Summary of findings for the main comparison. Perioperative restrictive fluid therapy compared with goal‐directed fluid therapy for adults undergoing major non‐cardiac surgery.
| Perioperative restrictive fluid therapy compared with goal‐directed fluid therapy for adults undergoing major non‐cardiac surgery | ||||||
|
Population: adults receiving intravenous fluids while undergoing major non‐cardiac surgery Settings: major non‐cardiac surgery in hospitals in Europe, Australia, New Zealand, or China Intervention: restrictive fluid therapy Comparison: goal‐directed fluid therapy | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No. of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Assumed risk1 | Corresponding risk | |||||
| GDFT | RFT | |||||
|
Major complications (during longest follow‐up period ‐ 30 days after surgery) |
Lower‐risk population | RR 1.61 (0.78 to 3.34) | 484 (5) | ⊕⊝⊝⊝ Very lowa | ||
| 20 per 1000 | 32 per 1000 (16 to 67) | |||||
| Medium‐risk population | ||||||
| 105 per 1000 | 169 per 1000 (82 to 351) | |||||
| Higher‐risk population | ||||||
| 189 per 1000 | 304 per 1000 (147 to 631) | |||||
|
All‐cause mortality (during longest follow‐up period ‐ 30 days after surgery or until discharge) |
14 per 1000 | 68 per 1000 (20 to 238) | RD 0.03 (0.00 to 0.06) | 544 (6) | ⊕⊝⊝⊝ Very lowb | Peto OR 4.81 (1.38 to 16.84) |
|
Length of hospital stay (days) |
Mean length of stay ranged across control groups from 6.67 to 10.7 days | Mean length of stay in the intervention groups was 0.02 days less (0.55 days lower to 0.5 days higher) | MD ‐0.02 (‐0.55 to 0.50) | 464 (5) | ⊕⊝⊝⊝ Very lowc | |
|
Surgery‐related complications
(during longest follow‐up period ‐ 30 days after surgery or until discharge) |
Lower‐risk population | RR 1.54 (0.87 to 2.72) | 364 (4) | ⊕⊝⊝⊝ Very lowd | Surgery‐related complications were defined as tissue‐healing complications in one study; major abdominal complications in one study; surgical complications in one study (including intra‐abdominal collections, anastomotic leak, wound infection, and ileus); and surgical site infection or bowel obstruction in one study | |
| 50 per 1000 | 77 per 1000 (44 to 136) | |||||
| Medium‐risk population | ||||||
| 113 per 1000 | 174 per 1000 (99 to 307) | |||||
| Higher‐risk population | ||||||
| 378 per 1000 | 582 per 1000 (329 to 1028) | |||||
|
Non‐surgery‐related complications (during longest follow‐up period ‐ 30 days after surgery) |
324 per 1000 | 324 per 1000 (169 to 625) | RR 1.00 (0.52 to 1.93) | 74 (1) | ⊕⊝⊝⊝ Very lowe | Non‐surgery‐related complications included cardiorespiratory, urinary, haemorrhage, and other complications |
|
Renal failure (during longest follow‐up period ‐ 30 days after surgery) |
Lower‐risk population | RR 1.38 (0.57 to 3.36) | 410 (4) | ⊕⊝⊝⊝ Very lowf | ||
| 13 per 1000 | 18 per 1000 (7 to 44) | |||||
| Higher‐risk population | ||||||
| 125 per 1000 | 173 per 1000 (71 to 420) | |||||
|
Quality of surgical recovery assessed in any way (e.g. as a surgical recovery score) (during longest follow‐up period ‐ 30 days after surgery) |
Data presented only on a graph in the study | 74 (1) |
⊕⊝⊝⊝ Very lowg | Study authors reported no difference in SRS between RFT and GDFT groups at any point (day 1, 3, 7, 14, or 30) | ||
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; GDFT: goal‐directed fluid therapy; MD: mean difference; OR: odds ratio; RD: risk difference; RFT: restrictive fluid therapy; RR: risk ratio. | ||||||
| GRADE Working Group grades of evidence. High certainty: further research is very unlikely to change our confidence in the estimate of effect. Moderate certainty: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low certainty: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low certainty: we are very uncertain about the estimate. | ||||||
aDowngraded one level for study limitations (two studies were judged at high risk of bias in the incomplete outcome data domain; 'worst‐case scenario' analysis for missing data influenced the results), one level for imprecision of results (optimal information size not met, small number of events, wide confidence intervals), and one level for indirectness of evidence (most studies were performed on abdominal surgery, most included participants were ASA II, RFT protocols were imprecise).
bDowngraded one level for study limitations (two studies were judged at high risk of bias in the incomplete outcome data domain; 'worst‐case scenario' analysis for missing data influenced the results), one level for indirectness of evidence (most studies were performed on abdominal surgery, most included participants were ASA II, RFT protocols were imprecise), and one level for imprecision of results (optimal information size not met, small number of events, wide confidence intervals).
cDowngraded one level for study limitations (one study was judged at high risk of bias in the blinding of participants and personnel domain, one study at unclear risk of bias in the blinding of participants and personnel domain, and one study at high risk of bias in incomplete outcome data) and one level for indirectness of evidence (most studies were on abdominal surgery, most included participants were ASA II, RFT protocols were imprecise), and one level forimprecision of results (optimal information size not met, confidence intervals crossing the line of no effect and including both benefit and harm).
dDowngraded one level for study limitations (two studies were judged at high risk of bias in blinding of participants and personnel domain, one study at unclear risk of bias in blinding of participants and personnel domain, and two studies at high risk of bias in Incomplete outcome data domain); one level for imprecision of results (optimal information size not met, small number of events, wide confidence intervals crossing the line of no effect and including both benefit and harm); and one level for indirectness of evidence (most studies were on abdominal surgery, most included participants were ASA II, RFT protocols were imprecise).
eDowngraded one level forstudy limitations in the included study (judged at high risk of bias in Incomplete outcome data domain) and one level for indirectness of evidence (included study was performed on abdominal surgery, most included participants were ASA II, RFT protocol was imprecise), and one level for imprecision of results (optimal information size not met ‐ single study with small number of participants and few events, wide confidence intervals crossing the line of no effect, and including both benefit and harm).
fDowngraded one level for study limitations (one study was judged at high risk of bias in blinding of participants and personnel domain, and one study at unclear risk of bias in blinding of participants and personnel domain); one level for indirectness of evidence (most studies were on abdominal surgery, most included participants were ASA II, RFT protocols were imprecise); and one level for imprecision of results (optimal information size not met, small number of events, wide confidence intervals crossing the line of no effect and including both benefit and harm).
gDowngraded one level for study limitations in the included study (one study judged at high risk of bias in incomplete outcome data domain); one level for indirectness of evidence (included study was performed on abdominal surgery, most included participants were ASA II, RFT protocol was imprecise); and one level for imprecision of results (optimal information size not met ‐ single study with small number of participants and few events).1Based on population risk in the included studies.