Our 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.
ID
Bron
Verkorte titel
Aandoening
Eligible patients for participation in this clinical trial are those planned to undergo elective pancreatico-duodenectomy
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
Studies 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.
Doel van het onderzoek
Our 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.
Onderzoeksproduct en/of interventie
Restrictive peroperative fluid management and standardised peroperative fluid management in Whipple surgery.
Publiek
P.O. Box 22660
G. Samkar, van
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5669111
Wetenschappelijk
P.O. Box 22660
G. Samkar, van
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5669111
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL529 |
| NTR-old | NTR573 |
| Ander register | : N/A |
| ISRCTN | ISRCTN62621488 |