Phase I clinical trial utilizing direct peritoneal resuscitation in liver transplant recipient population at increased risk of return to the operating room and early allograft dysfunction.

Primary Objective

Objective I: Determine the safety profile of direct peritoneal resuscitation on liver transplant recipients at risk of return to the operating room and ICU admission. Objective II: Identify if direct peritoneal resuscitation demonstrates a trend towards a reduced rate of return to the operating room compared to historic controls. Objective III: Identify if direct peritoneal resuscitation reduces the rate of early allograft dysfunction and other organ failure following liver transplantation with interval improvement in post-operative fibrinolysis activity.

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Description

This study is being conducted to assess the safety of Direct Peritoneal Resuscitation (DPR) in high-risk liver transplant patients. The investigators want to also identify if this method of recovery after large surgery has the same benefits in liver transplant patients as have been appreciated in other surgical patients. An elevated body mass index (BMI) increases the risk of 1) needing intensive care unit (ICU) admission after surgery, 2) slow function of the new liver [technically termed Early Allograft Dysfunction (EAD)] and 3) need for more than one operation.. The study team also aims to identify if DPR can reduce these risks and not cause other unexpected complications following surgery. DPR involves the infusion of a solution into the abdomen and has been shown to reduce edema and improve blood flow in organs. The solution used in this study is a commercially available peritoneal dialysate, a dextrose containing solution that is infused into the abdominal cavity and is routinely used in patients with end-stage renal disease requiring dialysis.

Details
Age

Adult

Eligibility

Adults undergoing liver transplant with a BMI equal or greater than 30 kg/m2Inclusion criteria: -Adult liver transplant recipients 18 y/o or older -Ability to consent -BMI equal to or greater than 30 kg/m2 Exclusion criteria: -Diaphragmatic injury -Active spontaneous bacterial peritonitis (SBP) with initiation of antibiotic treatment within 72 hours of surgery Stopping Criteria -Drain output < DPR infusion for 2 consecutive hours -RBC transfusion exceeds 10 units within first 24 hours of leaving OR -Concern for abdominal compartment syndrome based on attending/fellow clinician judgment, or confirmatory assessment in sedated patients with anuria, increasing lactate, and bladder pressure > 15 mm hg

Locations

University of Colorado Hospital

Principal Investigator
Photograph of Megan Adams

Megan Adams

Study ID

Protocol Number: 21-4214

More information available at ClinicalTrials.gov: NCT05195125

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