Introduction
Methods
Study type and registration
Identification of relevant studies
Eligibility criteria
Trial selection and data abstraction
Risk of bias assessment and strength of evidence
Data synthesis
Results
Trial identification
Trial characteristics
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 |
Risk of bias
Trial | Sequence generation | Allocation concealment | Blinding of participants, personnel and outcome assessors | Incomplete outcome data | Selective outcome reporting | Other bias | Overall risk of bias |
---|---|---|---|---|---|---|---|
Martin [29] | Low | Low | Low | Low | Unclear | High* | High* |
Martin [28] | Low | Low | Low | Low | Unclear | Low | Unclear |
SAFE [30] | Unclear | Low | Low | Low | Unclear | Low | Unclear |
Mortality
Oxygenation
Discussion
Conclusion
Key messages
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Only three trials have compared colloid therapy to crystalloid therapy in ARDS patients.
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All these trials compared albumin to saline.
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Combined results of these studies showed no effect of albumin therapy on mortality, but showed an improvement in oxygenation.
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Given the small sample size and limited data on outcome, potential benefits of albumin solutions in ARDS patients remain uncertain.