Condition category
Cancer
Date applied
14/02/2006
Date assigned
14/02/2006
Last edited
16/10/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr G. Samkar, van

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR573

Study information

Scientific title

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

Acronym

EPOR trial

Study hypothesis

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

Received from local medical ethics committee

Study design

Randomised, double blind, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Condition

Pancreatic cancer

Intervention

Restrictive peri-operative fluid management versus standardised peri-operative fluid management in Whipple surgery.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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

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)

Overall trial start date

01/03/2006

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant 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

Recruitment start date

01/03/2006

Recruitment end date

31/12/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Center (AMC) (Netherlands)

Sponsor details

P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Academic Medical Center (AMC) (Netherlands)

Alternative name(s)

Academic Medical Center, AMC

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Netherlands

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26465290

Publication citations

Additional files

Editorial Notes

16/10/2015: Added publication reference.