Table 5

 GRADE quality of evidence summary table for the comparisons of human albumin with control, crystalloid, or colloid fluid for adults with sepsis of any severity in critical or intensive care

Quality assessment for comparisonNo of patientsEffectQualityImportance
No of studiesDesignRisk of biasInconsistencyIndirectnessImprecisionOther considerationsHuman albuminCompared fluidRelative risk (95% CI)Absolute
Quality assessment for the comparison of human albumin with control fluid
All-cause mortality (follow-up ICU discharge to 90 days observation):
16RCTSerious*No serious inconsistencyNo serious indirectnessNo serious imprecisionNone757/2068 (36.6%)835/2122 (39.3%)0.94 (0.87 to 1.01)2 fewer per 100 (from 5 fewer to 0 more)+++ ModerateCritical
All-cause mortality in studies at low or unclear risk of bias (follow-up ICU discharge to 90 days observation):
6RCTNo serious riskNo serious inconsistencyNo serious indirectnessNo serious imprecisionNone699/1956 (35.7%)767/1986 (38.6%)0.93 (0.86 to 1.01)3 fewer per 100 (from 5 fewer to 0 more)++++ HighCritical
All-cause mortality in studies at high risk of bias (follow-up ICU discharge to 30 days observation):
10RCTSerious†No serious inconsistencySerious‡Serious§None58/112 (51.8%)68/136 (50%)1.02 (0.83 to 1.24)1 more per 100 (from 9 fewer to 12 more)+ Very lowCritical
Quality assessment for the comparison of human albumin with crystalloid fluid
All-cause mortality (follow-up ICU discharge to 90 days observation):
7RCTNo serious riskNo serious inconsistencyNo serious indirectnessNo serious imprecisionNone710/1937 (36.7%)763/1941 (39.3%)0.93 (0.86 to 1.01)3 fewer per 100 (from 6 fewer to 0 more)++++ HighCritical
All-cause mortality in studies at low or unclear risk of bias (follow-up ICU discharge to 90 days observation):
4RCTNo serious riskNo serious inconsistencyNo serious indirectnessNo serious imprecisionNone690/1911 (36.1%)746/1921 (38.8%)0.93 (0.86 to 1.01)3 fewer per 100 (from 5 fewer to 0 more)++++ HighCritical
All-cause mortality in studies at high risk of bias (follow-up hospital discharge observation):
3RCTSerious†No serious inconsistencyNo serious indirectnessSerious§None20/26 (76.9%)17/20 (85.0%)0.92 (0.71 to 1.20)7 fewer per 100 (from 25 fewer to 17 more)++ LowCritical
Quality assessment for the comparison of human albumin with colloid fluid
All-cause mortality (follow-up ICU discharge to 28 days observation):
11RCTSerious¶No serious inconsistencySerious‡Serious§None54/143 (37.8%)58/156 (37.2%)1.04 (0.79 to 1.38)1 more per 100 (from 8 fewer to 14 more)+ Very lowCritical
All-cause mortality in studies at low or unclear risk of bias (follow-up ICU discharge to 28 days observation):
3RCTNo serious riskNo serious inconsistencySerious‡Serious§None11/51 (21.6%)21/65 (32.3%)0.77 (0.42 to 1.43)7 fewer per 100 (from 19 fewer to 14 more)++ LowCritical
All-cause mortality in studies at high risk of bias (follow-up ICU discharge to hospital discharge observation):
8RCTSerious†No serious inconsistencySerious‡Serious§None43/92 (46.7%)37/91 (40.7%)1.13 (0.83 to 1.53)5 more per 100 (from 7 fewer to 22 more)+ Very lowCritical

ICU=intensive or critical care unit. RCT=randomised clinical trial.

*5.9% of patients were in studies judged as high risk of bias.

†All studies judged as high risk of bias.

‡Most patients were compared with high molecular weight hydroxyethyl starches that are now seldom available or used for adults with sepsis in critical or intensive care. This class of synthetic colloid has been associated with harm, and the European Medicines Agency on 6 March 2014 and the Food and Drug Administration on 25 November 2013 have concluded that hydroxyethyl starches solutions are no longer permitted for use in critically unwell adults with sepsis in parts of Europe and the US.24 25

§Wide 95% confidence intervals, most included studies are small, and the information size is low.

¶61.2% patients were in studies judged as high risk of bias.