Effect of intravenous fluid restriction on hospital stay and complications after abdominal surgery: a randomised triple-blinded clinical trial
| ISRCTN | ISRCTN16719551 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16719551 |
| Protocol serial number | N/A |
| Sponsor | Academic Medical Center (AMC), Department of Surgery (Netherlands) |
| Funders | Center for Clinical Practice Guidelines, Academic Medical Center (AMC) (Netherlands), Dutch Health Care Insurance Board (CVZ, independent government organisation) (Netherlands) |
- Submission date
- 28/04/2006
- Registration date
- 28/04/2006
- Last edited
- 13/07/2009
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr H. Vermeulen
Scientific
Scientific
Academic Medical Center (AMC)
Department of Surgery, G4-233
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| H.Vermeulen@amc.uva.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised triple-blinded clinical trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | A restrictive fluid regimen is beneficial for postoperative recovery after abdominal surgery, as to hospital stay and postoperative complications. |
| Ethics approval(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Length of hospital stay. |
| Key secondary outcome measure(s) |
1. Postoperative complications |
| Completion date | 01/07/2005 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2004 |
| Date of final enrolment | 01/07/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 07/07/2009 | Yes | No |
