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Roberta J Navickis

Publications and source records attributed to Roberta J Navickis.

7 recordsLinked to original sources
PubMed2004

A systematic review of the comparative safety of colloids.

HYPOTHESIS: Safety differences exist among colloids widely used for fluid management in acutely ill patients, as judged according to the comparative incidence of adverse events. DATA SOURCES: Colloid safety data for human subjects were sought, without language or time period restrictions, by means of computer searches of bibliographic and clinical trial databases, hand searches of medical journals and Index Medicus, inquiries with investigators and colloid suppliers, and examination of reference lists. Search terms included "colloids", "morbidity", and "mortality". STUDY SELECTION: Controlled trials, cohort studies, pharmacovigilance studies, and prior meta-analyses were independently selected by 2 unblinded investigators. Of 189 candidate studies, 113 were included, with safety data encompassing 1.54 x 10(6) patients and 1.09 x 10(8) colloid infusions. DATA EXTRACTION: Two unblinded investigators independently extracted data. Study limitations and confounding factors were tabulated. DATA SYNTHESIS: With albumin as the reference colloid, the incidence rate ratio for anaphylactoid reactions was 4.51 (95% confidence interval, 2.06-9.89) after hydroxyethyl starch administration, 2.32 (95% confidence interval, 1.21-4.45) after dextran, and 12.4 (95% confidence interval, 6.40-24.0) after gelatin. Pruritus occurrence was significantly increased by hydroxyethyl starch exposure (odds ratio, 1.78; 95% confidence interval, 1.23-2.58). Artificial colloid administration was consistently associated with coagulopathy and clinical bleeding, most frequently in cardiac surgery patients receiving hydroxyethyl starch. On the basis of large-scale pharmacovigilance study results, albumin infusion resulted in a low rate of both total adverse events (3.1 to 8.6 per 10(5) infusions) and serious adverse events (1.29 per 10(6) infusions). CONCLUSIONS: Significant safety differences exist among colloids. Therefore, conclusions regarding the clinical usefulness of colloids as a fluid class should be formed with caution.

Albumins↗
PubMed2004

Albumin versus crystalloid for pump priming in cardiac surgery: meta-analysis of controlled trials.

OBJECTIVES: To determine the effects of pump priming fluid choice on platelets, fluid balance, and clinical outcomes. DESIGN: Meta-analysis of controlled clinical trials. Primary endpoints were platelet counts, colloid oncotic pressure, on-bypass fluid balance, postoperative weight gain, and colloid usage. SETTING: Cardiac surgery with cardiopulmonary bypass. PATIENTS: Adult and pediatric patients undergoing cardiac surgery, including coronary artery bypass grafting, valve procedures, and correction of congenital cardiac anomalies. INTERVENTIONS: Extracorporeal circuit priming with either albumin or crystalloid. MEASUREMENTS AND RESULTS: The meta-analysis included 21 controlled trials with 1,346 total patients. Albumin prime significantly reduced the on-bypass drop in platelet counts. The pooled weighted mean difference in platelet count drop with albumin versus crystalloid prime was -23.8 x 10(9)/L (confidence interval [CI], -42.8 to -4.7 x 10(9)/L). The colloid oncotic pressure decline was also smaller when albumin rather than crystalloid was used for priming, with a pooled weighted mean difference of -3.6 mm Hg (CI, -4.8 to -2.3 mmHg) during bypass and -2.0 mmHg (CI, -2.9 to -1.1 mmHg) after surgery. Albumin prime correspondingly reduced on-bypass positive fluid balance (-584 mL; CI, -819 to -348 mL) and postoperative weight gain (-1.0 kg; CI, -0.6 to -1.3 kg) compared with crystalloid. Postoperative colloid usage was lower with albumin than crystalloid prime (-612 mL; CI, -983 to -241 mL). CONCLUSIONS: Albumin prime better preserves platelet counts than crystalloid. Albumin also favorably influences colloid oncotic pressure, on-bypass positive fluid balance, postoperative weight gain, and colloid usage. The clinical significance of these observations merits further investigation.

Adult↗
PubMed2004

Update on research, diagnosis and management of alphal-antitrypsin deficiency.

Formed in response to a World Health Organization recommendation, the Alpha One International Registry (AIR) is a multinational research program focused on alphal-antitrypsin (AAT) deficiency. Each of the nearly 20 participating countries maintains a National Registry of patients with AAT deficiency and contributes to an international database in Malmö, Sweden, that is designed to increase understanding of AAT deficiency as well as safeguard patient confidentiality. AIR members are engaged in active and wide-ranging investigations to improve the diagnosis, monitoring and therapy of the disease. The AIR membership meets biennially to exchange views and research findings. The third biennial meeting was held in Barcelona, Spain, June 11 -13, 2003. A wide range of AAT deficiency-related topics were addressed, encompassing molecular and cellular pathophysiologic mechanisms, clinical epidemiology, diagnostic advances, current and investigational therapeutic approaches, and progress in registry development. Valuable cross-fertilization of concepts and scientific observations was apparent between AAT deficiency research and other fields of biomedicine. The proceedings of the meeting are summarized in this report.

Biomedical Research↗
PubMed2004

Morbidity in hospitalized patients receiving human albumin: a meta-analysis of randomized, controlled trials.

OBJECTIVE: To determine the effect of albumin administration on morbidity in acutely ill hospitalized patients. DATA SOURCE: Computer searches of MEDLINE, EMBASE, and the Cochrane Library; hand searches of journals and Index Medicus; inquiries with investigators and fluid product suppliers; and examination of reference lists. No language or time period restrictions were adopted. STUDY SELECTION: Randomized, controlled trials comparing the administration of albumin with that of crystalloid, no albumin, or lower-dose albumin. DATA EXTRACTION: Two investigators independently extracted data. The primary endpoint for the meta-analysis was morbidity, defined as the incidence of complications, including death. Trial quality was evaluated by blinding, allocation concealment, presence of morbidity as a study endpoint, and individual patient crossover. DATA SYNTHESIS: Seventy-one trials were included in the categories of surgery or trauma, burns, hypoalbuminemia, high-risk neonates, ascites, and other indications. The 3,782 randomized patients in the included trials experienced a total of 3,287 complications, including 515 deaths and 2,772 cardiovascular, gastrointestinal, hepatic, infectious, renal, respiratory, and other complications. Albumin significantly reduced overall morbidity, with a risk ratio of 0.92 (confidence interval [CI], 0.86-0.98). Control group albumin dose significantly affected the incidence of complications (p = .002). In 32 trials with no albumin administered to the control group, the risk ratio was 0.77 (CI, 0.67-0.88) compared with 0.89 (CI, 0.80-1.00) in 20 trials with control patients receiving low-dose albumin and 1.07 (CI, 0.96-1.20) in 19 trials with moderate-dose control group albumin. CONCLUSIONS: Albumin reduces morbidity in acutely ill hospitalized patients. Concomitant administration of albumin in the control group can obscure the effects of albumin on clinical outcome in randomized trials.

Acute Disease↗
PubMed2003

Hypoalbuminemia in acute illness: is there a rationale for intervention? A meta-analysis of cohort studies and controlled trials.

OBJECTIVE: To determine whether hypoalbuminemia is an independent risk factor for poor outcome in the acutely ill, and to assess the potential of exogenous albumin administration for improving outcomes in hypoalbuminemic patients. SUMMARY BACKGROUND DATA: Hypoalbuminemia is associated with poor outcomes in acutely ill patients, but whether this association is causal has remained unclear. Trials investigating albumin therapy to correct hypoalbuminemia have proven inconclusive. METHODS: A meta-analysis was conducted of 90 cohort studies with 291,433 total patients evaluating hypoalbuminemia as an outcome predictor by multivariate analysis and, separately, of nine prospective controlled trials with 535 total patients on correcting hypoalbuminemia. RESULTS: Hypoalbuminemia was a potent, dose-dependent independent predictor of poor outcome. Each 10-g/L decline in serum albumin concentration significantly raised the odds of mortality by 137%, morbidity by 89%, prolonged intensive care unit and hospital stay respectively by 28% and 71%, and increased resource utilization by 66%. The association between hypoalbuminemia and poor outcome appeared to be independent of both nutritional status and inflammation. Analysis of dose-dependency in controlled trials of albumin therapy suggested that complication rates may be reduced when the serum albumin level attained during albumin administration exceeds 30 g/L. CONCLUSIONS: Hypoalbuminemia is strongly associated with poor clinical outcomes. Further well-designed trials are needed to characterize the effects of albumin therapy in hypoalbuminemic patients. In the interim, there is no compelling basis to withhold albumin therapy if it is judged clinically appropriate.

Acute Disease↗