Clinical trial NCT02695823: Incidence of Intracranial Hypertension During Liver Transplantation Estimated by Non-invasive Ultrasound Methods.
Official title: Incidence of Intracranial Hypertension During Liver Transplantation Estimated by Non-invasive Ultrasound Methods.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Transplantation
Keywords: intracranial hypertension
liver transplantation
transcranial Doppler
optic nerve sheath diameter
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-03-01
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Measure of the optic nerve sheath diameter during surgery.
timeFrame: at incision
measure: Measure of the optic nerve sheath diameter during surgery.
timeFrame: at anhepatic phase + 30 min
measure: Measure of the optic nerve sheath diameter during surgery.
timeFrame: at declamping + 5 min
measure: Measure of the optic nerve sheath diameter during surgery.
timeFrame: at declamping + 30 min
Secondary outcomes:
measure: Measurement of intracranial hypertension with transcranial Doppler during surgery.
timeFrame: at incision
measure: Measurement of intracranial hypertension with transcranial Doppler during surgery.
timeFrame: at anhepatic phase + 30 min
measure: Measurement of intracranial hypertension with transcranial Doppler during surgery.
timeFrame: at declamping + 5 min
measure: Measurement of intracranial hypertension with transcranial Doppler during surgery.
timeFrame: at declamping + 30 min
measure: Measurement of intracranial hypertension with transcranial Doppler
timeFrame: at 1 day after surgery.
measure: Measure of the optic nerve sheath diameter after surgery.
timeFrame: at 1 day after surgery.
measure: Measurement of intracranial hypertension with transcranial Doppler
timeFrame: at 5 days after surgery.
measure: Measure of the optic nerve sheath diameter after surgery.
timeFrame: at 5 days after surgery.
measure: The early appearance of neurological complications after surgery.
timeFrame: During the 5 days following surgery
Other outcomes:
Locations:
city: Lyon
country: France
facility: Département d'anesthésie réanimation
Study officials:
affiliation: Hospices Civils de Lyon
name: Mathieu GAZON, MD
role: PRINCIPAL_INVESTIGATOR
References: