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. 2018 Aug 3;2018(8):CD000567. doi: 10.1002/14651858.CD000567.pub7

Wills 2005.

Methods RCT
Parallel design
Single centre
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)
  • Age, median (range): 10 (6‐14) years

  • Gender, M:F: 57:69

  • Weight (median): 25 (15‐43) kg

  • BP, median (range): SBP: 90 (75‐110); DBP: 75 (57‐90) mmHg


Colloids group (HES)
  • Age, median (range): 10 (4.5‐14) years

  • Gender, M:F: 70:59

  • Weight (median): 25 (14‐40) kg

  • BP, median (range): SBP: 90 (80‐110); DBP: 75 (60‐90) mmHg


Crystalloids group
  • Age, median (range): 10 (5‐14) years

  • Gender, M:F: 66:62

  • Weight (median): 25 (15‐42) kg

  • BP, median (SD): SBP: 90 (72‐113); DBP: 75 (55‐95) mmHg


Country: Vietnam
Setting: paediatric ICU
Interventions Colloids group (dextran)
  • Participants: n = 126; losses = 0; analysed = 126

  • Details: 6% dextran, described as an isotonic colloid

  • Additional details: each participant received 15 mL/kg of body weight of allocated fluid over 1‐h period followed by 10 mL/kg over the second hour; after infusion of study fluid participants received a standard schedule of RL


Colloids group (HES)
  • Participants: n = 129; losses = 0; analysed = 129

  • Details: 6% HES, described as an isotonic colloid

  • Additional details: same as dextran group


Crystalloids group
  • Participants: n = 128; losses = 0; analysed = 128

  • Details: RL

  • Additional details: same as dextran group

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)
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
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