Transcranial Doppler During Liver Transplantation

Liver Transplantation Clinical Trial

Official title:

Transcranial Doppler and Neurological Complications After Liver Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05144451
• Other study ID #: MD.21.09.535
• Status: Recruiting
• Phase: N/A
• Start date: November 28, 2021
• Est. completion date: April 28, 2024

Study information

• Verified date: April 2022
• Source: Mansoura University
• Contact: Moataz M Emara, MD, EDAIC
• Phone: +201064048848
• Email: mm.emara[@]mans.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Objectives:

Participants & Setting:

Intervention & Measurements:

Sample size:

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 28, 2024
• Est. primary completion date: November 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Complication, Postoperative
• Liver Transplantation
• Neurologic Deficits
• Neurologic Manifestations
• Postoperative Complications
• Ultrasonography, Doppler, Transcranial

Intervention

Diagnostic Test:
• Transcranial Doppler
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).

Locations

Country	Name	City	State
Egypt	Mansoura University, Gastrointestinal Surgery Center, Liver Transplantation Unit	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	flow patterns throughout the transplant surgery and in the ICU	normal, hyperemic, low-flow, or vasospastic flow by TCD	intraoperative and 7 days after transplantion