Intravenous fluid restriction after major abdominal surgery: a randomized blinded clinical trial.
BACKGROUND
Intravenous (IV) fluid administration is an essential part of postoperative care. Some studies suggest that a restricted post-operative fluid regime reduces complications and postoperative hospital stay after surgery. We investigated the effects of postoperative fluid restriction in surgical patients undergoing major abdominal surgery.


METHODS
In a blinded randomized trial, 62 patients (ASA I-III) undergoing elective major abdominal surgical procedures in a university hospital were allocated either to a restricted (1.5 L/24 h) or a standard postoperative IV fluid regime (2.5 L/24 h). Primary endpoint was length of postoperative hospital stay (PHS). Secondary endpoints included postoperative complications and time to restore gastric functions.


RESULTS
After a 1-year inclusion period, an unplanned interim analysis was made because of many protocol violations due to patient deterioration. In the group with the restricted regime we found a significantly increased PHS (12.3 vs. 8.3 days; p = 0.049) and significantly more major complications: 12 in 30 (40%) vs. 5 in 32 (16%) patients (Absolute Risk Increase: 0.24 [95%CI: 0.03 to 0.46], i.e. a number needed to harm of 4 [95%CI: 2-33]). Therefore, the trial was stopped prematurely. Intention to treat analysis showed no differences in time to restore gastric functions between the groups.


CONCLUSIONS
Restricted postoperative IV fluid management, as performed in this trial, in patients undergoing major abdominal surgery appears harmful as it is accompanied by an increased risk of major postoperative complications and a prolonged postoperative hospital stay.


BACKGROUND
Current Controlled Trials ISRCTN16719551.
Vermeulen
Hester
H
Department of Quality Assurance & Process Innovation, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands. h.vermeulen@amc.uva.nl
Hofland
Jan
J
Legemate
Dink A
DA
Ubbink
Dirk T
DT
D000005:Abdomen / Q000601:surgery; D000328:Adult; D000368:Aged; D005260:Female; D005440:Fluid Therapy / Q000009:adverse effects / Q000379:methods; D005500:Follow-Up Studies; D006801:Humans; D007262:Infusions, Intravenous / Q000009:adverse effects* / Q000379:methods*; D007552:Isotonic Solutions / Q000627:therapeutic use; D007902:Length of Stay; D008297:Male; D008485:Medical Audit; D008875:Middle Aged; D011182:Postoperative Care / Q000379:methods*; D011183:Postoperative Complications / Q000209:etiology* / Q000517:prevention & control*; D013270:Stomach / Q000502:physiology; D014883:Water-Electrolyte Imbalance / Q000209:etiology
D007552:Isotonic Solutions