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

NCT02695823 | Completed

• 1 other identifier: 69HCL15_0483
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Transplantation

Keywords

intracranial hypertension; liver transplantation; transcranial Doppler; optic nerve sheath diameter

Outcome Measures

Primary Outcomes (4)

• Measure of the optic nerve sheath diameter during surgery.

  A value of the optic nerve sheath diameter (averaged over 2 measures) greater than 5.7 mm will be considered pathological, indicating the strong likelihood of intracranial hypertension (PPV near 100% for an intracranial pressure \> 25 cmh2o in the literature) The optic nerve sheath diameter will be measured by ultrasonography, in accordance with existing protocols: Use probe 7.5 Mhz in 2D mode, patient supine dorsi, implementation of ultrasound gel on the closed eyelid, search for the optimal window 3mm, optic nerve sheath diameter measurement behind the retina using an electronic cursor along an axis perpendicular to the optic nerve. 2 measurements per side (sagittal and transverse plane) averaged. Values\> 5.7mm are deemed pathological.

  at incision

• Measure of the optic nerve sheath diameter during surgery.

  A value of the optic nerve sheath diameter (averaged over 2 measures) greater than 5.7 mm will be considered pathological, indicating the strong likelihood of intracranial hypertension (PPV near 100% for an intracranial pressure \> 25 cmh2o in the literature) The optic nerve sheath diameter will be measured by ultrasonography, in accordance with existing protocols: Use probe 7.5 Mhz in 2D mode, patient supine dorsi, implementation of ultrasound gel on the closed eyelid, search for the optimal window 3mm, optic nerve sheath diameter measurement behind the retina using an electronic cursor along an axis perpendicular to the optic nerve. 2 measurements per side (sagittal and transverse plane) averaged. Values\> 5.7mm are deemed pathological.

  at anhepatic phase + 30 min

• Measure of the optic nerve sheath diameter during surgery.

  A value of the optic nerve sheath diameter (averaged over 2 measures) greater than 5.7 mm will be considered pathological, indicating the strong likelihood of intracranial hypertension (PPV near 100% for an intracranial pressure \> 25 cmh2o in the literature) The optic nerve sheath diameter will be measured by ultrasonography, in accordance with existing protocols: Use probe 7.5 Mhz in 2D mode, patient supine dorsi, implementation of ultrasound gel on the closed eyelid, search for the optimal window 3mm, optic nerve sheath diameter measurement behind the retina using an electronic cursor along an axis perpendicular to the optic nerve. 2 measurements per side (sagittal and transverse plane) averaged. Values\> 5.7mm are deemed pathological.

  at declamping + 5 min

• Measure of the optic nerve sheath diameter during surgery.

  A value of the optic nerve sheath diameter (averaged over 2 measures) greater than 5.7 mm will be considered pathological, indicating the strong likelihood of intracranial hypertension (PPV near 100% for an intracranial pressure \> 25 cmh2o in the literature) The optic nerve sheath diameter will be measured by ultrasonography, in accordance with existing protocols: Use probe 7.5 Mhz in 2D mode, patient supine dorsi, implementation of ultrasound gel on the closed eyelid, search for the optimal window 3mm, optic nerve sheath diameter measurement behind the retina using an electronic cursor along an axis perpendicular to the optic nerve. 2 measurements per side (sagittal and transverse plane) averaged. Values\> 5.7mm are deemed pathological.

  at declamping + 30 min

Secondary Outcomes (9)

• Measurement of intracranial hypertension with transcranial Doppler during surgery.

  at incision

• Measurement of intracranial hypertension with transcranial Doppler during surgery.

  at anhepatic phase + 30 min

• Measurement of intracranial hypertension with transcranial Doppler during surgery.

  at declamping + 5 min

• Measurement of intracranial hypertension with transcranial Doppler during surgery.

  at declamping + 30 min

• Measurement of intracranial hypertension with transcranial Doppler

  at 1 day after surgery.

Study Arms (1)

Patients undergoing liver transplantation

EXPERIMENTAL

Device: Ultrasound

Interventions

Ultrasound 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.

Patients undergoing liver transplantation

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Département d'anesthésie réanimation

Lyon, 69004, France

Location

MeSH Terms

Conditions

Intracranial Hypertension

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Mathieu GAZON, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2016
• First Posted: March 1, 2016
• Study Start: December 9, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: December 21, 2018

Record last verified: 2018-12

Locations

FR (1)