NCT01058746

A Prospective Randomized Controlled Clinical Trial of Restrictive Versus Liberal Perioperative Fluid Management for Patients Undergoing Pancreatic Resection

Completed NA Last updated 24 September 2019

What this trial tests

NA trial testing restrictive perioperative fluid management in Pancreatic Cancer in 331 participants. Completed in 1 September 2019.

Timeline

1 January 2010

Primary endpoint
1 September 2019

1 September 2019

Quick facts

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	331
Start date	1 January 2010
Primary completion	1 September 2019
Estimated completion	1 September 2019
Sites	1 location across United States

Drugs / interventions tested

• restrictive perioperative fluid management
• Liberal perioperative fluid management

Conditions studied

• Pancreatic Cancer — all drugs for Pancreatic Cancer →

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

18 and older, any sex, with Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• To determine if restrictive perioperative fluid management results in fewer complications, morbidity and decreased length of stay in patients undergoing pancreatic resection, compared to liberal fluid management.
  Time frame: 3 years

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Intraoperative fluid administration is associated with perioperative outcomes in pancreaticoduodenectomy: a single center retrospective analysis.
   Eng OS, Goswami J, Moore D, Chen C, et al · · 2013 · cited 37× · PMID 23907788 · DOI 10.1002/jso.23393
2. Prospective Randomized Controlled Trial of Liberal Vs Restricted Perioperative Fluid Management in Patients Undergoing Pancreatectomy.
   Grant F, Brennan MF, Allen PJ, DeMatteo RP, et al · · 2016 · cited 30× · PMID 27355261 · DOI 10.1097/sla.0000000000001846
3. Complications after pancreaticoduodenectomy are associated with higher amounts of intra- and postoperative fluid therapy: A single center retrospective cohort study.
   Kulemann B, Fritz M, Glatz T, Marjanovic G, et al · · 2017 · cited 25× · PMID 28289542 · DOI 10.1016/j.amsu.2017.02.042
4. The relationship of perioperative fluid administration to outcomes in colorectal and pancreatic surgery: a review of the literature.
   Eng OS, Melstrom LG, Carpizo DR. · · 2015 · cited 13× · PMID 25643938 · DOI 10.1002/jso.23857