Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

Incidence of Intracranial Hypertension During Liver Transplantation Estimated by Non-invasive Ultrasound Methods. (TOH-HTIC)

20. prosince 2018 aktualizováno: Hospices Civils de Lyon

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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

29

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Francie
      • Lyon, Francie, 69004
        • Département d'anesthésie réanimation

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Diagnostický
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Patients undergoing liver transplantation
Přístroj: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Measure of the optic nerve sheath diameter during surgery.
Časové okno: at incision
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.
Časové okno: at anhepatic phase + 30 min
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.
Časové okno: at declamping + 5 min
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.
Časové okno: at declamping + 30 min
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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Measurement of intracranial hypertension with transcranial Doppler during surgery.
Časové okno: at incision

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
Measurement of intracranial hypertension with transcranial Doppler during surgery.
Časové okno: at anhepatic phase + 30 min

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
Measurement of intracranial hypertension with transcranial Doppler during surgery.
Časové okno: at declamping + 5 min

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
Measurement of intracranial hypertension with transcranial Doppler during surgery.
Časové okno: at declamping + 30 min

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
Measurement of intracranial hypertension with transcranial Doppler
Časové okno: at 1 day 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.
Measure of the optic nerve sheath diameter after surgery.
Časové okno: at 1 day 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.
Measurement of intracranial hypertension with transcranial Doppler
Časové okno: at 5 days 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.
Measure of the optic nerve sheath diameter after surgery.
Časové okno: at 5 days 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.
The early appearance of neurological complications after surgery.
Časové okno: During the 5 days following 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Hospices Civils de Lyon

Vyšetřovatelé

  • Vrchní vyšetřovatel: Mathieu GAZON, MD, Hospices Civils de Lyon

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

9. prosince 2015

Primární dokončení (Aktuální)

1. března 2017

Dokončení studie (Aktuální)

1. března 2017

Termíny zápisu do studia

První předloženo

11. února 2016

První předloženo, které splnilo kritéria kontroly kvality

29. února 2016

První zveřejněno (Odhad)

1. března 2016

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

21. prosince 2018

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

20. prosince 2018

Naposledy ověřeno

1. prosince 2018

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 69HCL15_0483

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Ultrasound

Prohledejte podobné pokusy

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Zimbabwe

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

3
Předplatit