Randomized clinical trial of fluid and salt restriction compared with a controlled liberal regimen in elective gastrointestinal surgery

Br J Surg. 2013 Dec;100(13):1739-46. doi: 10.1002/bjs.9301.

Abstract

Background: Excessive intravenous fluid prescription may play a causal role in postoperative complications following major gastrointestinal resectional surgery. The aim of this study was to investigate whether fluid and salt restriction would decrease postoperative complications compared with a more modern controlled liberal regimen.

Methods: In this observer-blinded single-site randomized clinical trial consecutive patients undergoing major gastrointestinal resectional surgery were randomized to receive either a liberal control fluid regimen or a restricted fluid and salt regimen. The primary outcome was postoperative complications of grade II and above (moderate to severe).

Results: Some 240 patients (194 colorectal resections and 46 oesophagogastric resections) were enrolled in the study; 121 patients were randomized to the restricted regimen and 119 to the control (liberal) regimen. During surgery the control group received a median (interquartile range) fluid volume of 2033 (1576-2500) ml and sodium input of 282 (213-339) mmol, compared with 1000 (690-1500) ml and 142 (93-218) mmol respectively in the restricted group. There was no significant difference in major complication rate between groups (38·0 and 39·0 per cent respectively). Median (range) hospital stay was 8 (3-101) days in the controls and 8 (range 3-76) days among those who received restricted fluids. There were four in-hospital deaths in the control group and two in the restricted group. Substantial differences in weight change, serum sodium, osmolality and urine : serum osmolality ratio were observed between the groups.

Conclusion: There were no significant differences in major complication rates, length of stay and in-hospital deaths when fluid restriction was used compared with a more liberal regimen.

Registration number: ISRCTN39295230 (http://www.controlled-trials.com).

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Animals
  • Elective Surgical Procedures / methods
  • Female
  • Fluid Therapy / methods*
  • Gastrointestinal Neoplasms / surgery*
  • Humans
  • Infusions, Intravenous
  • Length of Stay / statistics & numerical data
  • Male
  • Middle Aged
  • Operative Time
  • Postoperative Complications / etiology
  • Postoperative Complications / prevention & control*
  • Prospective Studies
  • Single-Blind Method
  • Sodium Chloride / administration & dosage*
  • Treatment Outcome

Substances

  • Sodium Chloride

Associated data

  • ISRCTN/ISRCTN39295230