Van der Heijden 2009.
Methods | RCT Parallel design Single centre |
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Participants |
Total number of randomised participants: 48 Inclusion criteria: mechanically ventilated and critically ill people with clinical hypovolaemia and at risk for, or with, ALI/ARDS Exclusion criteria: > 78 years of age; pregnant; known anaphylactoid reaction to colloid fluids; life expectancy < 24 h Participant condition: clinical hypovolaemia Baseline characteristics Colloids group (HES)
Colloids group (albumin)
Colloids group (gelatin)
Crystalloids group
Country: the Netherlands Setting: hospital |
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Interventions |
Colloids group (HES)
Colloids group (albumin)
Colloids group (gelatin)
Crystalloids group
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Outcomes |
Outcomes measured/reported: haemodynamic variables; respiratory variables; mortality Outcomes relevant to the review: mortality (until discharge from the ICU) |
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Notes |
Funding/declarations of interest: supported in part by B Braun Medical, Melsungen, Germany and the Netherlands Heart Foundation, The Hague Study dates: not reported Patients stratified into septic and non‐septic. We combined these groups. Use of online supplementary information for some data |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation performed by pharmacist; no additional detail on methods used to generate codes |
Allocation concealment (selection bias) | Low risk | Used sealed envelopes prepared by pharmacist |
Blinding of participants and personnel (performance bias): mortality | Low risk | No details of blinding; unlikely to introduce bias for mortality |
Blinding of outcome assessment (detection bias): mortality | Low risk | No details of blinding; unlikely to introduce bias for mortality |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No apparent losses |
Selective reporting (reporting bias) | Unclear risk | No details of clinical trials registration or prepublished protocol; not feasible to assess risk of selective outcome reporting bias |
Baseline characteristics | Low risk | Baseline characteristics appeared comparable |
Other bias | Low risk | No other sources of bias identified |