Effects of Peri-Operative fluid Restriction in patients undergoing pancreatic surgery
| ISRCTN | ISRCTN62621488 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62621488 |
| Secondary identifying numbers | NTR573 |
- Submission date
- 14/02/2006
- Registration date
- 14/02/2006
- Last edited
- 16/10/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr G. Samkar, van
Scientific
Scientific
Academic Medical Center (AMC)
Department of Anesthesiology
H1- 128
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Study information
| Study design | Randomised, double blind, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Scientific title | Effects of Peri-Operative fluid Restriction in patients undergoing pancreatic surgery |
| Study acronym | EPOR trial |
| Study hypothesis | Our hypothesis is that peri-operative fluid restriction will lead to a significant reduction of solid phase gastric emptying time measured by radionuclide scintigraphy, and a reduction in its related post-operative complications. |
| Ethics approval(s) | Received from local medical ethics committee |
| Condition | Pancreatic cancer |
| Intervention | Restrictive peri-operative fluid management versus standardised peri-operative fluid management in Whipple surgery. |
| Intervention type | Other |
| Primary outcome measure | The primary endpoint is defined as the reduction of minutes needed to achieve a 50% emptying of the stomach (T50) due to a restricted fluid infusion regime. |
| Secondary outcome measures | The secondary endpoints are the following: 1. Total amount used of furosemide (no prior usage) 2. Total amount used intra-operatively of noradrenalin 3. Blood urea and creatinine levels: a rise of more than 10% of pre-operative values measured at: pre-assessment versus day 1, 3 and 7 post-operatively 4. Albumin levels: day 1, 3 and 7 post-operatively 5. Nutritional intake (calculation by dietician) 6. Duration of hospital stay 7. The length of remaining duodenum will be measured during operation (distance between pylorus and duodeno-jejunostomy) |
| Overall study start date | 01/03/2006 |
| Overall study end date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 |
| Participant inclusion criteria | 1. Age range >18 years 2. Male patients, or female patients of non childbearing potential or with adequate contraception 3. American Society of Anesthesiologists (ASA) classification I-IV 4. Patients who will undergo elective pancreatic surgery 5. Written informed consent |
| Participant exclusion criteria | 1. Age range: <18 years 2. ASA classification V 3. Emergency operations 4. Pregnancy 5. Breast feeding period 6. Informed consent missing 7. Alcohol abuse (more than 35 units a week) 8. Drug abuse (opiates, cocaine) 9. SaO2 <90% (room atmosphere), SpO2 <8 kPa 10. Presumed non cooperatives 11. Legal incapacity 12. Refusal to undergo epidural anaesthesia 13. Dialysis or fluid restriction based on renal failure 14. Any clinical condition which does not justify study participation in the investigator's opinion |
| Recruitment start date | 01/03/2006 |
| Recruitment end date | 31/12/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Sponsor information
Academic Medical Center (AMC) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
"ROR" |
https://ror.org/03t4gr691 |
|---|
Funders
Funder type
Hospital/treatment centre
Academic Medical Center (AMC) (Netherlands)
Private sector organisation / Universities (academic only)
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Academic Medical Center, AMC
- Location
- Netherlands
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 14/10/2015 | Yes | No |
Editorial Notes
16/10/2015: Added publication reference.
