| Methods | n = 88, 1 centre Allocation concealment: not described Baseline similarity: age (D), sepsis Blinding: caregivers Cointerventions: application of PEEP protocolized Withdrawals: 7/88 (group unclear) Losses to follow‐up: none |
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| Participants | Inclusions: Mechanical ventilation with PaO2 < 100 mmHg on FiO2 = 0.4 and PaO2 < 350 mmHg on FiO2 = 1 Exclusions: Presence of ARDS (more than one of the following: PaO2 < 250 mmHg on FiO2 = 1, pulmonary shunt > 25%, diffuse interstitial edema on CXR); immunocompromised; some infections; uncontrolled diabetes mellitus |
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| Interventions | IV methylprednisolone, 30 mg/kg IV every 6 hours for 48 hours, or placebo | |
| Outcomes | Mortality: RR 1.49 (95% CI 0.85 to 2.62), based on data from 81 patients Duration of ventilation (days): 20 (range 5 to 63) in treatment group, 18 (range 3 to 72) in placebo group Adverse events leading to discontinuation of therapy not reported Other safety information: infectious complications (treatment: 30/39 patients, control: 18/42 patients) |
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| Notes | The duration of mechanical ventilation prior to randomization was not reported. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
All included studies were randomized controlled trials. Inclusions and exclusions refer to principal selection criteria. Outcomes include those selected a priori for analysis in this review. For definition of lung injury score, see American Review of Respiratory Diesease 1988;138(3):720‐3.
Methods notes: Baseline similarity: Pre‐randomization factors assessed included age, severity of illness, non‐pulmonary organ failures, presence of sepsis, and duration of hospitalization, ICU stay, or mechanical ventilation. Factors are listed if they were clinically similar between treatment and control groups. Factors with significant clinical differences (D) between groups and included in an adjusted analysis (A) are noted. Blinding: We assessed blinding of caregivers, data collectors, and outcomes assessors and note the use of other terms. We interpreted "double‐blind" to include caregiver blinding. Cointerventions: We assessed whether the use of PEEP, a lung protective ventilation strategy, weaning protocols, corticosteroids, or other interventions were standardized or documented. Withdrawals: The number of randomized patients withdrawn from the mortality analysis. Losses to follow‐up: The number of randomized patients with incomplete follow‐up data for mortality.
Abbreviations: AECC = American‐European Consensus Conference (see Background), AIDS = acquired immunodeficiency syndrome, ALI = acute lung injury, APACHE = acute physiology and chronic health evaluation (see Critical Care Medicine 1985;13(10):818‐29 and Chest 1991;100(6):1619‐36), ARDS = acute respiratory distress syndrome, CI = confidence interval, CXR = chest radiograph, DPPC = dipalmitoylphosphatidylcholine, HIV = human immunodeficiency virus, ICU = intensive care unit, IV = intravenous, LAH = left atrial hypertension, MD = difference (mean in treatment group ‐ mean in control group), MI = myocardial infarction, MODS = multiple organ dysfunction score (see Critical Care Medicine 1995;23(10):1638‐52), n = number of randomized patients, NAC = N‐acetylcysteine, PAO2 = partial pressure of alveolar oxygen, PAOP = pulmonary artery occlusion pressure, PEEP = positive end‐expiratory pressure, P/F = ratio of partial pressure of arterial oxygen (PaO2) to fraction of oxygen in inspired gas (FiO2), PGE1=prostaglandin E1, RR = relative risk, SAPS = simplified acute physiology score (see Critical Care Medicine 1984;12(11):975‐7).