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Effects of Per-Operative fluid Restriction in patients undergoing pancreatic surgery.


- candidate number1945
- NTR NumberNTR573
- ISRCTNISRCTN62621488
- Date ISRCTN created14-feb-2006
- date ISRCTN requested13-feb-2006
- Date Registered NTR27-jan-2006
- Secondary IDsN/A 
- Public TitleEffects of Per-Operative fluid Restriction in patients undergoing pancreatic surgery.
- Scientific TitleA Randomised controlled trial on gastric motility effects induced by fluid restriction in patients undergoing elective pancreatic surgery.
- ACRONYMEPOR trial
- hypothesisOur hypothesis is that peroperative fluid restriction will lead to a significant reduction of solid phase gastric emptying time ¨C measured by radionuclide scintigraphy-, and a reduction in its related postoperative complications.
- Healt Condition(s) or Problem(s) studiedPancreatic cancer
- Inclusion criteria1. Age range ¡Ý 18 years; 2. Male patients, or female patients of non childbearing potential or with adequate contraception; 3. ASA classification I ¨C IV; 4. Patients who will undergo elective pancreatic surgery; 5. Written informed consent.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type[default]
- Studytypeintervention
- planned startdate 1-mrt-2006
- planned closingdate16-mrt-2009
- Target number of participants50
- InterventionsRestrictive peroperative fluid management and standardised peroperative fluid management in Whipple surgery.
- Primary outcomeThe 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 outcomeThe 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 vs. day 1, 3 and 7 postoperatively; 4. Albumin levels: day 1, 3 and 7 postoperatively; 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).
- Timepoints
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD. G. Samkar, van
- CONTACT for SCIENTIFIC QUERIESMD. Dr. PhD. J. Hofland
- Sponsor/Initiator Academic Medical Center (AMC, Amsterdam)
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryStudies have shown that large volume infusions, especially when given during major surgical procedures, influence the outcome of these operations. There is evidence supporting the view that fluid restriction has a beneficial effect on several parameters. AIM: Our primary aim is to ascertain whether the gastric emptying time can be improved by a peroperative restrictive fluid regime. Our secondary aim is to see whether there is any difference between the two groups in: use of furosemide, noradrenaline, postoperative renal function, food intake and duration of hospital stay. Patients and Methods: Eligible patients will be randomised, and will be treated during the operation with a restrictive or standard fluid regime. They will undergo a gastric emptying scan 1 day preoperatively, and also 7 days postoperatively, after ingesting a standardised test meal.
- Main changes (audit trail)
- RECORD27-jan-2006 - 19-mrt-2009


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