Bechir 2013.

Methods	RCT Parallel design Single centre
Participants	Total number of randomised participants: 48 Inclusion criteria: ≥ 16 years of age with second‐ or third‐degree acute burn injuries and > 15% of body surface area burned Exclusion criteria: expected to die within 24‐36 h (i.e. burn victims with whole body burn trauma); in situations of palliative care; pregnancy; lack of informed consent; known allergy to HES; contraindications for balanced 6% HES 130/0.04; intracerebral bleeding; acute renal failure; severe hypernatraemia and other severe electrolyte disorders; severe von Willebrand Syndrome; acute liver failure Participant condition: burns; TBSA > 15% Baseline characteristics Colloids group Age, median (IQR): 49 (22‐69) years Gender, M:F: 17:6 Weight, median (IQR): 75 (70‐83) kg BP, median (IQR): SBP: 109 (93‐130); DBP: 60 (55‐65) mmHg TBSA, median burned (IQR): 31% (21‐47) Crystalloids group Age, median (IQR): 47 (26‐61) years Gender, M:F: 17:5 Weight, median (IQR): 80 (70‐80) kg BP, median (IQR): SBP: 123 (104‐150) mmHg; DBP: 68 (59‐76) mmHg TBSA, median burned (IQR): 32% (20%‐50%) Country: Switzerland Setting: tertiary burns unit
Interventions	Colloids group Participants: n = 24; losses = 0; analysed = 24 Details: 6% HES 130/0.4; 500 mL; each participant first received 2 bags of unblinded RL solution (500 mL each bag); after each bag of study solution, all participants again received 2 bags of unblinded RL solution, before a next bag of study solution from the blinded box was infused; maximum to be given as 50 mL/kg/24 h Additional details: fluid was administered until target variables were met; 2 bags of unblinded RL (500 mL each bag); then 1 bag of HES; then 2 bags of unblinded RL Crystalloids group Participants: n = 24; losses = 0; analysed = 24 Details: RL solution; 500 mL; each participant first received 2 bags of unblinded RL solution (500 mL each bag); after each bag of study solution, all participants again received 2 bags of unblinded RL solution, before a next bag of study solution from the blinded box was infused Additional details: as for colloids group but given RL in blinded bags in between unblinded bags
Outcomes	Outcomes measured/reported: group difference in administration of fluid with 72 h; creatinine levels; urine output; ARDS; LoS in ICU; LoS in hospital; in‐hospital mortality and at 28 days; post‐hoc 90‐day mortality; RRT Outcomes relevant to the review: mortality (28 days; and 90 days); RRT (collected as a 90‐day post‐hoc analysis)
Notes	Funding/declarations of interest: funding from manufacturer of HES, which supplied study fluids; 2 of the authors have vocationally been members of advisory board meetings. No competing interests declared. Funders reported as having no input in study design and interpretation of results Study dates: November 2009‐January 2013
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation completed using minimisation technique, conducted by a third party
Allocation concealment (selection bias)	Low risk	A third party not involved in conduction of study, performed the randomisation process
Blinding of participants and personnel (performance bias): mortality	Low risk	All personnel blinded. Fluids prepared externally, and concealed in bags of black plastic
Blinding of participants and personnel (performance bias): transfusion/renal replacement therapy/adverse events	Low risk	All personnel blinded. Fluids prepared externally, and concealed in bags of black plastic
Blinding of outcome assessment (detection bias): mortality	Low risk	No details in study report. However, trial registration report states that outcome assessors were blinded
Blinding of outcome assessment (detection bias): transfusion/renal replacement therapy/adverse events	Low risk	No details in study report. However, trial registration report states that outcome assessors were blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	2 participants were retrospectively excluded because of meeting exclusion criteria. Data missing from 1 additional participant because of early discharge. Overall, < 10% dropout/exclusion; data reported for 45/48 randomised participants
Selective reporting (reporting bias)	High risk	Prospective clinical trials registration (NCT01012648). Only primary outcome (fluid volume administered) was listed on the trial registration site
Baseline characteristics	Low risk	Baseline characteristics comparable
Other bias	Low risk	No other sources of bias identified