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

Phase 1

Active, not recruiting

• Conditions: Obesity; Acute Kidney Injury; End Stage Liver DIsease
• Interventions: Procedure: Direct Peritoneal Resuscitation

• Registration Number: NCT05195125
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

The central hypothesis of this study is that direct peritoneal resuscitation is a safe therapy following liver transplantation and is associated with a reduced rate of return to the operating room.

AIM 1: Determine the safety profile of direct peritoneal resuscitation on liver transplant recipients at risk of return to the operating room and ICU admission. Hypothesis: Liver transplant recipients that receive DPR will have comparable complication rates to historic controls of liver transplant recipients with similar demographics.

AIM 2: Identify if direct peritoneal resuscitation demonstrates a trend towards a reduced rate of return to the operating room compared to historic controls. Hypothesis: DPR will demonstrate a trend of a reduce rate of return to the operating room of liver transplant patients after index operation compared to historic controls.

AIM 3: 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. Hypothesis: DPR will reduce the rate of EAD of liver transplant patients compared to historic controls and is associated with increased fibrinolysis in the post-operative period.

Study Timeline

• Study First Submitted: 2021-12-14
• Study First Submitted QC: 2022-01-12
• Study First Posted: 2022-01-18
• Study Start: 2022-02-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-07
• Last Update Posted: 2023-06-08
• Primary Completion: 2023-08
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Direct Peritoneal Resuscitation (DPR) Group	Direct Peritoneal Resuscitation	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.	Number of patients that develop increased intraabdominal pressure as a consequence of dialysate infusion
Rate of return to the operating room after index operation	Up to 7 days after transplant	Amount of patients that require a re-operation after their transplant
Hourly urine output for first 24 hours	Up to 24 hours after transplant
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	Patients that are admitted to the hospital ward after surgery, not requiring ICU admission
Rate of early allograft dysfunction	Up to 7 days after transplant	Patients who experience slow function of their transplanted liver after their transplant
Number of blood product units required during first 24 hours postoperatively	Up to 24 hours after transplant	The study team will record the number of units of blood product (i.e. "bags" of red blood cells, platelets, etc.) required by the participant in the first day after liver transplantation.
Number of participants that require renal replacement therapy (i.e. hemodialysis) during the first 7 days after liver transplant.	Up to 7 days after transplant	Researches will record whether the participant developed renal failure requiring renal replacement therapy (i.e. hemodialysis)
Rate of late infection after transplant	7-30 days postoperatively	Researchers will record any infections that participants develop after transplantation. These may include abscess, peritonitis, bacteremia, and pneumonia.
Rate of early infection after transplant	<7 days postoperatively	Researchers will record any infections that participants develop after transplantation. These may include abscess, peritonitis, bacteremia, and pneumonia.
Duration of insulin infusion post-operatively	Up to 7 days after transplant	Insulin requirements after transplant surgery
Ventilator free days	Up to 28 days post-op	Outcome measurement that looks into rate of respiratory failure requiring prolonged mechanical ventilation after transplant surgery
Rate of mechanical bowel obstruction	Up to 30 days after transplant	Constipation caused by compression from inside or outside of the bowel lumen
Ileus/time to oral intake	Up to 30 days after transplant	Time to return of normal bowel function and food tolerance after transplant

Trial Locations

Locations (1)

UCHealth - Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States