Cerebral and Spinal Protection of Xenon Post-conditioning in Patients Undergoing Aortic Dissection Repair
12. května 2016 aktualizováno: WeiPing Cheng, Beijing Anzhen Hospital
With more and more people developing hypertension and atherosclerosis, the morbidity rate of Acute Aortic Dissection（AAD） has been increasing. Emergency surgery is the main treatment for Acute Aortic Dissection. However the secondary injury caused by reperfusion of spinal cord could lead to Catastrophic complications,such as paraplegia, hemiplegia or even death. So spinal protection is always the hot topic in clinical research.
Xenon is an ideal anesthetic gases with the following features,fast onset of action, stable hemodynamics, clean and non-toxic.The animal researches have showed the protective effects of xenon to alleviate the ischemia-reperfusion injury of the nervous system.Those clues suggest that Xenon may have the potential protection of spinal cord in patients undergoing aortic dissection repair.In order to clarify this hypothesis, the investigators designed this randomized, controlled clinic trial to evaluate the protection of Xenon against spinal cord ischemia-reperfusion injury and the potential mechanisms
Přehled studie
Typ studie
Intervenční
Zápis (Očekávaný)
120
Fáze
- Nelze použít
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 až 60 let (Dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- Patients doing selective operation of Bentall and Sun's or partial aortic arch replacement
- Patients doing selective operation of the full chest and abdominal aorta replacement
Exclusion Criteria:
- Emergency patient
- Patients with severe mental and neurological dysfunction
- Patients with severe hearing and visual impairment
- Illiteracy or patients can't cooperate with doing the cognitive function score
- Patients with severe cardiac insufficiency
- critically ill or dying patients
- Patients refuse to sign the informed consent
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: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Žádný zásah: Control group（Ascending aorta）
undergo ascending aorta Dissection Repair and thoracoabdominal aortic Dissection Repair
|
|
|
Experimentální: Xenon Post-conditioning
undergo ascending aorta Dissection Repair and thoracoabdominal aortic Dissection Repair
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
mini mental state examination
Časové okno: 18h before the surgery
|
18h before the surgery
|
|
NIHSS's score
Časové okno: the 1st day after the surgery
|
the 1st day after the surgery
|
|
ASIA impairment scale（ASIA's score ）
Časové okno: 18h before the surgery
|
18h before the surgery
|
|
males
Časové okno: 18h before the surgery
|
18h before the surgery
|
|
age
Časové okno: 18h before the surgery
|
18h before the surgery
|
|
height
Časové okno: 18h before the surgery
|
18h before the surgery
|
|
weight
Časové okno: 18h before the surgery
|
18h before the surgery
|
|
History of Smoking
Časové okno: 18h before the surgery
|
18h before the surgery
|
|
History of Hypertension
Časové okno: 18h before the surgery
|
18h before the surgery
|
|
History of Diabetes Mellitus
Časové okno: 18h before the surgery
|
18h before the surgery
|
|
New York Heart Association Heart function score
Časové okno: 18h before the surgery
|
18h before the surgery
|
|
duration of cardiopulmonary bypass (CPB)
Časové okno: 1h after the surgery
|
1h after the surgery
|
|
duration of Aortic cross-clamping
Časové okno: 1h after the surgery
|
1h after the surgery
|
|
duration of low flow in CPB
Časové okno: 1h after the surgery
|
1h after the surgery
|
|
duration of stopping the circulation
Časové okno: 1h after the surgery
|
1h after the surgery
|
|
the lowest nasopharyngeal temperature
Časové okno: 1h after the surgery
|
1h after the surgery
|
|
the lowest rectal temperature
Časové okno: 1h after the surgery
|
1h after the surgery
|
|
duration of surgery
Časové okno: 1h after the surgery
|
1h after the surgery
|
|
duration of recovering of consciousness from the end of the surgery
Časové okno: 3 days after the surgery
|
3 days after the surgery
|
|
duration of extubation from the end of the surgery
Časové okno: 3 days after the surgery
|
3 days after the surgery
|
|
duration in the ICU
Časové okno: 15 days after the surgery
|
15 days after the surgery
|
|
days in hospital
Časové okno: 15 days after leaving hospital
|
15 days after leaving hospital
|
|
pulmonary infection
Časové okno: 15 days after the surgery
|
15 days after the surgery
|
|
plasma S100β
Časové okno: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
plasma neuron specific enolase,
Časové okno: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
plasma myelin basic protein(MBP)
Časové okno: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
plasma glial fibrillary acidic protein (GFAP)
Časové okno: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
Cerebrospinal fluid(CSF) S100β
Časové okno: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
CSF neuron specific enolase(NSE),
Časové okno: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
CSF MBP
Časové okno: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
CSF GFAP
Časové okno: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
CSF Tumor Necrosis Factor-α(TNF-α)
Časové okno: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
CSF interleukin-10 (IL-10)
Časové okno: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
CSF IL-6
Časové okno: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
CSF IL-2
Časové okno: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
somatosensory evoked potential(SEP)
Časové okno: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
MEP
Časové okno: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
Mini mental state ex amination
Časové okno: the 7th day after the surgery
|
the 7th day after the surgery
|
|
NIHSS's score
Časové okno: the 2nd day after the surgery
|
the 2nd day after the surgery
|
|
NIHSS's score
Časové okno: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
ASIA's score
Časové okno: the 1st day after the surgery
|
the 1st day after the surgery
|
|
ASIA's score
Časové okno: the 2nd day after the surgery
|
the 2nd day after the surgery
|
|
ASIA's score
Časové okno: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
plasma S100β
Časové okno: immediately the end of surgery
|
immediately the end of surgery
|
|
plasma S100β
Časové okno: the 1st day after the surgery
|
the 1st day after the surgery
|
|
plasma S100β
Časové okno: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
plasma S100β
Časové okno: the 7th day after the surgery
|
the 7th day after the surgery
|
|
plasma neuron specific enolase,
Časové okno: immediately the end of surgery
|
immediately the end of surgery
|
|
plasma neuron specific enolase,
Časové okno: the 1st day after the surgery
|
the 1st day after the surgery
|
|
plasma neuron specific enolase,
Časové okno: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
plasma neuron specific enolase,
Časové okno: the 7th day after the surgery
|
the 7th day after the surgery
|
|
plasma MBP
Časové okno: immediately the end of surgery
|
immediately the end of surgery
|
|
plasma MBP
Časové okno: the 1st day after the surgery
|
the 1st day after the surgery
|
|
plasma MBP
Časové okno: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
plasma MBP
Časové okno: the 7th day after the surgery
|
the 7th day after the surgery
|
|
plasma GFAP
Časové okno: immediately the end of surgery
|
immediately the end of surgery
|
|
plasma GFAP
Časové okno: the 1st day after the surgery
|
the 1st day after the surgery
|
|
plasma GFAP
Časové okno: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
plasma GFAP
Časové okno: the 7th day after the surgery
|
the 7th day after the surgery
|
|
CSF S100β
Časové okno: immediately the end of surgery
|
immediately the end of surgery
|
|
CSF S100β
Časové okno: the 1st day after the surgery
|
the 1st day after the surgery
|
|
CSF S100β
Časové okno: the 2nd day after the surgery
|
the 2nd day after the surgery
|
|
CSF S100β
Časové okno: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
CSF neuron specific enolase,
Časové okno: immediately the end of surgery
|
immediately the end of surgery
|
|
CSF neuron specific enolase,
Časové okno: the 1st day after the surgery
|
the 1st day after the surgery
|
|
CSF neuron specific enolase,
Časové okno: the 2nd day after the surgery
|
the 2nd day after the surgery
|
|
CSF neuron specific enolase,
Časové okno: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
CSF MBP
Časové okno: immediately the end of surgery
|
immediately the end of surgery
|
|
CSF MBP
Časové okno: the 1st day after the surgery
|
the 1st day after the surgery
|
|
CSF MBP
Časové okno: the 2nd day after the surgery
|
the 2nd day after the surgery
|
|
CSF MBP
Časové okno: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
CSF GFAP
Časové okno: immediately the end of surgery
|
immediately the end of surgery
|
|
CSF GFAP
Časové okno: the 1st day after the surgery
|
the 1st day after the surgery
|
|
CSF GFAP
Časové okno: the 2nd day after the surgery
|
the 2nd day after the surgery
|
|
CSF GFAP
Časové okno: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
CSF TNF-α
Časové okno: immediately the end of surgery
|
immediately the end of surgery
|
|
CSF TNF-α
Časové okno: the 1st day after the surgery
|
the 1st day after the surgery
|
|
CSF TNF-α
Časové okno: the 2nd day after the surgery
|
the 2nd day after the surgery
|
|
CSF TNF-α
Časové okno: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
CSF IL-10
Časové okno: immediately the end of surgery
|
immediately the end of surgery
|
|
CSF IL-10
Časové okno: the 1st day after surgery
|
the 1st day after surgery
|
|
CSF IL-10
Časové okno: the 2nd day after surgery
|
the 2nd day after surgery
|
|
CSF IL-10
Časové okno: the 3rd day after surgery
|
the 3rd day after surgery
|
|
CSF IL-6
Časové okno: immediately the end of surgery
|
immediately the end of surgery
|
|
CSF IL-6
Časové okno: the 1st day after surgery
|
the 1st day after surgery
|
|
CSF IL-6
Časové okno: the 2nd day after surgery
|
the 2nd day after surgery
|
|
CSF IL-6
Časové okno: the 3rd day after surgery
|
the 3rd day after surgery
|
|
CSF IL-2
Časové okno: immediately the end of surgery
|
immediately the end of surgery
|
|
CSF IL-2
Časové okno: the 1st day after surgery
|
the 1st day after surgery
|
|
CSF IL-2
Časové okno: the 2nd day after surgery
|
the 2nd day after surgery
|
|
CSF IL-2
Časové okno: the 3rd day after surgery
|
the 3rd day after surgery
|
|
SEP
Časové okno: immediately after blocking the aorta
|
immediately after blocking the aorta
|
|
SEP
Časové okno: immediately after opening the aorta
|
immediately after opening the aorta
|
|
SEP
Časové okno: immediately the end of the surgery
|
immediately the end of the surgery
|
|
SEP
Časové okno: the 4th hour after back to ICU
|
the 4th hour after back to ICU
|
|
MEP
Časové okno: immediately after blocking the aorta
|
immediately after blocking the aorta
|
|
MEP
Časové okno: immediately after opening the aorta
|
immediately after opening the aorta
|
|
MEP
Časové okno: immediately the end of the surgery
|
immediately the end of the surgery
|
|
MEP
Časové okno: the 4th hour after back to ICU
|
the 4th hour after back to ICU
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: WeiPing Cheng, master, Chief Physician，Professor
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
1. února 2016
Primární dokončení (Očekávaný)
1. července 2018
Dokončení studie (Očekávaný)
1. září 2018
Termíny zápisu do studia
První předloženo
25. dubna 2016
První předloženo, které splnilo kritéria kontroly kvality
12. května 2016
První zveřejněno (Odhad)
17. května 2016
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
17. května 2016
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
12. května 2016
Naposledy ověřeno
1. května 2016
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- WCheng 2014-8-24
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NEROZHODNÝ
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 .
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