Effect of Mannitol on Postreperfusion Syndrome During Liv... | NCT05277623

Studies
Effect of Mannitol on Postreperfusion Syndrome During Living Donor Liver Transplant

NCT05277623

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Jan 18, 2023Actual

Enrollment

60Actual

Phase

Early Phase 1

Conditions

Liver Transplant Disorder

Interventions

Mannitol
0.9% normal saline

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 4, 2022Actual

Primary Completion Date

Nov 5, 2022Actual

Completion Date

Dec 10, 2022Actual

First Submitted Date

Mar 4, 2022

First Submission Date that Met QC Criteria

Mar 4, 2022

First Posted Date

Mar 14, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2023

Last Update Posted Date

Jan 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
mannitol group	Active Comparator		Drug: Mannitol
control group	Placebo Comparator		Other: 0.9% normal saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mannitol	Drug	During the anhepatic phase, the patients in the mannitol group (30) will receive 1 g/kg	mannitol group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medicine Ain Shams University		Cairo			Egypt

Intervention Browse Module

MeSH Terms

ID	Term
D008353	Mannitol
D000077330	Saline Solution

Ancestor Terms

ID	Term
D013402	Sugar Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D002241	Carbohydrates

Browse Leaves

Not provided

Browse Branches

Not provided