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Mild Hypothermia for Liver Transplant Complications (MHALT Trial)
N/A
Waitlist Available
Led By Michael P Bokoch, MD, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
MHALT Trial Summary
This trial will study whether mild hypothermia during liver transplant surgery can protect against acute kidney injury, which is a common and serious complication of the surgery.
Who is the study for?
This trial is for patients undergoing liver transplantation due to various liver diseases, who will receive a deceased donor's organ. It excludes those with preoperative kidney therapy or intubation, specific types of hypertension and liver failure, recipients of living-donor or simultaneous liver-kidney transplants, and cases where the graft is machine-perfused.Check my eligibility
What is being tested?
The study tests if mild hypothermia (slightly lowering body temperature) during part of the transplant operation can prevent acute kidney injury. Participants are randomly assigned to either mild hypothermia or normal body temperature maintenance (normothermia) groups.See study design
What are the potential side effects?
Potential side effects may include shivering, increased risk of wound infection due to lowered body temperature, changes in blood pressure and heart rate, electrolyte imbalances, and potential impacts on drug metabolism.
MHALT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Acute Kidney Injury (AKI)
Secondary outcome measures
Distribution of the Stages of Acute Kidney Injury (AKI)
Duration of hospital stay
Duration of intensive care unit (ICU) stay
+5 moreOther outcome measures
Blood product transfusions
MHALT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Mild hypothermia & Esophageal cooling/warming deviceExperimental Treatment2 Interventions
The target core temperature is 34-35 °C.
Group II: Normothermia & Esophageal cooling/warming deviceActive Control2 Interventions
The target core temperature is 36.5-37.5 °C.
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
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Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received a liver transplant from a donor who was declared brain dead.You have received a liver transplant from a donor whose heart has stopped beating.You are currently receiving treatment for kidney problems before surgery.You have high blood pressure in the blood vessels in your liver and lungs.Criterion: The liver being used has been preserved using a machine to keep it healthy before transplantation.You have severe liver failure.You have had a liver transplant using a liver from a living donor.You need to have both your liver and kidney transplanted at the same time.
Research Study Groups:
This trial has the following groups:- Group 1: Mild hypothermia & Esophageal cooling/warming device
- Group 2: Normothermia & Esophageal cooling/warming device
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the upper limit for enrollment in this trial?
"Affirmative. Clinicaltrials.gov details that this medical investigation, first published on July 7th 2018, is actively enrolling patients. 230 participants must be enrolled from 3 diverse locations."
Answered by AI
Are there current vacancies for individuals who would like to participate in this experiment?
"Based off of the clinicaltrials.gov listing, this medical trial is in search for participants at this time. It was initially posted on July 7th 2018 and had a recent update on September 13th 2022."
Answered by AI
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