Intravenous fluid restriction after major abdominal surgery: a randomized blinded clinical trialReport as inadecuate




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Trials

, 10:50

First Online: 07 July 2009Received: 30 October 2008Accepted: 07 July 2009DOI: 10.1186-1745-6215-10-50

Cite this article as: Vermeulen, H., Hofland, J., Legemate, D.A. et al. Trials 2009 10: 50. doi:10.1186-1745-6215-10-50

Abstract

BackgroundIntravenous 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.

MethodsIn 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.

ResultsAfter 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.

ConclusionRestricted 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.

Trial registrationCurrent Controlled Trials ISRCTN16719551

AbbreviationsARRAbsolute Risk Reduction

ASAAmerican Standards Association

BMIBody Mass Index

CCSCanadian Cardiovascular Society

CIConfidence Interval

HAESHydroxyaethyl Starch

HbHemoglobin

IQRInter Quartile Range

IVIntraVenously

MAPMean Arterial blood Pressure

NYHANew York Heart Association

PHSPostoperative Hospital Stay

PRCPacked Red Cells

RFRRestricted Fluid Regime

SDStandard Deviation

SFRStandard Fluid Regime

SPSSStatistical Package for the Social Sciences.

Electronic supplementary materialThe online version of this article doi:10.1186-1745-6215-10-50 contains supplementary material, which is available to authorized users.

Jan Hofland, Dink A Legemate and Dirk T Ubbink contributed equally to this work.

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Author: Hester Vermeulen - Jan Hofland - Dink A Legemate - Dirk T Ubbink

Source: https://link.springer.com/







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