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

Liver Transplantation Clinical Trial

— TOH-HTIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02695823
• Other study ID #: 69HCL15_0483
• Status: Completed
• Phase: N/A
• Start date: December 9, 2015
• Est. completion date: March 2017

Study information

• Verified date: December 2018
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Intracranial Hypertension
• Liver Transplantation

Intervention

Device:
• 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.

Locations

Country	Name	City	State
France	Département d'anesthésie réanimation	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Measurement of intracranial hypertension with transcranial Doppler during surgery.	Diastolic velocity value of less than 20 cm s-1 and a pulsatility index greater than 1.4 will be considered pathological, indicating a high probability of intracranial hypertension.; The transcranial Doppler measurements are performed according to the existing protocols: use of a cardiac probe 2 Mhz, positioned temporal window, the circle of Willis color Doppler tracking then collecting the Doppler signal of the middle cerebral artery in Doppler pulsed with the insonation angle as small as possible to a depth between 40 and 60 mm. Measuring systolic, diastolic and mean velocity )Vs, Vd, Vm) and calculating the pulsatility Index (PI) bilaterally. PI values of> 1.4 and Vd <20 cm s-1 will be considered pathological.	at incision
Secondary	Measurement of intracranial hypertension with transcranial Doppler during surgery.	Diastolic velocity value of less than 20 cm s-1 and a pulsatility index greater than 1.4 will be considered pathological, indicating a high probability of intracranial hypertension.; The transcranial Doppler measurements are performed according to the existing protocols: use of a cardiac probe 2 Mhz, positioned temporal window, the circle of Willis color Doppler tracking then collecting the Doppler signal of the middle cerebral artery in Doppler pulsed with the insonation angle as small as possible to a depth between 40 and 60 mm. Measuring systolic, diastolic and mean velocity )Vs, Vd, Vm) and calculating the pulsatility Index (PI) bilaterally. PI values of> 1.4 and Vd <20 cm s-1 will be considered pathological.	at anhepatic phase + 30 min
Secondary	Measurement of intracranial hypertension with transcranial Doppler during surgery.	Diastolic velocity value of less than 20 cm s-1 and a pulsatility index greater than 1.4 will be considered pathological, indicating a high probability of intracranial hypertension.; The transcranial Doppler measurements are performed according to the existing protocols: use of a cardiac probe 2 Mhz, positioned temporal window, the circle of Willis color Doppler tracking then collecting the Doppler signal of the middle cerebral artery in Doppler pulsed with the insonation angle as small as possible to a depth between 40 and 60 mm. Measuring systolic, diastolic and mean velocity )Vs, Vd, Vm) and calculating the pulsatility Index (PI) bilaterally. PI values of> 1.4 and Vd <20 cm s-1 will be considered pathological.	at declamping + 5 min
Secondary	Measurement of intracranial hypertension with transcranial Doppler during surgery.	Diastolic velocity value of less than 20 cm s-1 and a pulsatility index greater than 1.4 will be considered pathological, indicating a high probability of intracranial hypertension.; The transcranial Doppler measurements are performed according to the existing protocols: use of a cardiac probe 2 Mhz, positioned temporal window, the circle of Willis color Doppler tracking then collecting the Doppler signal of the middle cerebral artery in Doppler pulsed with the insonation angle as small as possible to a depth between 40 and 60 mm. Measuring systolic, diastolic and mean velocity )Vs, Vd, Vm) and calculating the pulsatility Index (PI) bilaterally. PI values of> 1.4 and Vd <20 cm s-1 will be considered pathological.	at declamping + 30 min
Secondary	Measurement of intracranial hypertension with transcranial Doppler	we use the same methods and the same thresholds as those used during surgery (primary outcome measure, and measure1 of secondary outcome measure)	at 1 day after surgery.
Secondary	Measure of the optic nerve sheath diameter after surgery.	we use the same methods and the same thresholds as those used during surgery (primary outcome measure, and measure1 of secondary outcome measure)	at 1 day after surgery.
Secondary	Measurement of intracranial hypertension with transcranial Doppler	we use the same methods and the same thresholds as those used during surgery (primary outcome measure, and measure1 of secondary outcome measure)	at 5 days after surgery.
Secondary	Measure of the optic nerve sheath diameter after surgery.	we use the same methods and the same thresholds as those used during surgery (primary outcome measure, and measure1 of secondary outcome measure)	at 5 days after surgery.
Secondary	The early appearance of neurological complications after surgery.	A monitoring with simultaneous collection of clinical, biological and ultrasound parameters, will be done. Neurological complications after surgery will be defined by the presence of at least one of the following criteria: Glasgow score < 14 in a non-sedated patient, behavioral disorders, agitation (evaluation according to the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) score), epilepsy, imaging or MRI scan. Pathological evolved compared to the preoperative including hemorrhagic or thrombotic cardiovascular event. Various confounding factors will be considered (serum sodium, serum tacrolimus, serum magnesium, ammonia, sedatives).	During the 5 days following surgery