NCT05277623

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Apr 2022

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 14, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

April 4, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2022

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

7 months

First QC Date

March 4, 2022

Last Update Submit

January 15, 2023

Conditions

Liver Transplant Disorder

Outcome Measures

Primary Outcomes (1)

  • mean arterial blood pressure

    postreperfusion mean blood pressure

    one hour after reperfusion

Study Arms (2)

mannitol group

ACTIVE COMPARATOR
Drug: Mannitol

control group

PLACEBO COMPARATOR
Other: 0.9% normal saline

Interventions

MannitolDRUG

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

mannitol group
0.9% normal salineOTHER

the same amount of 0.9% normal saline

control group

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medicine Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Interventions

MannitolSaline Solution

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydratesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 4, 2022

First Posted

March 14, 2022

Study Start

April 4, 2022

Primary Completion

November 5, 2022

Study Completion

December 10, 2022

Last Updated

January 18, 2023

Record last verified: 2023-01

Locations

EG(1)