Clinical trial · Interventional
Randomized Trial of Restrictive Versus Liberal Perioperative Fluid Management for Patients Undergoing Pancreatic Resection
A Prospective Randomized Controlled Clinical Trial of Restrictive Versus Liberal Perioperative Fluid Management for Patients Undergoing Pancreatic Resection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to help us learn what the best amount of fluid is that patients should receive during pancreas surgery. Patients will receive either the liberal fluid amount for this surgery or a restricted fluid amount. Both amounts of fluid have been used safely in patients having similar surgeries. These amounts have not been compared in pancreatic surgery. The fluids regimens that will be given are not experimental. This study will compare patients in the liberal and restricted fluid groups in terms of the nature of any surgical complications (problems)and recovery from surgery, including length of hospital stay.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Liberal perioperative fluid management | Other | — | UNRESOLVED |
| restrictive perioperative fluid management | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- pts undergoing pancreatic resection Restrictive arm
- description
- All patients will receive Normosol or equivalent solution, 0.5 ml/kg/fasted hour IV (approximately from 8am to time of induction) during induction of anesthesia. All patients will then receive maintenance fluids consisting of Normosol or equivalent solution at 6 ml/kg/operative hour. After randomization occurs, those patients randomized to the Restricted Arm will continue to receive Normosol or equivalent solution at 6ml/kg/operative hour.
- interventionNames
- Other: restrictive perioperative fluid management
- type
- ACTIVE_COMPARATOR
- label
- pts undergoing pancreatic resection Liberal arm
- description
- All patients will receive Normosol or equivalent solution, 0.5 ml/kg/fasted hour IV (approximately from midnight to time of induction) during induction of anesthesia. All patients will then receive maintenance fluids consisting of Normosol or equivalent solution at 6 ml/kg/operative hour. Those patients randomized to the Liberal Arm will receive an additional Normosol bolus or equivalent solution equal to (another) 1.5 ml/kg/fasted hour IV (to bring the total to 2 ml/kg/fasted hour) plus an additional bolus of Normosol or equivalent solution 6ml/kg/operative hour to bring the hourly rate to 12ml/kg/operative hour with a maximum of 1000 ml/operative hour.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults \> or = 18 years * Patients scheduled for Pancreaticoduodenectomy, Central Pancreatectomy or Distal Pancreatectomy. Exclusion Criteria: * Pregnancy * History of active coronary disease unless a cardiac stress test showing no reversible ischemia and normal LV function within 30 days of operation * MI within 3 months * History of stroke * History of congestive heart failure and ejection fraction less than 35% * History of severe COPD and resting oxygen saturation (SpO2) \< 90% * Renal dysfunction (Cr \> 1.8) * Abnormal coagulation parameters (INR \> 1.5 not on Coumadin, or platelet * Presence of active infection including HIV * BMI \> 35 * American Society of Anesthesiologists Status \> III, assigned at time of preoperative visit * Corticosteroid use \> 10 mg Prednisone/day * Bilirubin \> 10.0
References
Publications (0)
Data not yet available