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Incidence of Intracranial Hypertension During Liver Transplantation Estimated by Non-invasive Ultrasound Methods.

NCT ID: NCT02695823

Last Updated: 2018-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-09

Study Completion Date

2017-03-31

Brief Summary

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Acute or chronic liver failure (fulminant hepatitis or advanced cirrhosis) disrupts brain physiology. Beyond classical hepatic encephalopathy, intracranial hypertension may occur.During liver transplantation (LT) surgery, many factors can lead to cerebral assault. In addition, intracranial hypertension measured with invasive methods has been described in certain phases of LT, especially at the time of reperfusion.

The invasive monitoring of the intracranial pressure is not used in these patients, due to a high risk of infection and bleeding. The non-invasive monitoring of intracranial pressure has been widely developed in recent years : transcranial doppler and recently ultrasound of the optic nerve sheath (ONSD) allow an effective detection of intracranial hypertension.

Detailed Description

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Conditions

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Liver Transplantation

Keywords

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intracranial hypertension liver transplantation transcranial Doppler optic nerve sheath diameter

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients undergoing liver transplantation

Group Type EXPERIMENTAL

Ultrasound

Intervention Type DEVICE

Ultrasound measurements of the optic nerve sheath diameter and intracranial Doppler, at 4 time points during surgery (incision, anhepatic phase + 30 min, declamping + 5 min, declamping + 30 min), and at day 1 and day 5 after surgery, to detect presence of intracranial hypertension.

Search of any neurological complication during the 5 postoperative days.

Interventions

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Ultrasound

Ultrasound measurements of the optic nerve sheath diameter and intracranial Doppler, at 4 time points during surgery (incision, anhepatic phase + 30 min, declamping + 5 min, declamping + 30 min), and at day 1 and day 5 after surgery, to detect presence of intracranial hypertension.

Search of any neurological complication during the 5 postoperative days.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients ≥ 18 years
* Patients who underwent orthotopic liver transplantation
* Patients who have received clear information and not opposed to participate in the study
* Patients affiliated to a social security scheme or similar
* Patients not undergoing a measure of legal protection

Exclusion Criteria

* Opposition to participation in the study
* Patients \< 18 years
* Pregnant women or breastfeeding
* Deprived of individual liberty
* Non-affiliated to a social security scheme
* Known ophthalmic pathology: untreated cataracts, glaucoma
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mathieu GAZON, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Département d'anesthésie réanimation

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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69HCL15_0483

Identifier Type: -

Identifier Source: org_study_id