Evidence map›Paper›PMID 19583868›Full record

Trial reportTrials2009

Intravenous fluid restriction after major abdominal surgery: a randomized blinded clinical trial.

Hester Vermeulen, Jan Hofland, Dink A Legemate, Dirk T Ubbink

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 3 pooled it
6.8field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 3 syntheses or guidelines pooled it, 88 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Article
  10. Article
  11. Review
  12. Review
  13. Article
  14. Impact of Intravenous Fluids and Enteral Nutrition on the Severity of Gastrointestinal Dysfunction: A Systematic Review and Meta-analysis.Journal of critical care medicine (Universitatea de Medicina si Farmacie din Targu-Mures) · 2020
    Article
  15. Review
  16. Article
  17. [Intraoperative surgical and anesthesiological problems and the consequences for surgery].Der Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen · 2012
    Article
  18. Fluid overload at initiation of renal replacement therapy is associated with lack of renal recovery in patients with acute kidney injury.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2012
    Article
  19. Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 3 institutions in 1 country.

Hester VermeulenDepartment of Quality Assurance & Process Innovation, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands. h.vermeulen@amc.uva.nl
Jan Hofland
Dink A Legemate
Dirk T Ubbink
University of Amsterdam · NLAcademic Medical Center · NLErasmus MC · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

AbdomenAdultAgedFemaleFluid TherapyFollow-Up StudiesHumansInfusions, IntravenousIsotonic SolutionsLength of StayMaleMedical AuditMiddle AgedPostoperative CarePostoperative ComplicationsStomachIsotonic Solutions

Identifiers

PMID19583868
PMCPMC2717956
OpenAlexW2138086225

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.