Albumin infusion reduces the incidence of postparacentesis circulatory dysfunction among patients with cirrhosis and tense ascites, as compared with no treatment. Treatment alternatives to albumin, ...such as artificial colloids and vasoconstrictors, have been widely investigated. The aim of this meta‐analysis was to determine whether morbidity and mortality differ between patients receiving albumin versus alternative treatments. The meta‐analysis included randomized trials evaluating albumin infusion in patients with tense ascites. Primary endpoints were postparacentesis circulatory dysfunction, hyponatremia, and mortality. Eligible trials were sought by multiple methods, including computer searches of bibliographic and databases and the Cochrane Library. Results were quantitatively combined under a fixed‐effects model. Seventeen trials with 1,225 total patients were included. There was no evidence of heterogeneity or publication bias. Compared with alternative treatments, albumin reduced the incidence of postparacentesis circulatory dysfunction (odds ratio OR, 0.39; 95% confidence interval CI, 0.27‐0.55). Significant reductions in that complication by albumin were also shown in subgroup analyses versus each of the other volume expanders tested (e.g., dextran, gelatin, hydroxyethyl starch, and hypertonic saline). The occurrence of hyponatremia was also decreased by albumin, compared with alternative treatments (OR, 0.58; 95% CI, 0.39‐0.87). In addition, mortality was lower in patients receiving albumin than alternative treatments (OR, 0.64; 95% CI, 0.41‐0.98). Conclusions: This meta‐analysis provides evidence that albumin reduces morbidity and mortality among patients with tense ascites undergoing large‐volume paracentesis, as compared with alternative treatments investigated thus far. (HEPATOLOGY 2012)
Objective The effects of hydroxyethyl starch on bleeding after cardiopulmonary bypass were determined. Methods A meta-analysis was performed of postoperative blood loss in randomized clinical trials ...of hydroxyethyl starch versus albumin for fluid management in adult cardiopulmonary bypass surgery. Impacts of hydroxyethyl starch molecular weight and molar substitution were assessed. Randomized trials directly comparing different hydroxyethyl starch solutions were also included. Results Eighteen trials with 970 total patients were included. Compared with albumin, hydroxyethyl starch increased postoperative blood loss by 33.3% of a pooled SD (95% confidence interval, 18.2%–48.3%; P < .001). Risk of reoperation for bleeding was more than doubled by hydroxyethyl starch (relative risk, 2.24; 95% confidence interval, 1.14–4.40; P = .020). Hydroxyethyl starch increased transfusion of red blood cells by 28.4% of a pooled SD (95% confidence interval, 12.2%–44.6%; P < .001), of fresh-frozen plasma by 30.6% (95% confidence interval, 8.0%–53.1%; P = .008), and of platelets by 29.8% (95% confidence interval, 3.4%–56.2%; P = .027). None of these effects differed significantly between hydroxyethyl starch 450/0.7 and 200/0.5. Insufficient data were available for hydroxyethyl starch 130/0.4 versus albumin; however, no significant differences were detected in head-to-head comparisons of hydroxyethyl starch 130/0.4 with 200/0.5. Albumin improved hemodynamics. There were no differences in fluid balance, ventilator time, intensive care unit stay, or mortality. Conclusions Hydroxyethyl starch increased blood loss, reoperation for bleeding, and blood product transfusion after cardiopulmonary bypass. There was no evidence that these risks could be mitigated by lower molecular weight and substitution.
Abstract Primary immunodeficiency disease (PIDD) associated with hypogammaglobulinemia is typically treated with immunoglobulin replacement therapy. When administered as intravenous immunoglobulin ...(IVIG), an IgG trough occurs prior to the next replacement dose. While frequently measured, IgG trough levels required to minimize infection risk are not established. To address this question, all available studies evaluating trough IgG and pneumonia incidence in PIDD patients with hypogammaglobulinemia receiving IVIG were quantitatively combined by meta-analysis. Seventeen studies with 676 total patients and 2,127 patient-years of follow-up were included. Pneumonia incidence declined by 27% with each 100 mg/dL increment in trough IgG (incidence rate ratio, 0.726; 95% confidence interval, 0.658–0.801). Pneumonia incidence with maintenance of 500 mg/dL IgG trough levels (0.113 cases per patient-year) was 5-fold that with 1000 mg/dL (0.023 cases per patient-year). This meta-analysis provides evidence that pneumonia risk can be progressively reduced by higher trough IgG levels up to at least 1000 mg/dL.
Background & Aims Renal impairment increases mortality among patients with spontaneous bacterial peritonitis (SBP), despite administration of non-nephrotoxic antibiotics. Albumin infusion has been ...reported to reduce renal impairment and mortality in patients with SBP. We performed a meta-analysis of randomized controlled trials (RCTs) to quantify the effect of albumin infusion on renal impairment and mortality in patients with SBP. Methods We searched MEDLINE, EMBASE, the Cochrane Library, and ClinicalTrials.gov for RCTs that evaluated albumin treatment for patients with SBP; we also performed searches by additional methods. Four trials of 288 total patients were included in our analysis. Data were quantitatively combined under a fixed-effects model. Results We found no evidence of statistically significant heterogeneity or publication bias among the studies analyzed. Albumin was compared with no albumin in 3 trials and with artificial colloid in 1 trial. All patients received antibiotics. The incidence of renal impairment in control groups was 44 of 144 (30.6%), compared with 12 of 144 (8.3%) in groups given albumin. The pooled odds ratio for a reduction in renal impairment after albumin infusion was 0.21 (95% confidence interval, 0.11–0.42). Odds ratios for renal impairment after albumin therapy ranged from 0.19–0.30 among the individual studies. Mortality among controls was 51 of 144 (35.4%), compared with 23 of 144 (16.0%) among patients who received albumin. The pooled odds ratio for decreased mortality after infusion of albumin was 0.34 (95% confidence interval, 0.19–0.60). Odds ratios for mortality in individual RCTs ranged from 0.16–0.55. Conclusions In a meta-analysis of 4 RCTs (288 patients), albumin infusion prevented renal impairment and reduced mortality among patients with SBP.
Recommended treatment for type 1 hepatorenal syndrome consists of albumin and vasoconstrictor. The optimal albumin dose remains poorly characterized. This meta-analysis aimed to determine the impact ...of albumin dose on treatment outcomes.
Clinical studies of type 1 hepatorenal syndrome treatment with albumin and vasoconstrictor were sought. Search terms included: hepatorenal syndrome; albumin; vasoconstrictor; terlipressin; midodrine; octreotide; noradrenaline; and norepinephrine. A meta-analysis was performed of hepatorenal syndrome reversal and survival in relation to albumin dose.
Nineteen clinical studies with 574 total patients were included, comprising 8 randomized controlled trials, 8 prospective studies and 3 retrospective studies. The pooled percentage of patients achieving hepatorenal syndrome reversal was 49.5% (95% confidence interval, 40.0-59.1%). Increments of 100 g in cumulative albumin dose were accompanied by significantly increased survival (hazard ratio, 1.15; 95% confidence interval, 1.02-1.31; p = 0.023). A non-significant increase of similar magnitude in hepatorenal syndrome reversal was also observed (odds ratio, 1.15; 95% confidence interval, 0.97-1.37; p = 0.10). Expected survival rates at 30 days among patients receiving cumulative albumin doses of 200, 400 and 600 g were 43.2% (95% confidence interval, 36.4-51.3%), 51.4% (95% confidence interval, 46.3-57.1%) and 59.0% (95% confidence interval, 51.9-67.2), respectively. Neither survival nor hepatorenal syndrome reversal was significantly affected by vasoconstrictor dose or type, treatment duration, age, baseline serum creatinine, bilirubin or albumin, baseline mean arterial pressure, or study design, size or time period.
This meta-analysis suggests a dose-response relationship between infused albumin and survival in patients with type 1 hepatorenal syndrome. The meta-analysis provides the best current evidence on the potential role of albumin dose selection in improving outcomes of treatment for type 1 HRS and furnishes guidance for the design of future dose-ranging studies.
Critical appraisal of outcomes after burn shock resuscitation with albumin has previously been restricted to small relatively old randomized trials, some with high risk of bias. Extensive recent data ...from nonrandomized studies assessing the use of albumin can potentially reduce bias and add precision. The objective of this meta-analysis was to determine the effect of burn shock resuscitation with albumin on mortality and morbidity in adult patients. Randomized and nonrandomized controlled clinical studies evaluating mortality and morbidity in adult patients receiving albumin for burn shock resuscitation were identified by multiple methods, including computer database searches and examination of journal contents and reference lists. Extracted data were quantitatively combined by random-effects meta-analysis. Four randomized and four nonrandomized studies with 688 total adult patients were included. Treatment effects did not differ significantly between the included randomized and nonrandomized studies. Albumin infusion during the first 24 hours showed no significant overall effect on mortality. However, significant statistical heterogeneity was present, which could be abolished by excluding two studies at high risk of bias. After those exclusions, albumin infusion was associated with reduced mortality. The pooled odds ratio was 0.34 with a 95% confidence interval of 0.19 to 0.58 (P < .001). Albumin administration was also accompanied by decreased occurrence of compartment syndrome (pooled odds ratio, 0.19; 95% confidence interval, 0.07-0.50; P < .001). This meta-analysis suggests that albumin can improve outcomes of burn shock resuscitation. However, the scope and quality of current evidence are limited, and additional trials are needed.
To test the hypothesis that albumin administration is not associated with excess mortality.
Computer searches of the MEDLINE and EMBASE databases, the Cochrane Library, and Internet documents; hand ...searching of medical journals; inquiries to investigators and medical directors; and review of reference lists.
Randomized, controlled trials comparing albumin therapy with crystalloid therapy, no albumin, or lower doses of albumin.
Two investigators independently extracted data. The primary end point was relative risk for death. Criteria used to assess methodologic quality were blinding, method of allocation concealment, presence of mortality as a study end point, and crossover. Small-trial bias was also investigated.
Fifty-five trials involving surgery or trauma, burns, hypoalbuminemia, high-risk neonates, ascites, and other indications were included. Albumin administration did not significantly affect mortality in any category of indications. For all trials, the relative risk for death was 1.11 (95% CI, 0.95 to 1.28). Relative risk was lower among trials with blinding (0.73 CI, 0.48 to 1.12; n = 7), mortality as an end point (1.00 CI, 0.84 to 1.18; n = 17), no crossover (1.04 CI, 0.89 to 1.22; n = 35), and 100 or more patients (0.94 CI, 0.77 to 1.14; n = 10). In trials with two or more such attributes, relative risk was further reduced.
Overall, no effect of albumin on mortality was detected; any such effect may therefore be small. This finding supports the safety of albumin. The influence of methodologic quality on relative risk for death suggests the need for further well-designed clinical trials.
To provide an updated systematic review on the comparative safety of colloids based on recent clinical studies.
Recent investigations, including large-scale randomized trials and meta-analyses, have ...sought to determine the effects of colloids on mortality and morbidity. Hypothesized differences in safety profile between hydroxyethyl starch (HES) solutions have also been evaluated in randomized trials.
Clinical studies reported since 2002 with safety data for acutely ill patients receiving HES, gelatin, dextran, or albumin were sought by computer searches and other methods. Safety endpoints included mortality, morbidity, bleeding and impaired coagulation, and acute kidney injury (AKI). Data extracted from the included study reports were qualitatively summarized.
Sixty-nine clinical studies were included. Of those, 42 were randomized controlled trials (RCTs) with 10,382 total patients. New safety data, since 2002, predominantly concerned albumin or HES. A large RCT of intensive care unit patients showed that albumin does not adversely affect survival. Acute kidney injury and a dose-dependent increase in mortality were observed in a large RCT of patients with severe sepsis or septic shock receiving HES. Impaired coagulation and clinical bleeding were frequently reported after HES infusion, especially in cardiac surgery. In head-to-head randomized comparisons of different HES solutions, observed effects on coagulation and renal function were similar. Gelatin showed less impairment of coagulation than HES. Very few safety data related to dextran were identified.
Albumin displayed a more favorable safety profile than HES. Available evidence does not support the existence of consistent safety differences between HES solutions.
Background. Augmentation with exogenous α1-antitrypsin (α1-AT) is the only specific therapy for α1-AT deficiency. Uncertainty persists concerning its effectiveness. Purpose. To test the hypothesis ...that augmentation therapy in patients with α1-AT deficiency slows the decline in FEV1. Study Selection. Randomized and nonrandomized clinical studies with either parallel-group design or single cohort pre-post design were eligible if they compared augmentation therapy with a control regimen and if long-term (> 1 y) longitudinal FEV1 follow-up data were collected. Data Synthesis. FEV1 data from five trials with 1509 patients were combined by random effects meta-analysis. The decline in FEV1 was slower by 23% (absolute difference, 13.4 ml/year; CI, 1.5 to 25.3 ml/year) among all patients receiving augmentation therapy. This overall protective effect reflected predominantly the results in the subset of patients with baseline FEV1 30-65% of predicted. In that subset, augmentation was associated with a 26% reduction in rate of FEV1 decline (absolute difference, 17.9 ml/year; CI, 9.6 to 26.1 ml/year). Similar trends amongst patients with baseline FEV1 percent of predicted < 30% or > 65% were not statistically significant. Conclusions. This meta-analysis supports the conclusion that augmentation can slow lung function decline in patients with AAT deficiency Patients with moderate obstruction are most likely to benefit.
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