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Biomedical subjects

R J Cunningham

Publications and source records attributed to R J Cunningham.

At least 19 recordsLinked to original sources

Screening for eligibility in the study of antihypertensive medication in children: experience from the Ziac Pediatric Hypertension Study.

BACKGROUND: The FDA Modernization Act has resulted in an increase in pediatric trials of antihypertensive medications. As experience is limited in children to guide the planning of these studies, we reviewed data from the Ziac Pediatric Hypertension Study to determine patterns of early study termination to help future studies. METHODS: For inclusion, subjects aged 6 to 17 years were required to have an average systolic blood pressure (SBP) or diastolic blood pressure (DBP) above the 95th percentile at the last of three visits during 2 weeks of single-blind placebo screening. Early study termination was defined as early termination for any reason. Screening termination was defined as normalization of blood pressure (BP) during the placebo screening phase. RESULTS: Early study termination rate was 27% (38 of 140 subjects). The most common reason was screening termination due to normalization of BP, accounting for 63% of all early study terminations. Among screening termination subjects who completed three screening visits, SBP was higher (P < .001) at visit 1 (129+/-8 mm Hg) than at visit 2 (123+/-7 mm Hg) or visit 3 (121+/-8 mm Hg), but did not differ between visits 2 and 3. Screening termination occurred in 15% with isolated SBP hypertension, and 21% with isolated DBP hypertension. At randomization, 83% had SBP hypertension and 53% had DBP hypertension. CONCLUSIONS: These data suggest that SBP hypertension should be part of inclusion criteria to increase enrollment and reduce the rate of screening termination, and that 1-week placebo screening is necessary and sufficient to minimize inclusion of transiently hypertensive subjects.

Adolescent↗

Tacrolimus: the good, the bad, and the ugly.

The aim of this study was to evaluate the efficacy and side-effects of tacrolimus in pediatric transplant patients previously receiving cyclosporin A (CsA). This study was a retrospective chart review strengthened by a concomitant patient interview. Eleven pediatric cardiac or renal transplant patients, who had been converted from CsA to tacrolimus from October 1995 to January 1999 at The Cleveland Clinic Foundation, were included; there were six renal and five cardiac transplant patients. Each chart was reviewed to assess transplanted organ function pre- and post-conversion. For the six renal transplant patients, creatinine levels and biopsy findings were evaluated. For the five cardiac transplant patients, cardiac catheterization and routine biopsy data were analyzed likewise. Epstein Barr virus (EBV) status was also evaluated in each patient. In addition, each parent or patient was interviewed to ascertain dates of transplant, current medications, and side-effects. The patients' ages ranged from 6 to 20 yr (mean age 14.6 yr). All patients had been converted to tacrolimus. Eight patients were converted for treatment of refractory rejection, two were converted because of CsA-associated side-effects, and one patient was converted empirically for a history of multiple previous transplant rejections. Seven out of eight patients who received tacrolimus for rejection therapy improved. One patient had complete resolution of gingival hyperplasia. Another patient who previously developed hemolytic uremic syndrome on CsA had no further evidence of hemolysis. Four patients were weaned off steroid therapy. Despite conversion, two renal transplant patients progressed to chronic rejection. Five patients exhibited no side-effects. Side-effects experienced included transient hyperglycemia in conjunction with steroid use, headaches, and tremors that subsided rapidly. Four of 11 patients developed post-transplant lymphoproliferative disease (PTLD). Fortunately, reducing the dose of tacrolimus and/or surgical resection of the mass (if present), eradicated the disease. In conclusion, conversion therapy successfully provides an alternate treatment for acute rejection. It also enabled some patients to discontinue steroid therapy, maximizing growth potential. PTLD is a severe, potentially life-threatening complication that needs to be recognized and monitored closely. In conclusion, tacrolimus has been shown to be a very effective agent for the treatment of refractory organ rejection, but must be used cautiously.

Adjuvants, Immunologic↗

Renal stone disease in children.

Renal stone disease has been regarded as an uncommon problem in children compared to adults. However, increased awareness of this problem in children may lead to early intervention preventing long-term consequences on the kidney and the urinary tract. This article reviews the epidemiology, pathogenesis, and the most common etiologies of renal stones in children. The clinical features and diagnostic and therapeutic modalities for the specific etiologies are also outlined. Using these guidelines may be helpful not only in the treatment but also in the prevention of renal stones.

Adult↗

Chronic tubulo-interstitial nephropathy in children with cranioectodermal dysplasia.

We report two pairs of siblings with the syndrome cranioectodermal dysplasia who have subsequently developed chronic renal failure secondary to tubulo-interstitial nephropathy. Renal disease has not been described before in this rare syndrome but has now occurred in four of the seven reported cases. Children with cranioectodermal dysplasia appear to be at significant risk of developing chronic renal failure. This is important information for clinicians looking after such children, and their families, when considering the long-term prognosis and management.

Child, Preschool↗

Safety and cost effectiveness of pediatric percutaneous renal biopsy.

Because of the rising cost of health care, more patients are undergoing procedures as outpatients rather than inpatients. The purpose of this study was to compare safety and cost of outpatient versus inpatient, overnight stay, for children undergoing percutaneous renal biopsy. Charts of all such patients between January 1989 through January 1995 were reviewed for the following: age of patient, native versus allograft biopsy and preparation costs (in 1995 U.S. dollars), and complications. Of the 75 biopsies reviewed, 58 were native and 17 allograft with 35 (47%) of the biopsies being outpatient and 40 (53%) inpatient. There were four complications (11.4%) in 2 patients for the outpatient group and seven complications (17.5%) in 6 patients in the inpatient group (X2 = 0.1003, P = 0.75). The median cost for an outpatient biopsy was U.S. $1,968 while an inpatient biopsy was U.S. $3,178. We conclude that outpatient percutaneous renal biopsy in children is as safe as inpatient and more economic, with a saving of greater than U.S. $1,000 per biopsy.

Ambulatory Care↗

Cognitive functioning and school performance in children with renal failure.

Although previous studies have documented neuropsychological deficits in children with end-stage renal disease, few have evaluated and compared the cognitive functioning and the school performance of children with renal failure. The current study evaluated the influence of chronic renal failure on cognitive functioning and school performance in children and adolescents with end-stage renal disease undergoing dialysis and after renal transplantation. Participants were given standardized IQ and achievement tests to assess cognitive functioning and ability. Academic performance was determined by evaluating grades for the semester in which the testing was performed; a grade point average (GPA) was calculated based on a 4.0-point scale. The 11 dialysis patients and 13 transplant patients were comparable in age, race, sex, and socioeconomic status. Overall IQ and subtest scores demonstrated no differences between the two groups. Performance on the Woodcock-Johnson achievement tests showed that the transplant patients did better on achievement tests of written language (P = 0.04) and in school performance in English compared with dialysis patients (P < 0.05). Furthermore the dialysis patients tended to be below age and grade level in all areas, whereas the transplant patients were achieving at or above these levels. There were significant differences in the age equivalent scores between the dialysis and transplant patients in the areas of mathematics and written language (P < 0.05). However, when grades were evaluated there were no differences in overall GPA or in the mathematics GPA. Days absent were not different between the two groups.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

Farmer's hip.

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Aged↗

The outcome of renal transplantation in children without prolonged pre-transplant dialysis.

Controversy in the literature exists over whether or not it is beneficial to maintain a patient on dialysis for a prolonged time before transplantation. Because no data exist comparing children who have had prolonged dialysis before transplantation to those who have none, we reviewed the charts of all children transplanted at the Children's Hospital of the Cleveland Clinic Foundation. Of those, we selected three groups for analysis: group one (n = 12) consisted of patients who had had less than or equal to 10 weeks of dialysis before transplantation (6.8 +/- -2.2 weeks, +/- = SD); group two (n = 21) were patients who had had more than 10 weeks of dialysis (142 + +/- -148 weeks). Both groups had two years of follow-up data. Group three (n = 13) consisted of patients who had had less than two years of follow-up (18.7 +/-/-7 months) but no dialysis before transplantation. There were no differences in mode of dialysis between groups one and two nor in the type of transplant (living-related donor vs. cadaveric). Significantly, the patients in group three received more cyclosporine A and less anti-lymphocyte globulin than the other two groups (p less than 0.05). Patients in group two received more transfusions (11.9 +/- 14.3) than patients in group one (4.0 +/- 2.7) and group three (3.5 +/- 7.3). There were no differences in number of patients who experienced at least one rejection episode among the three groups. Although the mean serum creatinine concentration at two years of follow-up was higher in group two (3.6 +/- -3.9 mg/dl), this was not significantly different from group one (1.7 +/- -0.7 mg/dl) or group three (1.9 +/- -0.5, n = 7). Sixty-three percent of patients in group one, 60% of patients in group two and 91% in group three had functioning allografts at two years follow-up. Although there may be other considerations, our data do not indicate any increase in rejection or decrease in graft survival in children who do not receive prolonged dialysis.

Adolescent↗

Detrimental effect of cyclosporine on initial function of cadaver renal allografts following extended preservation. Results of a randomized prospective study.

We report herein the results of a randomized prospective trial comparing maintenance cyclosporine (CsA)-prednisone immunosuppression to a regimen of azathioprine-prednisone-antilymphocyte globulin (ALG) in cadaver renal transplant recipients. Fifty-six patients were entered into this study with 31 assigned to the ALG group and 25 to the CsA group. These two groups were well matched for most major determinants of graft outcome and the mean renal preservation time was 37 hr in each group. The incidence of acute tubular necrosis (ATN) was high in both groups (58% ALG, 72% CsA, NS). There were five cases of primary nonfunction in the CsA group and only one in the ALG group (P = .05). Of the kidneys that functioned, the mean serum creatinine nadir (1.5 vs. 2.2 mg/dl, P = .06) and the mean number of days to reach the serum creatinine nadir (24.2 vs. 43.3 days, P = .03) were both less in the ALG group. The actuarial one-year graft survival rate in the ALG and CsA groups is 78% and 48%, respectively (P less than .05). This difference is mainly due to the large number of primary nonfunctioning grafts in the latter group, which we attribute to the effect of CsA's nephrotoxicity superimposed on renal ischemia incurred prior to transplantation. These data emphasize that, in order to realize the full benefit of CsA in cadaver transplantation, renewed emphasis must be placed on minimizing ischemic renal damage.

Adolescent↗

Urinary tract infection in infants and children. Preventing recurrence and renal damage.

The major goal in treating urinary tract infection in children is to preserve renal parenchyma. Therefore, children with suspected pyelonephritis or anatomic abnormalities need to be examined thoroughly with the first infection. Any child with three infections should have intravenous pyelography and voiding cystourethrography, even if infections appear to be limited to the lower urinary tract. Recurrence of urinary tract infections is a major problem, and a program of follow-up urine cultures should be instituted after the first infection. Such an approach allows for early detection of anatomic abnormalities or reinfection, thus preventing loss of renal parenchyma and hence of renal function.

Aging↗