Condition category
Surgery
Date applied
28/04/2006
Date assigned
28/04/2006
Last edited
13/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr H. Vermeulen

ORCID ID

Contact details

Academic Medical Center (AMC)
Department of Surgery
G4-233
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
H.Vermeulen@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

A restrictive fluid regimen is beneficial for postoperative recovery after abdominal surgery, as to hospital stay and postoperative complications.

Ethics approval

Received from the local medical ethics committee

Study design

Randomised triple-blinded clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Abdominal surgery

Intervention

1.5 l intravenous fluid/24 hours versus 2.5 l/24 hours.
Trial was stopped prematurely because of protocol violations due to patient deterioration, with significantly increased postoperative hospital stay (12.3 vs. 8.3 days; p=0.049) and significantly more major complications (12 in 30 (40%) vs. 5 in 32 (16%) patients) in the group with the restricted regime. (detailed in pub 07/07/09)

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Length of hospital stay.

Secondary outcome measures

1. Postoperative complications
2. Time to restoration of gastric functions and normal diet

Overall trial start date

01/05/2004

Overall trial end date

01/07/2005

Reason abandoned

Objectives no longer viable

Eligibility

Participant inclusion criteria

1. Abdominal surgery
2. Age >18
3. American Society of Anesthesiologists (ASA) I-III
4. Understanding the Dutch language
5. Signed informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Cardiac diseases (New York Hearth Association [NYHA] >III and CCS >III)
2. Contraindications for epidural analgesia
3. Presence of diabetes mellitus
4. Planned for liver or oesophageal surgery
5. Participating in another trial
6. Anticipated postoperative stay in the Intensive Care Unit

Recruitment start date

01/05/2004

Recruitment end date

01/07/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Center (AMC), Department of Surgery (Netherlands)

Sponsor details

P.O. Box 22660
Amsterdam
1105 AZ
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Center for Clinical Practice Guidelines, Academic Medical Center (AMC) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Dutch Health Care Insurance Board (CVZ, independent government organisation) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19583868

Publication citations

  1. Results

    Vermeulen H, Hofland J, Legemate DA, Ubbink DT, Intravenous fluid restriction after major abdominal surgery: a randomized blinded clinical trial., Trials, 2009, 10, 50, doi: 10.1186/1745-6215-10-50.

Additional files

Editorial Notes