Effects of Peri-Operative fluid Restriction in patients undergoing pancreatic surgery

ISRCTN	ISRCTN62621488
DOI	https://doi.org/10.1186/ISRCTN62621488
Protocol serial number	NTR573
Sponsor	Academic Medical Center (AMC) (Netherlands)
Funder	Academic Medical Center (AMC) (Netherlands)

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 of protocol

Not provided at time of registration

Contact information

Dr G. Samkar, van
Scientific

Academic Medical Center (AMC)
Department of Anesthesiology
H1- 128
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Study information

Primary study design	Interventional
Study design	Randomised, double blind, active controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title	Effects of Peri-Operative fluid Restriction in patients undergoing pancreatic surgery
Study acronym	EPOR trial
Study objectives	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
Health condition(s) or problem(s) studied	Pancreatic cancer
Intervention	Restrictive peri-operative fluid management versus standardised peri-operative fluid management in Whipple surgery.
Intervention type	Other
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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)
Completion date	31/12/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	50
Key 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
Key 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
Date of first enrolment	01/03/2006
Date of final enrolment	31/12/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

Academic Medical Center (AMC)

Amsterdam
1100 DD
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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.