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Effect of intravenous fluid restriction on hospital stay and complications after abdominal surgery: a randomised triple-blinded clinical trial.


- candidate number2054
- NTR NumberNTR644
- ISRCTNISRCTN16719551
- Date ISRCTN created28-apr-2006
- date ISRCTN requested25-apr-2006
- Date Registered NTR7-apr-2006
- Secondary IDsN/A 
- Public TitleEffect of intravenous fluid restriction on hospital stay and complications after abdominal surgery: a randomised triple-blinded clinical trial.
- Scientific TitleEffect of intravenous fluid restriction on hospital stay and complications after abdominal surgery: a randomised triple-blinded clinical trial.
- ACRONYMN/A
- hypothesisA restrictive fluid regimen is beneficial for postoperative recovey after abdominal surgery, as to hospital stay and postoperative complications.
- Healt Condition(s) or Problem(s) studiedAbdominal surgery
- Inclusion criteria1. Abdominal surgery;
2. Age > 18;
3. ASA I-III;
4. Understanding the Dutch language;
5. Signed informed consent.
- Exclusion criteria1. Cardiac diseases (NYHA > III en CCS > III);
2. Contraindications for epidural analgesia;
3. Presence of diabetes mellitus;
4. Planned for liver or oesophageal surgery;
5. Participating in another trial;
and/or anticipated postoperative stay in the Intensive Care Unit.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingTriple
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2004
- planned closingdate1-jul-2005
- Target number of participants100
- Interventions1,5 litre intravenous fluid/24h vs. 2,5 litre/24h.
- Primary outcomeLength of hospital stay.
- Secondary outcome1. Postoperative complications;
2. Time to restoration of gastric functions and normal diet.
- TimepointsN/A
- Trial web siteN/A
- statusstopped
- CONTACT FOR PUBLIC QUERIES H. Vermeulen
- CONTACT for SCIENTIFIC QUERIESProf. Dr. D.A. Legemate
- Sponsor/Initiator Academic Medical Center (AMC), Department of Surgery, Academic Medical Center (AMC), Center for Clinical Practice Guidelines
- Funding
(Source(s) of Monetary or Material Support)
Dutch Health Care Insurance Board (CVZ, independent governement organisation), Center for Clinical Practice Guidelines, Academic Medical Center (AMC), Amsterdam
- PublicationsN/A
- Brief summaryBackground:
Intravenous fluid administration after abdominal surgery is an essential, but variable part of postoperative care. The optimum suppletion volume after abdominal surgery is unknown. In colorectal surgery a restrictive fluid regime was found to reduce complications. We investigated the benefits of a restrictive postoperative intravenous fluid management in patients undergoing elective abdominal surgery.


Methods:
In a triple-blinded trial we randomly allocated patients undergoing elective abdominal surgery to a restrictive postoperative regime of 1,5 litre intravenous fluid/24h vs. 2,5 litre/24h, which was standard hospital practice. Primary outcome measure was length of hospital stay (LOS), secondary measures were postoperative complications and time to restoration of gastric functions and normal diet.
- Main changes (audit trail)
- RECORD7-apr-2006 - 4-sep-2008


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