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

Completed

Conditions: Eligible patients for participation in this clinical trial are those planned to undergo elective pancreatico-duodenectomy

Registration Number: NL-OMON21304

Lead Sponsor: Academic Medical Center Amsterdam (AMC)

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

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.

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
The secondary endpoints are the following:<br>1. Total amount used of: furosemide, (no prior usage);<br>2. Total amount used intra-operatively of: noradrenalin;<br>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;<br>4. Albumin levels: day 1, 3 and 7 postoperatively;<br>5. Nutritional intake (calculation by dietician);<br>6. Duration of hospital stay;<br>7. The length of remaining duodenum will be measured during operation (distance between pylorus and duodeno-jejunostomy).