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Table 1 Trial characteristics

From: Albumin versus crystalloid solutions in patients with the acute respiratory distress syndrome: a systematic review and meta-analysis

Trial Population Intervention Outcome
(sample size) Inclusion criteria Exclusion criteria Treatment Control Primary Secondary
Martin [29] (n = 37) 1) The American-European Consensus Conference definition for ALI [14]; 2) serum total protein level of 5.0 g/dL; 3) ongoing nutritional support; 4) mechanical ventilation >48 h. Number of recruiting centers: 2 1) Hemodynamic instability; 2) renal disease; 3) hepatic failure; 4) allergies to albumin or furosemide; 5) age <18 or >80 years; 6) pregnancy; 7) serum sodium; >150 meq/L or potassium <2.5 meq/L Albumin 25%, 25 g every 8 h (100 ml) for 5 days + furosemide continuous infusion titration total albumin dosage: 400 g (1,600 ml) Saline 100 ml every 8 hr for 5 days + 0.9% saline continuous infusion Change in body weight Oxygenation; 30-day mortality; net fluid balance
Martin [28] (n = 40) 1) The American-European Consensus Conference definition for ALI [14]; 2) serum total protein level of 6.0 g/Dl; 3) ongoing nutritional support; 4) mechanical ventilation >24 h; 3) ongoing nutritional support; 4) mechanical ventilation >24 h. Number of recruiting centers: 4 1) Hemodynamic instability; 2) renal disease; 3) clinically documented cirrhosis; 4) allergies to albumin or furosemide; 5) age <18 or >80 years; 6) pregnancy; 7) serum sodium >155 meq/L or potassium of <2.5 meq/L Albumin 25%, 25 g every 8 h for 3 days; furosemide continuous infusion titration total albumin dosage: 250 g (1,000 ml) Saline 0.9% (100 ml) every 8 h for 3 days furosemide continuous infusion titration (1 mg/ml) Change in oxygenation after 24 h Net fluid balance; 30-day mortality; serum albumin; serum creatinine
SAFE [30] ARDS subgroup (n = 127) 1) Need for additional fluid resuscitation additional to intravenous fluid that was required for nutrition or to replace ongoing insensible losses, urinary losses, ongoing losses from other sites; 2) 4% human albumin solution and 0.9% sodium chloride were equally appropriate for the patient judged by treating physician; 3) requirement for fluid resuscitation must have been supported by at least one of the following clinical signs: a. HR >90 bpm; b. SBP <100 mmHg or MAP <75 mmHg or a 40 mmHg decrease in SBP or MAP from the baseline recording, or requirement for inotropes or vasopressors; c. CVP <10 mmHg; d. PCWP <12 mmHg; e. respiratory variation in systolic or mean arterial blood pressure >5 mmHg; f. capillary refill time >1 s; g. UOP <0.5 mL/kg for 1 h. Number of recruiting centers: 16 1) Adverse reaction to albumin; 2) religious objection to the administration of human blood products; 3) plasmapheresis during the ICU admission; 4) cardiac surgical patients; 5) patients with burns; 6) liver transplantation; 7) age <18 years; 8) brain dead; 9) low expectation of survival <24 h, not-to-be-resuscitated patients; 10) previous enrollment in the SAFE study; 11) previously received fluid resuscitation during current ICU or hospital admission; 12) previously received fluid resuscitation from transferring non-study ICU Albumin 4% for all fluid resuscitation until ICU discharge, or death, or day 28; adaptive regime according to clinical status; total albumin dosage: not reported Saline 0.9% for all fluid resuscitation during ICU discharge or death or until day 28; adaptive regime according to clinical status 28-day mortality None reported for ARDS subgroup
  1. ARDS, acute respiratory distress syndrome; ALI, acute lung injury; CVP, central venous pressure; HR, heart rate; MAP, mean arterial pressure; PCWP, pulmonary capillary wedge pressure; SAFE: saline versus albumin fluid evaluation; SBP, systolic blood pressure; UOP, urine output.