ONSD and Neurotoxicity in Liver Transplant

NCT03799770 | Completed

• 1 other identifier: R.18.12.369 - 2018/12/16
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a diagnostic test accuracy study. The investigators measure optic nerve sheath diameter (ONSD) by ultrasound on the eye during living donor liver transplantation operation at 5 minutes after reperfusion to predict the occurrence of early tacrolimus neurotoxicity after liver transplantation. We measured the ONSD at 4 timings: (T1) Post induction and before surgical incision, (T2) Portal vein clamping, (T3) 5 minutes after reperfusion, and (T4) 30 min after reperfusion.

Conditions

Liver Transplant; Complications

Outcome Measures

Primary Outcomes (1)

• Early tacrolimus neurotoxicity

  definition that will be considered when neurological events (visual disturbance, altered level of consciousness, confusion, psychosis, seizure, encephalopathy, tremors and/or coma or change in the pattern of the preexisting cirrhotic neurological changes ) appeared in the absence of central pontine myelinolysis, central nervous system infection, stroke, or hemorrhage within the first 4 weeks after LT and symptoms improved after dose modification of CNI therapy

  28 days after transplantation

Secondary Outcomes (4)

• Time and presentation of neurotoxicity

  28 days after transplantation

• Intensive Care Unit stay

  until discharge from ICU for 1 year

• Hospital Length of stay

  until discharge from the hospital for 1 year

• Mortality

  three months after transplant

Interventions

Optic nerve sheath diameter by ultrasound at 5 minutes post-reperfucion DIAGNOSTIC_TEST

Patients were placed in the supine position with their eyes closed, and a thick gel layer was applied to the closed upper eyelid. The 7.5-MHz linear probe was placed on the gel without excessive pressure and adjusted to the proper angle for displaying the entry of the optic nerve into the globe. The intensity of the ultrasound was adjusted to display optimal contrast between the retrobulbar echogenic fat tissue and the vertical hypoechoic band. An ultrasound beam was focused on the retrobulbar area using the lowest possible acoustic power that could measure ONSD. The ONSD was measured 3 mm behind the optic disc. Measurements were performed in the transverse and sagittal planes of both eyes, and the final ONSD value was calculated by average 4 measured values. We measured the ONSD at 4 timings: (T1) Post induction and before surgical incision, (T2) Portal vein clamping, (T3) 5 minutes after reperfusion, and (T4) 30 min after reperfusion.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult (\>= 18 years) recipients undergoing living donor liver transplantation

You may qualify if:

• All adult patients of both sex undergoing living donor liver transplantation operation

You may not qualify if:

• History of optic neuritis
• History of Arachnoid cyst of the optic nerve.
• History of eye trauma
• History of optic nerve trauma.
• Familial amylodotic polyneuropathy
• Wilson disease.
• Patient planned to use immunosuppression regimen other than tacrolimus.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Gastroenerology Surgical Center - Liver transplantation program

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

Related Publications (1)

• Elsedeiq M, Abdelkhalek M, Abozeid KM, Habl MS, Elmorshedi MA, Yassen AM, Emara MM. Intraoperative Optic Nerve Sheath Diameter as a Predictor of Early Tacrolimus Neurotoxicity after Living Donor Liver Transplantation. Anaesth Crit Care Pain Med. 2023 Feb;42(1):101178. doi: 10.1016/j.accpm.2022.101178. Epub 2022 Nov 25.

  PMID: 36442803 DERIVED

Study Officials

• Mahmoud M. Elsedeiq, MD

  Lecturer of anaesthesia and intensive care

  PRINCIPAL INVESTIGATOR

• Amr M. Yassin, MD

  professor of anaesthesia and surgical intensive care

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of anaesthesia and surgical intensive care

Study Record Dates

• First Submitted: January 6, 2019
• First Posted: January 10, 2019
• Study Start: January 1, 2019
• Primary Completion: March 23, 2021
• Study Completion: March 23, 2021
• Last Updated: April 12, 2022

Record last verified: 2022-04

Locations

EG (1)