NCT05031026

Brief Summary

the aim of the study is to approve the hypothesis that dexmedetomidine can protect against glycocalyx degradation induced by hepatic ischemia-reperfusion injury and hence can reduce the subsequent complications as early allograft dysfunction, other organ dysfunction and hemodynamic instability

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2022

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

August 17, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 1, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

March 15, 2022

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2026

Completed
Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

3.8 years

First QC Date

August 17, 2021

Last Update Submit

September 29, 2025

Conditions

Liver Transplant; Complications

Outcome Measures

Primary Outcomes (1)

  • syndecan-1 level

    Change in syndecan-1 level 5 minutes after hepatic artery declamping

    48 hours

Secondary Outcomes (7)

  • Incidence of Primary nonunction (PNF) which is defined as graft loss, retransplantation, or participant death due to graft non-function in first 30 days without detectable technical or immunological problems.

    30 days

  • Incidence of acute kidney injury ( AKI ) during postoperative days 1-7.

    7 days

  • Incidence of acute respiratory distress syndrome ( ARDS ) during postoperative days 1-7. Defined according to Berlin modification of the American European Consensus Committee (AECC) definitions published in 2012

    7 days

  • duration of post-operative mechanical ventilation

    30 days

  • ICU and hospital stay after surgery.

    60 days

  • +2 more secondary outcomes

Study Arms (3)

donor group

ACTIVE COMPARATOR

where donors only will receive dexmedetomidine

Drug: Dexmedetomidine

recpient group

ACTIVE COMPARATOR

where recepients only will receive dexmedetomidine

Drug: Dexmedetomidine

control group

PLACEBO COMPARATOR

both donors and recipients will receive a placebo

Drug: Normal Saline

Interventions

DexmedetomidineDRUG

dexmedetomidine infusion rule in prevention of IRI

Also known as: Precedex
donor grouprecpient group
Normal SalineDRUG

normal saline infusion as a placebo

Also known as: NS 0.9%
control group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients aged 18-60 years.
  • Model for end-stage liver disease (MELD) score 12-20.
  • No severe hemodynamic instability.
  • The liver donors aged 18-50 years and the sum of macro- and microvesicular hepatic steatosis has to be less than 30%.

You may not qualify if:

  • History of psychiatric/neurological illness.
  • Cardiovascular disease.
  • Hypertensive patients.
  • Morbid obese patients (body mass index (BMI) \> 35).
  • Chronic obstructive pulmonary disease; pulmonary dysfunction (PaO2 less than 60 mmHg).
  • Known allergic reaction to any of the study medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 088, Egypt

Location

Related Publications (4)

  • Zhu YX, Zhou JH, Li GW, Zhou WY, Ou SS, Xiao XY. Dexmedetomidine protects liver cell line L-02 from oxygen-glucose deprivation-induced injury by down-regulation of microRNA-711. Eur Rev Med Pharmacol Sci. 2018 Oct;22(19):6507-6516. doi: 10.26355/eurrev_201810_16065.

    PMID: 30338821BACKGROUND

  • Nieuwdorp M, van Haeften TW, Gouverneur MC, Mooij HL, van Lieshout MH, Levi M, Meijers JC, Holleman F, Hoekstra JB, Vink H, Kastelein JJ, Stroes ES. Loss of endothelial glycocalyx during acute hyperglycemia coincides with endothelial dysfunction and coagulation activation in vivo. Diabetes. 2006 Feb;55(2):480-6. doi: 10.2337/diabetes.55.02.06.db05-1103.

    PMID: 16443784BACKGROUND

  • Mathis S, Putzer G, Schneeberger S, Martini J. The Endothelial Glycocalyx and Organ Preservation-From Physiology to Possible Clinical Implications for Solid Organ Transplantation. Int J Mol Sci. 2021 Apr 13;22(8):4019. doi: 10.3390/ijms22084019.

    PMID: 33924713RESULT

  • Fayed NA, Sayed EI, Saleh SM, Ehsan NA, Elfert AY. Effect of dexmedetomidine on hepatic ischemia-reperfusion injury in the setting of adult living donor liver transplantation. Clin Transplant. 2016 Apr;30(4):470-82. doi: 10.1111/ctr.12713. Epub 2016 Mar 3.

    PMID: 26856320RESULT

MeSH Terms

Interventions

DexmedetomidineSaline Solution

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

August 17, 2021

First Posted

September 1, 2021

Study Start

March 15, 2022

Primary Completion

December 15, 2025

Study Completion

February 15, 2026

Last Updated

October 2, 2025

Record last verified: 2025-09

Locations

EG(1)