Effect of Mannitol on Postreperfusion Syndrome During Living Donor Liver Transplant

Effect of Mannitol on Postreperfusion Syndrome During Living Donor Liver Transplant: a Randomized Clinical Trial

Postreperfusion syndrome during living liver transplants remains a serious concern for transplant anesthesiologists. This syndrome is responsible for decreases in systemic blood pressure, systemic vascular resistance, and cardiac output and can even lead to cardiac arrest. Delayed graft function and primary graft nonfunction are closely related to postreperfusion syndrome (Therefore, attenuating the syndrome during anesthesia is of great importance.

Study Overview

• Status: Completed
• Conditions: Liver Transplant Disorder
• Intervention / Treatment: Drug: Mannitol; Other: 0.9% normal saline

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Medicine Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients with end-stage liver disease who will undergo living donor transplantation.

Exclusion Criteria:

• Patients with a history of portopulmonary hypertension.
• Hepatopulmonary syndrome.
• Cirrhotic cardiomyopathy.
• Hepatorenal syndrome types 1 and 2.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control group	Other: 0.9% normal saline; the same amount of 0.9% normal saline
Active Comparator: mannitol group	Drug: Mannitol; During the anhepatic phase, the patients in the mannitol group (30) will receive 1 g/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean arterial blood pressure	postreperfusion mean blood pressure	one hour after reperfusion

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2022
• Primary Completion (Actual): November 5, 2022
• Study Completion (Actual): December 10, 2022

Study Registration Dates

• First Submitted: March 4, 2022
• First Submitted That Met QC Criteria: March 4, 2022
• First Posted (Actual): March 14, 2022

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 15, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Natriuretic Agents; Diuretics, Osmotic; Diuretics; Mannitol
• Other Study ID Numbers: R 42/ 2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No