Transcranial Doppler During Liver Transplantation

Sponsor

Mansoura University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05144451

Collaborator

(none)

100

Enrollment

Location

Arm

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Transplantation Ultrasonography, Doppler, Transcranial Complication, Postoperative Neurologic Deficits	Diagnostic Test: Transcranial Doppler	N/A

Detailed Description

Objectives:

Participants & Setting:

Intervention & Measurements:

Sample size:

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Transcranial Doppler and Neurological Complications After Liver Transplantation

Actual Study Start Date :

Nov 28, 2021

Anticipated Primary Completion Date :

Nov 28, 2023

Anticipated Study Completion Date :

Apr 28, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TCD arm All patients will be evaluated with TCD for prediction of the post-transplant neurological complications	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). Other Names: TCD

Arm

Intervention/Treatment

Experimental: TCD arm

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

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).

Other Names:

TCD

Outcome Measures

Primary Outcome Measures

Post-transplant Neurological Complication [28 days after transplantation]
incidence of Neurological Complication as a composite outcome (tremors, seizures, demyelination, posterior reversible encephalopathy syndrome, stroke)

Secondary Outcome Measures

flow patterns throughout the transplant surgery and in the ICU [intraoperative and 7 days after transplantion]
normal, hyperemic, low-flow, or vasospastic flow by TCD

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura University, Gastrointestinal Surgery Center, Liver Transplantation Unit	Mansoura	Dakahlia	Egypt	35516

Sponsors and Collaborators

Mansoura University

Investigators

Study Director: Amr M Yassen, MD, Mansoura University Faculty of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mansoura University

ClinicalTrials.gov Identifier:

NCT05144451

Other Study ID Numbers:

MD.21.09.535

First Posted:

Dec 3, 2021

Last Update Posted:

Apr 14, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neurologic Manifestations

Postoperative Complications

Study Results

No Results Posted as of Apr 14, 2022