A Study Comparing Restrictive and Liberal Fluid Therapy During Pancreatecoduodenectomy Surgery

NCT ID: NCT07072897

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2021-08-31

Brief Summary

ancreaticoduodenectomy (also known as PD or the Whipple procedure) is a major surgery often done for conditions like pancreatic cancer. Over the past few decades, doctors around the world have greatly improved surgical techniques, reducing the risk of death after PD from about 24% in the 1980s to less than 2% today in good volume hospitals.

However, even though fewer patients are dying from the surgery, many still face complications after surgery, such as infections, delayed healing, or other problems called as morbidities. These problems can affect 17% to 50% of patients.

One important factor that may affect recovery is fluid management - the amount of fluids patients receive around the time of surgery.

Traditionally, surgeons gave large amounts of fluid during and after surgery, thinking it helped keep blood pressure and urine output stable. This approach is called liberal fluid therapy. But giving too much fluid can cause swelling, weight gain, and slower recovery.

A newer method, called restrictive fluid therapy, gives smaller, more controlled amounts of fluid to avoid these problems. This approach is new and has shown good results in some studies however the exact role is yet unclear.

At our hospital, we usually use liberal fluid therapy and give fluids based on the treating physician, using these fluids or restricting them as per the treating physician's choice.

So, the study compares these two fluid strategies in patients having PD. Our goal is to find out whether using less fluid (restrictive therapy) could help reduce complications and improve patient outcomes when compared to using more liberal fluids.

Conditions

Pancreatic Cancer, Resected; Whipple Procedure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

restrictive fluid therapy

Restrictive fluid therapy given as bolus of 5ml/kg/hr and the same amount of fluid (5ml/kg/hr) was continued as intraoperative requirement till the end of surgery. Fluid in the restrictive group given postoperatively at the rate of 1ml/kg/hr. This fluid to be given till the 24 hours of the start of surgery which was the study period for this trial. Treating physician was more inclined towards the use of noradrenaline for the maintenance of BP if the urine output was adequate (\>0.5ml/kg/hr).

Group Type: EXPERIMENTAL

Fluid bolus administration

Intervention Type: OTHER

fluid boluses 250 ml were given when required

liberal fluid therapy

In the liberal fluid therapy arm, intraoperatively the patients receive a fixed dose of fluid with a bolus of 10ml/kg/hr followed by 10ml/kg/hr till the completion of surgery. The patients receive fluid at the rate of 1.5ml/kg/hr in the postoperative period until 24 hours of the start of surgery.

Fluid boluses of 250ml each to be given anytime during the study period to overcome hypotension or oliguria (<0.5ml/kg/hr) if felt necessary by the physician.

Furosemide 10mg given intravenously anytime if the clinician was suspicious of fluid overload during the study period.

Group Type: ACTIVE_COMPARATOR

Frusemide was given when required

Intervention Type: OTHER

fluid is given in a fixed regimen

Interventions

Fluid bolus administration

fluid boluses 250 ml were given when required

Intervention Type: OTHER

Frusemide was given when required

fluid is given in a fixed regimen

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• All patients who underwent PD at TUTH during the research duration.
• All patients above 18 years.

Exclusion Criteria

• Those not willing to participate in the study.
• All patients with age ≥ 75 years.
• Patients with Chronic renal failure.
• Patients with major Cardiac illness.
• Patients who died within 24 hours of surgery.
• Failure to comply with the regimen due to any reason.
• Those who underwent palliative procedure instead of planned PD.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tribhuvan University Teaching Hospital, Institute Of Medicine.

OTHER

Sponsor Role: lead

Responsible Party

Romi Dahal

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tribhuvan University Teaching Hospital

Kathmandu, Bagmati, Nepal

Countries

Nepal

References

Myles P, Bellomo R, Corcoran T, Forbes A, Wallace S, Peyton P, Christophi C, Story D, Leslie K, Serpell J, McGuinness S, Parke R; Australian and New Zealand College of Anaesthetists Clinical Trials Network, and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Restrictive versus liberal fluid therapy in major abdominal surgery (RELIEF): rationale and design for a multicentre randomised trial. BMJ Open. 2017 Mar 3;7(3):e015358. doi: 10.1136/bmjopen-2016-015358.

Reference Type: BACKGROUND

PMID: 28259855 (View on PubMed)

Related Links

https://pubmed.ncbi.nlm.nih.gov/36688507

Peer-reviewed publication related to the study rationale and background

Other Identifiers

Nepalhealthresearchcouncil2379

Identifier Type: -

Identifier Source: org_study_id