing the need for nursing and medical involvement.

Adult↗

PubMed1985

Prevention of postoperative deep vein thrombosis by a combination of subcutaneous heparin with subcutaneous dihydroergotamine or oral sulphinpyrazone.

In a randomized clinical trial the effect of subcutaneous heparin alone or in combination with dihydroergotamine or sulphinpyrazone in preventing postoperative deep vein thrombosis (DVT) was studied. Sodium heparin (5000 IU) was administered subcutaneously twice daily; dihydroergotamine (1/2 mg) was also administered subcutaneously twice daily, and sulphinpyrazone (400 mg) was administered orally or intravenously twice daily. Administration occurred for at least 7 days. The diagnosis DVT was made with the radiofibrinogen uptake test. 358 patients undergoing major elective abdominal surgery were allocated to three treatment groups: heparin alone (Hep), heparin + dihydroergotamine (DHE-Hep) and heparin + sulphinpyrazone (Sulph-Hep). The frequency of DVT was 14/114 in Hep, 10/115 in DHE-Hep and 20/114 in Sulph-Hep. These differences were not significant. After application of the "logistic regression" procedure of Cox (1) it turned out that the major risk factors for developing DVT were age, sex, weight, type of operation and presence of diabetes mellitus. Also a significant treatment influence was observed (p = 0.001). This treatment effect was most probably due to improvement in the DHE-Hep group. The results in the Sulph-Hep group were not significantly different from those in the Hep group. A risk index was formulated on the basis of the above mentioned risk factors by which the chance of occurrence of DVT during heparin prophylaxis in an individual patient could be predicted. Patients that should receive additional prophylactic treatment can be defined by using this risk index.

Adult↗

PubMed1996

Continuous infusion or subcutaneous injection of granulocyte-macrophage colony-stimulating factor: increased efficacy and reduced toxicity when given subcutaneously.

Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a haematopoietic growth factor with a wide variety of applications in the clinic. In early phase I studies the continuous intravenous (c.i.) route of administration was often used. Later it was shown that subcutaneous (s.c.) administration was also effective. The optimal route of administration remains, however, poorly defined, and no studies have made a direct comparison between these two routes of administration. We treated patients with advanced breast cancer with moderately high-dose doxorubicin and cylophosphamide and GM-CSF. The first 14 patients received GM-CSF by c.i, while subsequently 47 patients received it s.c. Comparison between the two groups showed that c.i. GM-CSF was more toxic in several respects. There was a higher need for erythrocyte and platelet transfusions and a significant deterioration in the performance status. This study indicates that subcutaneous GM-CSF is the preferred route of administration. Randomised trials are, however, needed to confirm these conclusions.

Adult↗

PubMedDate not supplied

Aspiration of the subcutaneous insulin injection: clinical evaluation of needle size and amount of subcutaneous fat.

Investigating the rationale for a particular technique can reveal the surprising finding that some techniques are not based on scientific research. Aspiration of the insulin syringe is an example of a technique that evolved based on assumption. In a study designed to challenge the need to aspirate during insulin administration, 204 injections that were aspirated yielded no blood return. The historical and research literature supports the finding that aspiration never was proven to be a reliable indicator of correct subcutaneous needle placement. Because inadvertent intramuscular injection of insulin has been documented, diabetes educators need a reliable method to individualize insulin administration techniques to decrease the risk of incorrect needle placement. Until a reliable method is available, the literature supports lifting a skinfold for all subcutaneous insulin injections.

Adipose Tissue↗

PubMed1983

The pharmacokinetics of insulin after continuous subcutaneous infusion or bolus subcutaneous injection in diabetic patients.

Pharmacokinetic models of insulin were examined in order to describe a plasma concentration-time profile after subcutaneous (s.c.) administration of insulin to the patients with insulin-dependent diabetes mellitus (IDDM) or non-insulin-dependent diabetes mellitus (NIDDM). Diabetic subjects were restricted to those with fasting plasma insulin levels around the lowest limit for insulin assay (5 microU/ml). A one-compartment open model with first-order absorption and elimination was appropriate for estimating the plasma concentration-time profile of insulin injected or infused subcutaneously. In the case of continuous s.c. insulin infusion (CSII) for 1 h at the rate of 3 ml/h (2--3 U/ml), the absorption rate constant (Ka), elimination rate constant (Ke), and distribution volume (Vd) were 0.026 +/- 0.001 min-1 (mean +/- SEM; absorption half-life: 27 min), 0.013 +/- 0.005 min-1 (elimination half-life: 53 min), and 1.99 +/- 0.49 L/kg body wt, respectively. These values did not differ significantly from those generated by single bolus s.c. injection of undiluted insulin (40 U/ml). The calculated areas under the plasma insulin concentration-time curves from time zero to infinity ([AUC] 0 infinity) did not differ after each mode of administration, while the [AUC] 0 infinity after CSII was about 32% of that following intravenous bolus injection (P less than 0.01). The following conclusions can be drawn from these results: (1) the plasma concentration-time profile of insulin after CSII or bolus s.c. injection can be analyzed by pharmacokinetic modeling, (2) the absorption kinetics of insulin did ot differ significantly between two modes of s.c. insulin administration in the patients with IDDM or NIDDM, and (3) the insulin after CSII or single bolus s.c. injection seems to be degraded at the s.c. site to the same extent.

Adult↗

PubMed2000

Pharmacokinetics and pharmacodynamics of subcutaneous injection of long-acting human insulin analog glargine, NPH insulin, and ultralente human insulin and continuous subcutaneous infusion of insulin lispro.

To compare the pharmacokinetics/dynamics of the long-acting insulin analog glargine with NPH, ultralente, and continuous subcutaneous (SC) infusion of insulin lispro (continuous subcutaneous insulin infusion [CSII]), 20 C-peptide-negative type 1 diabetic patients were studied on four occasions during an isoglycemic 24-h clamp. Patients received SC injection of either 0.3 U/kg glargine or NPH insulin (random sequence, crossover design). On two subsequent occasions, they received either an SC injection of ultralente (0.3 U/kg) or CSII (0.3 U x kg(-1) x 24 h(-1)) (random sequence, crossover design). After SC insulin injection or CSII, intravenous (IV) insulin was tapered, and glucose was infused to clamp plasma glucose at 130 mg/dl for 24 h. Onset of action (defined as reduction of IV insulin >50%) was earlier with NPH (0.8 +/- 0.2 h), CSII (0.5 +/- 0.1 h), and ultralente (1 +/- 0.2 h) versus glargine (1.5 +/- 0.3 h) (P < 0.05) (mean +/- SE). End of action (defined as an increase in plasma glucose >150 mg/dl) occurred later with glargine (22 +/- 4 h) than with NPH (14 +/- 3 h) (P < 0.05) but was similar with ultralente (20 +/- 6 h). NPH and ultralente exhibited a peak concentration and action (at 4.5 +/- 0.5 and 10.1 +/- 1 h, respectively) followed by waning, whereas glargine had no peak but had a flat concentration/action profile mimicking CSII. Interindividual variability (calculated as differences in SD of plasma insulin concentrations and glucose infusion rates in different treatments) was lower with glargine than with NPH and ultralente (P < 0.05) but was similar with glargine and CSII (NS). In conclusion, NPH and ultralente are both peak insulins. Duration of action of ultralente is greater, but intersubject variability is also greater than that of NPH. Glargine is a peakless insulin, it lasts nearly 24 h, it has lower intersubject variability than NPH and ultralente, and it closely mimics CSII, the gold standard of basal insulin replacement.

Adult↗

PubMedDate not supplied

A comparison of premeal subcutaneous insulin infusion and injection in type I diabetic patients under continuous basal subcutaneous insulin delivery.

Blood glucose control under continuous subcutaneous insulin infusion (CSII) was assessed in five type I diabetic patients by measurement of mean blood glucose and M-values. These results were compared with the data obtained from treatment with constant basal subcutaneous insulin delivery supplemented by injection of regular insulin before meals into changing sites of the anterior abdominal wall. CSII treatment gave significantly (P less than 0.05) better results. It might be assumed that this is due to the more reliable insulin absorption from an unchanged site.

Adolescent↗

PubMed2001

Subcutaneous lymphoid hyperplasia arising at site of ethnic scarifications and mimicking subcutaneous panniculitis-like T-cell lymphoma.

The case of a 40-year-old black man, who developed a very unusual tumour-like lymphoid hyperplasia involving primarily the subcutaneous tissue, is reported. The lesion, which arose at a site of tribal scarifications, displayed a deceptive morphology that closely resembled subcutaneous panniculitis-like T-cell lymphoma (SPTCL). An accurate diagnosis could only be made following detailed immunohistochemical and molecular studies. Although SPTCL has been thought to represent a very specific clinicopathologic entity, the present case illustrates that its histological appearance can, however, be closely mimicked by reactive and benign conditions.

Adult↗

PubMed2005

Defibrillation energy requirements using a left anterior chest cutaneous to subcutaneous shocking vector: implications for a total subcutaneous implantable defibrillator.

BACKGROUND: Subcutaneous implantable defibrillators (ICDs) are being developed to facilitate ICD implantation. OBJECTIVE: The purpose of this study was to estimate the human defibrillation energy requirement (DER) using a left chest cutaneous (Q) to subcutaneous (SQ) shocking vector. METHODS: Twenty patients undergoing implantation of an indicated ICD were enrolled (15 males, age = 63 +/- 12 years; ejection fraction = 0.27 +/- 0.14). Defibrillation testing was performed using an investigational system consisting of an external defibrillator and a constructed connector to deliver a shock between a pectoral SQ can and a cardiac apical Q electrode. Two attempts at defibrillation using this configuration were allowed. Stage 1 testing started at 70 J with a step-down/step-up to 50 or 100 J, respectively. Stage 2 testing began at 50 J with a step-down/step-up to 30 or 70 J. RESULTS: During stage 1, a 70-J shock was successful in 7/9 (78%) patients. A second attempt was successful in 7/7 patients using a 50-J shock. In the two remaining patients, a second attempt using a 100-J shock was successful. During stage 2, a 50-J shock was successful in 10/11 (91%) patients. The protocol could not be completed in 2/11 patients. Of the remaining nine patients, a second defibrillation was successful in seven (78%) using a 30-J shock. CONCLUSIONS: The defibrillation energy requirement (DER) of this study vector was 50 J or less in most patients. This low DER supports further investigation of a totally SQ-ICD. However, the DER of 100 J in two patients indicates that further investigation is needed regarding DER variability and safety margins.

Aged↗

PubMed1989

Subcutaneous xanthogranulomatosis: an inflammatory non-X histiocytic syndrome (subcutaneous xanthomatosis).

The histopathologic features in four cases of subcutaneous xanthogranuloma were reviewed. All patients were elderly men and no associated diseases or hyperlipidemia were present. The microscopic picture was uniform in seven biopsy specimens: foam cells and masses circumscribed by Touton cells replacing the adipose tissue. Most cells, including foam cells, showed a positive reaction for the macrophage marker MAC387. Diffuse, sparse T cells and focal perivascular B cell nodules were identified. Electron microscopic examination showed histiocytes and lysosome-rich cells with myelin bodies. All patients are alive and well. We believe that we have identified a form of adult subcutaneous xanthogranuloma syndrome that can be initially confusing and lead to overdiagnosis and overtreatment.

Adult↗

PubMed2006

Accuracy of continuous subcutaneous glucose monitoring with the GlucoDay in type 1 diabetic patients treated by subcutaneous insulin infusion during exercise of low versus high intensity.

AIM: The GlucoDay allows continuous glucose monitoring by subcutaneous microdialysis in sedentary conditions. To validate it when glycaemia may undergo rapid and dramatic changes, we investigated its accuracy during two exercise sessions with markedly different glucose disposal rates. METHODS: Nine male diabetic patients, aged 32-61, treated by insulin pumps, first underwent a standard maximal exercise-test designed for determining the maximal oxygen consumption and the first ventilatory threshold (Vt1). Then two 30 min steady-state workloads at 15% below and 15% above the Vt1 were performed in random order with the GlucoDay, and measurement of CHO oxidation rates was made by indirect calorimetry. RESULTS: CHO oxidation during exercise at +15% Vt1 was higher (+943.5 mg/min, ie +45.5%, P<0.01) than during exercise at -15% Vt1 No hypoglycaemia occurred. Due to breakages of 39% of subcutaneous probes, eleven steady-state sessions in 7 subjects allowed to compare 141 paired glucose (sensor vs. venous) determinations. The Clarke error grid situates 92.9% of glucose values within the A zone and 6.4% within the B zone, while only one pair of values (0.7%) falls in the D zone. Venous glucose tended to decrease more rapidly than sensor glucose during exercise. Bland-Altman plots evidence for a few cases of underestimation of venous glucose at high intensity. CONCLUSIONS: This study showed satisfactory accuracy of the GlucoDay during exercise. A slight lag time in sensor values likely explains a few discrepancies that do not appear as clinically meaningful. Reduction of probe fragility and confirmed sensor accuracy in hypoglycaemia would further support applicability of GlucoDay at exercise.

Adult↗

PubMed1976

Lipoprotein lipase and hormone-sensitive lipase activities in human subcutaneous lipomas: comparison with normal subcutaneous adipose tissue.

1. Lipoprotein lipase activity and hormone-sensitive lipase activity were investigated in subcutaneous lipomas removed from two patients and compared with the enzyme activities in subcutaneous adipose tissue from two normal subjects. 2. Confirmation was obtained of the presence of lipoprotein lipase activity in lipomas with an activity fifteen to forty-five times that in the two control samples. 3. Hormone-sensitive lipase activity was demonstrated in lipomas under basal conditions of assay as well as in the presence of adrenaline plus theophylline. However, compared with the non-lipomatous fat samples, these activities were lower, as was the magnitude of the lipolytic response to adrenaline plus theophylline. 4. The significance of these measurements of enzyme activity and their role in the pathogenesis of lipomas are briefly discussed.

Adipose Tissue↗

PubMedDate not supplied

Variation of insulin absorption during subcutaneous and peritoneal infusion in insulin-dependent diabetic patients with unsatisfactory long-term glycaemic response to continuous subcutaneous insulin infusion.

The aim of present study was to analyse the reproducibility of plasma-free insulin profiles of subcutaneously (CSII) and intraperitoneally (CIPII) administered insulin in 6 C-peptide-negative, type 1, diabetic patients. The patients were selected for CIPII because of unsatisfactory, long-term, metabolic response to CSII. Plasma-free insulin was measured repeatedly, twice during subcutaneous infusion and twice during intraperitoneal infusion, for 4 hours, following a standard breakfast. In the CSII experiment, insulin was given as a meal-dose of 0.1 U per kg body weight, and in the CIPII experiment the meal-dose was 0.05 U per kg body weight. The dose-induced peak occurred earlier after the CIPII than with the CSII (60.0 +/- 8.0 vs 133.6 +/- 16.3 min). In conclusion, the intra-patient coefficient of variation (C.V.) of plasma-free-insulin profiles at 0-60 min and 0.240 min, as well as the peak time, were markedly lower for CIPII insulin than for CSII, indicating a more reproducible way of insulin administration with CIPII in this selected group of patients.

Absorption↗

PubMed1984

[Phlebography after total prosthesis. Action of subcutaneous sodium heparin in the prevention of thromboembolism. Results of therapeutic research with subcutaneous sodium heparin using 2 protocols in 250 patients monitored with phlebography].

Two series of patients on which total hip or knee prostheses had been inserted were studied. In the first series (150 cases), the patients were treated with low molecular Dextran and subcutaneous sodium heparin at a constant dosage. The Howell test was done every 3 days. The rate of post-operative thrombosis was 14 p. 100. In the second series (100 cases), the patients were treated with low molecular Dextran and subcutaneous sodium heparin with a variable dose adapted to the type of patient. The rate of post-operative thrombosis was only 7 p. 100. The insertion of a knee prosthesis was much more thrombogenic than hip prostheses. In the second series the rate of thrombosis after hip surgery was only 2 p. 100. However a number of complications relating to anticoagulation were a limiting factor of the method.

Clinical Trials as Topic↗

PubMed2004

Glycemic patterns detected by continuous subcutaneous glucose sensing in children and adolescents with type 1 diabetes mellitus treated by multiple daily injections vs continuous subcutaneous insulin infusion.

OBJECTIVE: To compare glycemic patterns by mode of therapy in children with type 1 diabetes mellitus using the Continuous Glucose Monitoring System (CGMS). DESIGN: Open randomized crossover comparing 3(1/2) months of multiple daily injections (MDI) and continuous subcutaneous insulin infusion (CSII). SETTING: Tertiary care, university-affiliated medical center. Patients Twenty-three children and adolescents with type 1 diabetes mellitus. INTERVENTIONS: The CGMS was applied for 72 hours after 1 month and at the end of each study arm. MAIN OUTCOME MEASURES: Hemoglobin A(1c) levels and glucose level profiles were compared between the 2 study arms and the 2 sensor applications for each arm. RESULTS: The arms were similar for mean (SD) hemoglobin A(1c) levels (CSII, 8.0% [0.8%]; and MDI, 8.2% [0.8%]) and glucose levels. Areas under the curve were significantly larger during MDI for nocturnal and 24-hour hypoglycemia (P =.01 and.04, respectively) and for postprandial hypoglycemia and hyperglycemia (P =.03 and.05, respectively). The rate of hyperglycemia increased during CSII (P =.03), but 24-hour duration and area under the curve for hyperglycemia were similar. Compared with the first CGMS reading in each arm, the second had a longer mean duration of postprandial within-target glucose levels (P =.04), tendency for lower rate of diurnal hypoglycemic events (P =.1), shorter duration of nocturnal hypoglycemia (P =.05), and smaller 24-hour area under the curve for hypoglycemia (P =.04). CONCLUSIONS: Intensive treatment with CSII seemed to be associated with slightly better prebreakfast, postprandial, and within-target glucose profiles than MDI, as well as a smaller area under the curve for hypoglycemia. Lower hypoglycemia-related variables in the second sensor reading in each arm indicate that the CGMS may serve as an educational tool to decrease the rate and magnitude of hypoglycemia.

Adolescent↗

PubMed1993

Comparison of hydromorphone continuous subcutaneous infusion and basal rate subcutaneous infusion plus PCA in cancer pain: a pilot study.

In this pilot randomized, double-blind, cross-over study, the effectiveness and safety of hydromorphone administration by continuous subcutaneous (s.c.) infusion (mode A) and by continuous basal rate s.c. infusion + PCA (mode B) were compared in 8 cancer patients. Patients experimented with each infusion mode during 48 h. Statistical analysis was performed on data collected in 7 patients during 36 h from 22:00 h on day 1 to 10:00 h on day 3 and from 22:00 h on day 3 to 10:00 h on day 5. Mean hydromorphone dose +/- S.D. was 56.6 +/- 30.1 and 40.4 +/- 24.5 mg/36 h for modes A and B, respectively. There was no statistically significant difference observed in mean pain intensity, but the absence of significant difference may be related to the small sample size and high individual variability. Both methods provided adequate overall pain control in most patients. However, a large interindividual variation was detected. Indeed, some patients reported in the subjective questionnaire that they felt marked discomfort during hydromorphone administration with mode B. Only 2 patients chose mode B at the end of the study, but it was interesting to note that those 2 patients were the youngest of the group. This study demonstrated the effectiveness and safety of both modes of hydromorphone administration. The data suggest that it may be possible to identify particular cancer patients which can really benefit from an association of a basal rate infusion and PCA for opiate administration.

Adult↗

PubMed2006

Phase II trial of subcutaneous recombinant human interleukin 11 with subcutaneous recombinant human granulocyte-macrophage colony stimulating factor in patients with acute myeloid leukemia (AML) receiving high-dose cytarabine during induction: ECOG 3997.

Randomized trials of substituting high-dose cytarabine (HiDAC) for standard dose cytarabine (SDAC) during induction therapy for newly diagnosed AML have not demonstrated an improvement in the complete remission (CR) rate. Phase II trials of the scheduled administration of HiDAC after SDAC suggest an improved outcome. The hematological complications of intensification are considerable. GM-CSF after chemotherapy improved the survival of older patients in a randomized trial. Recombinant human interleukin 11, a thrombopoietic cytokine, reduced the incidence of chemotherapy-induced thrombocytopenia in patients with solid tumors. Therefore, 34 patients were treated, with newly diagnosed AML less than 56 years of age, with daunorubicin 45 mg/m2 on days 1-3, cytarabine 100mg/m2 days 1-7 and cytarabine 2g/m2 for 12 h on days 8-10 (7+3+3). rhIL-11 (50 microg/kg/day,) and GM-CSF (250 microg/kg/day) were administered subcutaneously from day 11 until recovery. The complete remission rate was 59% (90% C.I. 43-73%). The median time to recovery of neutrophils to >500 and platelets to > or =20,000 microl(-1) was 27 days (95% C.I. 27-30 days) and 25 days (95% C.I. 24-29 days), respectively. The trial does not confirm the high CR rate observed in phase II trials, despite optimal supportive care.

Acute Disease↗