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End Stage Liver DIseasePhase 1NCT05195125

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

A Phase 1 study testing Direct Peritoneal Resuscitation in people with End Stage Liver DIsease and Obesity, run by University of Colorado, Denver at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Direct Peritoneal Resuscitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
1 Feb 2022to Dec 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UCHealth - Anschutz Medical Campus

    Aurora, Colorado, 80045

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Direct Peritoneal Resuscitation
Keywords
Liver transplant, Obesity, Renal failure
Medical subject headings
End Stage Liver Disease, Obesity, Acute Kidney Injury, Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Direct Peritoneal ResuscitationProcedure or surgery

    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.

Study groups in NCT05195125
Study groupRoleWhat they receive
Direct Peritoneal Resuscitation (DPR) GroupExperimentalAt 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.
Receives: Procedure: Direct Peritoneal Resuscitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent of patients that complete DPR infusion without reaching stopping criteria

    Measured: Up to 24 hours after initiation of direct peritoneal resuscitation

Secondary outcomes (14)

  1. Rate of return to the operating room after index operation

    Amount of patients that require a re-operation after their transplant

    Measured: Up to 7 days after transplant

  2. Abdominal compartment syndrome requiring reoperation

    Number of patients that develop increased intraabdominal pressure as a consequence of dialysate infusion

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

  3. Percent of patients that complete DPR infusion

    Measured: Up to 24 hours after initiation of DPR

  4. Percent of patients that are transferred to hospital ward

    Patients that are admitted to the hospital ward after surgery, not requiring ICU admission

    Measured: Up to 24 hours after surgery

  5. Rate of early allograft dysfunction

    Patients who experience slow function of their transplanted liver after their transplant

    Measured: Up to 7 days after transplant

  6. 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.

    Measured: Up to 24 hours after transplant

  7. 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)

    Measured: Up to 7 days after transplant

  8. Hourly urine output for first 24 hours

    Measured: Up to 24 hours after transplant

  9. Rate of early infection after transplant

    Researchers will record any infections that participants develop after transplantation. These may include abscess, peritonitis, bacteremia, and pneumonia.

    Measured: <7 days postoperatively

  10. Rate of late infection after transplant

    Researchers will record any infections that participants develop after transplantation. These may include abscess, peritonitis, bacteremia, and pneumonia.

    Measured: 7-30 days postoperatively

  11. Rate of mechanical bowel obstruction

    Constipation caused by compression from inside or outside of the bowel lumen

    Measured: Up to 30 days after transplant

  12. Ileus/time to oral intake

    Time to return of normal bowel function and food tolerance after transplant

    Measured: Up to 30 days after transplant

  13. Duration of insulin infusion post-operatively

    Insulin requirements after transplant surgery

    Measured: Up to 7 days after transplant

  14. Ventilator free days

    Outcome measurement that looks into rate of respiratory failure requiring prolonged mechanical ventilation after transplant surgery

    Measured: Up to 28 days post-op

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2022
  2. Study start1 Feb 2022
  3. Primary completionAug 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
All study subjects will be enrolled to the treatment arm
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05195125
Sponsor's protocol ID
21-4214
Status last verified
Jun 2023
First submitted
14 Dec 2021
Last updated
8 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26384838

  • 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.

    PubMed 20421025

  • 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.

    PubMed 15761343

  • 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.

    PubMed 24952444

  • 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.

    PubMed 27345902

  • 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.

    PubMed 25797737

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Direct Peritoneal Resuscitation in people with End Stage Liver DIsease and Obesity, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of patients that complete DPR infusion without reaching stopping criteria (time frame: Up to 24 hours after initiation of direct peritoneal resuscitation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05195125, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.

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