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Optic Nerve Sheath Diameter As A Predictor Of Early Tacrolimus Neurotoxicity In Living Donor Liver Transplantation

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ClinicalTrials.gov Identifier: NCT03799770
Recruitment Status : Recruiting
First Posted : January 10, 2019
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Amr M. Yassen, Mansoura University

Brief Summary:
this is observational study . the investigator will measure optic nerve sheath diameter by ultrasound on the eye during living donor liver transplantation operation at different stages to predict the occurance of early tacrolimus neurotoxicity post liver transplantation.

Condition or disease Intervention/treatment
Liver Transplant; Complications Diagnostic Test: measurment of optic nerve sheath diameter by ultrasound

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Perioperative Optic Nerve Sheath Diameter As A Predictor Of Early Tacrolimus Neurotoxicity In Living Donor Liver Transplantation
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus


Intervention Details:
  • Diagnostic Test: measurment of optic nerve sheath diameter by ultrasound
    Sonographic measurement of ONSD was performed with the same manner of previous studies. 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 averaging 4 measured values.


Primary Outcome Measures :
  1. measurment of optic nerve sheath diameter during surgery [ Time Frame: intraoperative ]
    measurment of optic nerve sheath diameter by ultrasound . the optimal cutoff of ONSD for the detection of an acutely increased ICP > 20 mm Hg was greater than 4.8 mm.

  2. measurment of optic nerve sheath diameter during surgery [ Time Frame: 5 minutes before reperfusion ]
    measurment of optic nerve sheath diameter by ultrasound . the optimal cutoff of ONSD for the detection of an acutely increased ICP > 20 mm Hg was greater than 4.8 mm.

  3. measurment of optic nerve sheath diameter during surgery [ Time Frame: 5 minutes after reperfusion ]
    measurment of optic nerve sheath diameter by ultrasound . the optimal cutoff of ONSD for the detection of an acutely increased ICP > 20 mm Hg was greater than 4.8 mm.

  4. measurment of optic nerve sheath diameter during surgery [ Time Frame: 30 min after reperfusion ]
    measurment of optic nerve sheath diameter by ultrasound . the optimal cutoff of ONSD for the detection of an acutely increased ICP > 20 mm Hg was greater than 4.8 mm.

  5. Occurrence of tacrolimus immunosuppression neurotoxicity [ Time Frame: one month post liver transplantation ]
    definition that will be considered when moderate or severe 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


Secondary Outcome Measures :
  1. measurment of optic nerve sheath diameter after surgery [ Time Frame: day 1 ]
    measurment of optic nerve sheath diameter by ultrasound . the optimal cutoff of ONSD for the detection of an acutely increased ICP > 20 mm Hg was greater than 4.8 mm.

  2. measurment of optic nerve sheath diameter after neurotoxicity [ Time Frame: One month ]
    measurment of optic nerve sheath diameter by ultrasound . the optimal cutoff of ONSD for the detection of an acutely increased ICP > 20 mm Hg was greater than 4.8 mm.

  3. tacrolimus level [ Time Frame: one month post liver transplant ]
    measured by immunoassay level more than 13 considered high



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
all recepients undergiong living donor liver transplantation
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with a history of optic neuritis
  • Patient with history of Arachnoid cyst of the optic nerve.
  • Patient with history of eye trauma
  • Patient with history of optic nerve trauma.
  • Patient with familial amylodotic polyneuropathy
  • Patient with Wilson disease.
  • Patient planned to use immunosuppression regimen other than tacrolimus.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03799770


Contacts
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Contact: Mahmoud M. Elsedeiq, Msc 01095378336 ext 002 mahmoudelsedeik1987@yahoo.com
Contact: Amr M. Yassin, MD 01001497044 ext 002 amryassen@hotmail.com

Locations
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Egypt
Gastroenerology Surgical Center - Liver transplantation program Recruiting
Mansourah, Dakahlia, Egypt, 35516
Contact: Mahmoud M. Elsedeiq, MSc    01095378336 ext 002    mahmoudelsedeik1987@yahoo.com   
Contact: Amr M. Yassin, MD    01001497044 ext 002    amryassen@hotmail.com   
Sponsors and Collaborators
Mansoura University
Investigators
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Principal Investigator: Mahmoud M. Elsedeiq, Msc assistant lecturer of anaesthesia and intensive care
Study Director: Amr M. Yassin, MD professor of anaesthesia and surgical intensive care

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Responsible Party: Amr M. Yassen, professor of anaesthesia and surgical intensive care, Mansoura University
ClinicalTrials.gov Identifier: NCT03799770     History of Changes
Other Study ID Numbers: R.18.12.369 - 2018/12/16
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Neurotoxicity Syndromes
Nervous System Diseases
Poisoning
Chemically-Induced Disorders
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action