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

A Randomised controlled trial on gastric motility effects induced by fluid restriction in patients undergoing elective pancreatic surgery.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21304

Enrollment

Registered

2006-01-27

Start date

2006-03-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Restrictive peroperative fluid management and standardised peroperative fluid management in Whipple surgery.

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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 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).	—

Measure

Time frame

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 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).

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Contacts

Public ContactG. Samkar, van

Academic Medical Center (AMC), Department of Anesthesiology, H1- 128, P.O. Box 22660

+31 (0)20 5669111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)