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

Van der Heijden 2009.

Methods RCT
Parallel design
Single centre
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)
  • Age, median (range): 57 (22‐75) years

  • Gender, M:F: 9:3

  • APACHE II, median (range): 12 (6‐23)


Colloids group (albumin)
  • Age, median (range): 61 (39‐77) years

  • Gender, M:F: 8:4

  • APACHE II, median (range): 15 (5‐18)


Colloids group (gelatin)
  • Age, median (range): 61 (27‐74) years

  • Gender, M:F: 9:3

  • APACHE II, median (range): 10 (4‐20)


Crystalloids group
  • Age, median (range): 62 (25‐77) years

  • Gender, M:F: 9:3

  • APACHE II, median (range): 10 (6‐23)


Country: the Netherlands
Setting: hospital
Interventions Colloids group (HES)
  • Participants: n = 12; losses = 0; analysed = 12

  • Details: 6% HES 200/0.45‐0.55

  • Additional details: fluids given during 90 min on basis of response to predefined pressure limits and CVP, according to a protocol; boluses at maximum of 200 mL/10 min, so that maximum fluid challenge was 1800 mL in 90 min


Colloids group (albumin)
  • Participants: n = 12; losses = 0; analysed = 12

  • Details: albumin 5%; 100 mL Cealb 20%; diluted in 300 mL of saline

  • Additional details: same as colloids group (HES)


Colloids group (gelatin)
  • Participants: n = 12; losses = 0; analysed = 12

  • Details: 4% Gelofusine 40 g/L; in 154/120 mM NaCl

  • Additional details: same as colloids group (HES)


Crystalloids group
  • Participants: n = 12; losses = 0; analysed = 12

  • Details: 0.9% (assume NS)

  • Additional details: same as colloids group (HES)

Outcomes Outcomes measured/reported: haemodynamic variables; respiratory variables; mortality
Outcomes relevant to the review: mortality (until discharge from the ICU)
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
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