Effect of Mannitol on Postreperfusion Syndrome During Living Donor Liver Transplant

Sponsor

Ain Shams University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05277623

Collaborator

(none)

Enrollment

Location

Arms

5.8

Anticipated Duration (Months)

10.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Transplant Disorder	Drug: Mannitol Other: 0.9% normal saline	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Mar 7, 2022

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: mannitol group

Drug: Mannitol

During the anhepatic phase, the patients in the mannitol group (30) will receive 1 g/kg

Placebo Comparator: control group

Other: 0.9% normal saline

the same amount of 0.9% normal saline

Outcome Measures

Primary Outcome Measures

mean arterial blood pressure [one hour after reperfusion]
postreperfusion mean blood pressure

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medicine Ain Shams University	Cairo		Egypt

Sponsors and Collaborators

Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mona Ammar, Assistant Professor, Ain Shams University

ClinicalTrials.gov Identifier:

NCT05277623

Other Study ID Numbers:

R 42/ 2022

First Posted:

Mar 14, 2022

Last Update Posted:

Apr 5, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Mannitol

Study Results

No Results Posted as of Apr 5, 2022