Use of Direct Peritoneal Resuscitation in High-risk Liver Transplant Recipients

NCT05195125 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: 21-4214
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

End Stage Liver DIsease; Obesity; Acute Kidney Injury

Keywords

Liver transplant; Obesity; Renal failure

Outcome Measures

Primary Outcomes (1)

• Percent of patients that complete DPR infusion without reaching stopping criteria

  Up to 24 hours after initiation of direct peritoneal resuscitation

Secondary Outcomes (14)

• Rate of return to the operating room after index operation

  Up to 7 days after transplant

• Abdominal compartment syndrome requiring reoperation

  Events that occur during the duration of the DPR infusion, which will last no more than 24 hours after the participant's transplant surgery.

• Percent of patients that complete DPR infusion

  Up to 24 hours after initiation of DPR

• Percent of patients that are transferred to hospital ward

  Up to 24 hours after surgery

• Rate of early allograft dysfunction

  Up to 7 days after transplant

Study Arms (1)

Direct Peritoneal Resuscitation (DPR) Group

EXPERIMENTAL

At the time of abdominal closure and determination that the patient will either go to extended stay or the intensive care unit, three drains will be placed per standard of care. An additional 19 French drain will be placed at the ligament of Treitz at the base of the mesentery. Following abdominal closure DPR will be initiated with commercially available 2.5% glucose-based peritoneal dialysis solution at a rate of 1.5 cc/kg/hr based on previously reported therapy in trauma. Drains will be connected to continuous wall suction. This infusion will continue for the duration the patients stay in extended stay (8 hours) if they are deemed eligible for hospital ward admission, or for 24 hours if requiring ICU care. These patients will then be observed for their hospital course and monitored for outcomes listed above.

Procedure: Direct Peritoneal Resuscitation

Interventions

Direct Peritoneal Resuscitation PROCEDURE

Direct peritoneal resuscitation involves the abdominal infusion and drainage of a peritoneal dialysate in high-risk liver transplant patients, for up to 24 hours after surgery.

Direct Peritoneal Resuscitation (DPR) Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult liver transplant recipients ≥18 y/o
• Ability to consent
• Pre-operative Creatinine ≥1.1 (or on dialysis) and BMI ≥30

You may not qualify if:

• Diaphragmatic injury
• Active spontaneous bacterial peritonitis (SBP) with initiation of antibiotic treatment within 72 hours of surgery

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

UCHealth - Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (6)

• Weaver JL, Smith JW. Direct Peritoneal Resuscitation: A review. Int J Surg. 2016 Sep;33(Pt B):237-241. doi: 10.1016/j.ijsu.2015.09.037. Epub 2015 Sep 16.

  PMID: 26384838 BACKGROUND

• Smith JW, Garrison RN, Matheson PJ, Franklin GA, Harbrecht BG, Richardson JD. Direct peritoneal resuscitation accelerates primary abdominal wall closure after damage control surgery. J Am Coll Surg. 2010 May;210(5):658-64, 664-7. doi: 10.1016/j.jamcollsurg.2010.01.014.

  PMID: 20421025 BACKGROUND

• Zakaria el R, Garrison RN, Kawabe T, Harris PD. Direct peritoneal resuscitation from hemorrhagic shock: effect of time delay in therapy initiation. J Trauma. 2005 Mar;58(3):499-506; discussion 506-8. doi: 10.1097/01.ta.0000152892.24841.54.

  PMID: 15761343 BACKGROUND

• Smith JW, Ghazi CA, Cain BC, Hurt RT, Garrison RN, Matheson PJ. Direct peritoneal resuscitation improves inflammation, liver blood flow, and pulmonary edema in a rat model of acute brain death. J Am Coll Surg. 2014 Jul;219(1):79-87. doi: 10.1016/j.jamcollsurg.2014.03.045. Epub 2014 Apr 5.

  PMID: 24952444 BACKGROUND

• Weaver JL, Matheson PJ, Hurt RT, Downard CD, McClain CJ, Garrison RN, Smith JW. Direct Peritoneal Resuscitation Alters Hepatic miRNA Expression after Hemorrhagic Shock. J Am Coll Surg. 2016 Jul;223(1):68-75. doi: 10.1016/j.jamcollsurg.2016.03.024. Epub 2016 Mar 26.

  PMID: 27345902 BACKGROUND

• Smith JW, Matheson PJ, Morgan G, Matheson A, Downard C, Franklin GA, Garrison RN. Addition of direct peritoneal lavage to human cadaver organ donor resuscitation improves organ procurement. J Am Coll Surg. 2015 Apr;220(4):539-47. doi: 10.1016/j.jamcollsurg.2014.12.056. Epub 2015 Feb 9.

  PMID: 25797737 BACKGROUND

Related Links

• Direct Peritoneal Resuscitation: A review.
• Direct peritoneal resuscitation accelerates primary abdominal wall closure after damage control surgery.
• Direct peritoneal resuscitation from hemorrhagic shock: effect of time delay in therapy initiation.
• Direct peritoneal resuscitation improves inflammation, liver blood flow, and pulmonary edema in a rat model of acute brain death.
• Direct Peritoneal Resuscitation Alters Hepatic miRNA Expression after Hemorrhagic Shock.
• Addition of direct peritoneal lavage to human cadaver organ donor resuscitation improves organ procurement.

MeSH Terms

Conditions

End Stage Liver Disease; Obesity; Acute Kidney Injury; Renal Insufficiency

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Hunter B Moore, M.D., P.hD.

  University of Colorado School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All study subjects will be enrolled to the treatment arm

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 18, 2022
• Study Start: February 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 8, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)