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

Primary Purpose

End Stage Liver DIsease, Obesity, Acute Kidney Injury

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Direct Peritoneal Resuscitation
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for End Stage Liver DIsease focused on measuring Liver transplant, Obesity, Renal failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • UCHealth - Anschutz Medical Campus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Direct Peritoneal Resuscitation (DPR) Group

Arm Description

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.

Outcomes

Primary Outcome Measures

Percent of patients that complete DPR infusion without reaching stopping criteria

Secondary Outcome Measures

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

Full Information

First Posted
December 14, 2021
Last Updated
June 7, 2023
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT05195125
Brief Title
Use of Direct Peritoneal Resuscitation in High-risk Liver Transplant Recipients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Liver DIsease, Obesity, Acute Kidney Injury
Keywords
Liver transplant, Obesity, Renal failure

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
All study subjects will be enrolled to the treatment arm
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Direct Peritoneal Resuscitation (DPR) Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Direct Peritoneal Resuscitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent of patients that complete DPR infusion without reaching stopping criteria
Time Frame
Up to 24 hours after initiation of direct peritoneal resuscitation
Secondary Outcome Measure Information:
Title
Rate of return to the operating room after index operation
Description
Amount of patients that require a re-operation after their transplant
Time Frame
Up to 7 days after transplant
Title
Abdominal compartment syndrome requiring reoperation
Description
Number of patients that develop increased intraabdominal pressure as a consequence of dialysate infusion
Time Frame
Events that occur during the duration of the DPR infusion, which will last no more than 24 hours after the participant's transplant surgery.
Title
Percent of patients that complete DPR infusion
Time Frame
Up to 24 hours after initiation of DPR
Title
Percent of patients that are transferred to hospital ward
Description
Patients that are admitted to the hospital ward after surgery, not requiring ICU admission
Time Frame
Up to 24 hours after surgery
Title
Rate of early allograft dysfunction
Description
Patients who experience slow function of their transplanted liver after their transplant
Time Frame
Up to 7 days after transplant
Title
Number of blood product units required during first 24 hours postoperatively
Description
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.
Time Frame
Up to 24 hours after transplant
Title
Number of participants that require renal replacement therapy (i.e. hemodialysis) during the first 7 days after liver transplant.
Description
Researches will record whether the participant developed renal failure requiring renal replacement therapy (i.e. hemodialysis)
Time Frame
Up to 7 days after transplant
Title
Hourly urine output for first 24 hours
Time Frame
Up to 24 hours after transplant
Title
Rate of early infection after transplant
Description
Researchers will record any infections that participants develop after transplantation. These may include abscess, peritonitis, bacteremia, and pneumonia.
Time Frame
<7 days postoperatively
Title
Rate of late infection after transplant
Description
Researchers will record any infections that participants develop after transplantation. These may include abscess, peritonitis, bacteremia, and pneumonia.
Time Frame
7-30 days postoperatively
Title
Rate of mechanical bowel obstruction
Description
Constipation caused by compression from inside or outside of the bowel lumen
Time Frame
Up to 30 days after transplant
Title
Ileus/time to oral intake
Description
Time to return of normal bowel function and food tolerance after transplant
Time Frame
Up to 30 days after transplant
Title
Duration of insulin infusion post-operatively
Description
Insulin requirements after transplant surgery
Time Frame
Up to 7 days after transplant
Title
Ventilator free days
Description
Outcome measurement that looks into rate of respiratory failure requiring prolonged mechanical ventilation after transplant surgery
Time Frame
Up to 28 days post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult liver transplant recipients ≥18 y/o Ability to consent Pre-operative Creatinine ≥1.1 (or on dialysis) and BMI ≥30 Exclusion Criteria: Diaphragmatic injury Active spontaneous bacterial peritonitis (SBP) with initiation of antibiotic treatment within 72 hours of surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hunter B Moore, M.D., P.hD.
Organizational Affiliation
University of Colorado School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCHealth - Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26384838
Citation
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.
Results Reference
background
PubMed Identifier
20421025
Citation
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.
Results Reference
background
PubMed Identifier
15761343
Citation
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.
Results Reference
background
PubMed Identifier
24952444
Citation
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.
Results Reference
background
PubMed Identifier
27345902
Citation
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.
Results Reference
background
PubMed Identifier
25797737
Citation
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.
Results Reference
background
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/26384838/
Description
Direct Peritoneal Resuscitation: A review.
URL
https://pubmed.ncbi.nlm.nih.gov/20421025/
Description
Direct peritoneal resuscitation accelerates primary abdominal wall closure after damage control surgery.
URL
https://pubmed.ncbi.nlm.nih.gov/15761343/
Description
Direct peritoneal resuscitation from hemorrhagic shock: effect of time delay in therapy initiation.
URL
https://pubmed.ncbi.nlm.nih.gov/24952444/
Description
Direct peritoneal resuscitation improves inflammation, liver blood flow, and pulmonary edema in a rat model of acute brain death.
URL
https://pubmed.ncbi.nlm.nih.gov/27345902/
Description
Direct Peritoneal Resuscitation Alters Hepatic miRNA Expression after Hemorrhagic Shock.
URL
https://pubmed.ncbi.nlm.nih.gov/25797737/
Description
Addition of direct peritoneal lavage to human cadaver organ donor resuscitation improves organ procurement.

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

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