Transcranial Doppler During Liver Transplantation

NCT05144451 | Unknown

• 1 other identifier: MD.21.09.535
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective study that would investigate the transcranial doppler (TCD) changes during the living donor liver transplantation and the association between the TCD changes and the post-transplant neurological complications.

Conditions

Liver Transplantation; Ultrasonography, Doppler, Transcranial; Complication, Postoperative; Neurologic Deficits

Outcome Measures

Primary Outcomes (1)

• Post-transplant Neurological Complication

  incidence of Neurological Complication as a composite outcome (tremors, seizures, demyelination, posterior reversible encephalopathy syndrome, stroke)

  28 days after transplantation

Secondary Outcomes (1)

• flow patterns throughout the transplant surgery and in the ICU

  intraoperative and 7 days after transplantion

Study Arms (1)

TCD arm

EXPERIMENTAL

All patients will be evaluated with TCD for prediction of the post-transplant neurological complications

Diagnostic Test: Transcranial Doppler

Interventions

Transcranial Doppler DIAGNOSTIC_TEST

Transcranial Doppler-derived parameters; pulsatility index (PI), resistance index (RI), mean flow velocity (Vmean) will be recorded before induction of anesthesia (T1). After induction, TCD parameters, Hemodynamic variables including heart rate (HR), invasive mean arterial blood pressure (MAP), and central venous pressure (CVP) together with Arterial blood gases (ABG analysis with values of PH, PCO2, PO2, blood oxygen saturation SO2 and bicarbonate HCO3), end-tidal carbon dioxide (ETCO2) and body temperature will be recorded too. Just before skin incision (T2), at the end of anhepatic phase 5 minutes before reperfusion (T3), 5 minutes after reperfusion (T4) and at the end of surgery (T5). Postoperatively at ICU, TCD parameters, Hemodynamic variables, and ABG will be obtained 24 hours postoperative (T6) and at discharge from ICU (T7).

Also known as: TCD

TCD arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all patients scheduled for living donor liver transplantation for whatever the indication at Gastrointestinal surgery center (GISC)

You may not qualify if:

• Patients with coexisting neuropsychiatric or cerebrovascular disorders or those who have a history of head trauma or brain surgery

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University, Gastrointestinal Surgery Center, Liver Transplantation Unit

Al Mansurah, Dakahlia Governorate, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Postoperative Complications; Neurologic Manifestations

Interventions

Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Amr M Yassen, MD

  Mansoura University Faculty of Medicine

  STUDY DIRECTOR

Central Study Contacts

Moataz M Emara, MD, EDAIC

CONTACT

+201064048848; mm.emara@mans.edu.eg

Kareem M Abozeid, MSc

CONTACT

1557442411; kareemmohabozeid27@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single-arm trial involving 100 patients undergoing living donor liver transplantation; all will be examined using transcranial doppler to find out its predictive value on post-transplant neurological deficits.

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 3, 2021
• Study Start: November 28, 2021
• Primary Completion: November 28, 2023
• Study Completion: April 28, 2024
• Last Updated: April 14, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: will be updated
• Access Criteria: will be updated

Locations

EG (1)