Wills 2005.
Methods | RCT Parallel design Single centre |
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Participants |
Total number of randomised participants: 383 Inclusion criteria: 2‐15 years of age; presenting directly to the hospital with clinical DSS; parent or guardian provided consent Exclusion criteria: not reported Participant condition: DSS Baseline characteristics Colloids group (dextran)
Colloids group (HES)
Crystalloids group
Country: Vietnam Setting: paediatric ICU |
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Interventions |
Colloids group (dextran)
Colloids group (HES)
Crystalloids group
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Outcomes |
Outcomes measured/reported: requirement for supplemental intervention with rescue colloid; time taken to achieve initial and sustained cardiovascular stability; pattern of change in haematocrit; days in hospital; adverse effects (including need for blood transfusion, rashes), mortality Outcomes relevant to the review: need for transfusion of a blood product; mortality (time point not reported); adverse events (rashes) |
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Notes |
Funding/declarations of interest: supported by the Wellcome Trust Study dates: August 1999‐March 2004 Note: this study included a separate arm comparing two colloids for participants with severe shock (pulse pressure, ≤ 10 mm Hg); we did not include these participants because colloids were not compared with a crystalloid |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Use of computer‐generated random numbers completed by independent research staff |
Allocation concealment (selection bias) | Low risk | Allocation concealed through treatment packs of fluid prepared in advance, in cardboard containers, and only identifiable by a study number |
Blinding of participants and personnel (performance bias): mortality | Low risk | Treatment packs of fluid were prepared in advance, in cardboard containers, and only identifiable by a study number |
Blinding of participants and personnel (performance bias): transfusion/renal replacement therapy/adverse events | Low risk | Treatment packs of fluid were prepared in advance, in cardboard containers, and only identifiable by a study number |
Blinding of outcome assessment (detection bias): mortality | Low risk | No details of blinding for assessment of mortality; lack of blinding unlikely to influence data for this outcome |
Blinding of outcome assessment (detection bias): transfusion/renal replacement therapy/adverse events | Low risk | Blinding reported for assessment of other outcomes, and we assumed that assessment of transfusion data was also blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No 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 appear comparable |
Other bias | High risk | 31% participants in the crystalloid group were also given colloids and this may have influenced study results |