NCT05195125

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

Status unknown Phase 1 Last updated 7 June 2023

What this trial tests

Phase 1 trial testing Direct Peritoneal Resuscitation in End Stage Liver DIsease in 15 participants. Status unknown.

Timeline

1 February 2022

Primary endpoint
1 August 2023

1 December 2023

Quick facts

Lead sponsor	University of Colorado, Denver
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	15
Start date	1 February 2022
Primary completion	1 August 2023
Estimated completion	1 December 2023
Sites	1 location across United States

Drugs / interventions tested

• Direct Peritoneal Resuscitation

Conditions studied

• End Stage Liver DIsease — all drugs for End Stage Liver DIsease →
• Obesity — all drugs for Obesity →
• Acute Kidney Injury — all drugs for Acute Kidney Injury →

Sponsor

University of Colorado, Denver

Who can join

18 and older, any sex, with End Stage Liver DIsease or Obesity. 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.

• Percent of patients that complete DPR infusion without reaching stopping criteria
  Time frame: Up to 24 hours after initiation of direct peritoneal resuscitation

Sponsor's own 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. The combination of elevated BMI and impaired kidney function 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Phase I clinical trial of the feasibility and safety of direct peritoneal resuscitation in liver transplantation.
   Rodriguez IE, Asher ZP, Klingenberg K, Wright FL, et al · · 2024 · PMID 39003094 · DOI 10.1016/j.amjsurg.2024.115815