Denne side blev automatisk oversat, og nøjagtigheden af oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Cerebral and Spinal Protection of Xenon Post-conditioning in Patients Undergoing Aortic Dissection Repair

12. maj 2016 opdateret af: 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

Studieoversigt

Status

Ukendt

Betingelser

Aortadissektion

Intervention / Behandling

Medicin: xenon

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

120

Fase

Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 60 år (Voksen)

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Forebyggelse
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Firedobbelt

Antal våben

Våben og indgreb

Deltagergruppe / Arm	Intervention / Behandling
Ingen indgriben: Control group（Ascending aorta） undergo ascending aorta Dissection Repair and thoracoabdominal aortic Dissection Repair
Eksperimentel: Xenon Post-conditioning undergo ascending aorta Dissection Repair and thoracoabdominal aortic Dissection Repair	Medicin: xenon

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Tidsramme
mini mental state examination Tidsramme: 18h before the surgery	18h before the surgery
NIHSS's score Tidsramme: the 1st day after the surgery	the 1st day after the surgery
ASIA impairment scale（ASIA's score ） Tidsramme: 18h before the surgery	18h before the surgery
males Tidsramme: 18h before the surgery	18h before the surgery
age Tidsramme: 18h before the surgery	18h before the surgery
height Tidsramme: 18h before the surgery	18h before the surgery
weight Tidsramme: 18h before the surgery	18h before the surgery
History of Smoking Tidsramme: 18h before the surgery	18h before the surgery
History of Hypertension Tidsramme: 18h before the surgery	18h before the surgery
History of Diabetes Mellitus Tidsramme: 18h before the surgery	18h before the surgery
New York Heart Association Heart function score Tidsramme: 18h before the surgery	18h before the surgery
duration of cardiopulmonary bypass (CPB) Tidsramme: 1h after the surgery	1h after the surgery
duration of Aortic cross-clamping Tidsramme: 1h after the surgery	1h after the surgery
duration of low flow in CPB Tidsramme: 1h after the surgery	1h after the surgery
duration of stopping the circulation Tidsramme: 1h after the surgery	1h after the surgery
the lowest nasopharyngeal temperature Tidsramme: 1h after the surgery	1h after the surgery
the lowest rectal temperature Tidsramme: 1h after the surgery	1h after the surgery
duration of surgery Tidsramme: 1h after the surgery	1h after the surgery
duration of recovering of consciousness from the end of the surgery Tidsramme: 3 days after the surgery	3 days after the surgery
duration of extubation from the end of the surgery Tidsramme: 3 days after the surgery	3 days after the surgery
duration in the ICU Tidsramme: 15 days after the surgery	15 days after the surgery
days in hospital Tidsramme: 15 days after leaving hospital	15 days after leaving hospital
pulmonary infection Tidsramme: 15 days after the surgery	15 days after the surgery
plasma S100β Tidsramme: immediately after anesthesia induction	immediately after anesthesia induction
plasma neuron specific enolase, Tidsramme: immediately after anesthesia induction	immediately after anesthesia induction
plasma myelin basic protein(MBP) Tidsramme: immediately after anesthesia induction	immediately after anesthesia induction
plasma glial fibrillary acidic protein (GFAP) Tidsramme: immediately after anesthesia induction	immediately after anesthesia induction
Cerebrospinal fluid(CSF) S100β Tidsramme: immediately after anesthesia induction	immediately after anesthesia induction
CSF neuron specific enolase(NSE), Tidsramme: immediately after anesthesia induction	immediately after anesthesia induction
CSF MBP Tidsramme: immediately after anesthesia induction	immediately after anesthesia induction
CSF GFAP Tidsramme: immediately after anesthesia induction	immediately after anesthesia induction
CSF Tumor Necrosis Factor-α(TNF-α) Tidsramme: immediately after anesthesia induction	immediately after anesthesia induction
CSF interleukin-10 (IL-10) Tidsramme: immediately after anesthesia induction	immediately after anesthesia induction
CSF IL-6 Tidsramme: immediately after anesthesia induction	immediately after anesthesia induction
CSF IL-2 Tidsramme: immediately after anesthesia induction	immediately after anesthesia induction
somatosensory evoked potential(SEP) Tidsramme: immediately after anesthesia induction	immediately after anesthesia induction
MEP Tidsramme: immediately after anesthesia induction	immediately after anesthesia induction
Mini mental state ex amination Tidsramme: the 7th day after the surgery	the 7th day after the surgery
NIHSS's score Tidsramme: the 2nd day after the surgery	the 2nd day after the surgery
NIHSS's score Tidsramme: the 3rd day after the surgery	the 3rd day after the surgery
ASIA's score Tidsramme: the 1st day after the surgery	the 1st day after the surgery
ASIA's score Tidsramme: the 2nd day after the surgery	the 2nd day after the surgery
ASIA's score Tidsramme: the 3rd day after the surgery	the 3rd day after the surgery
plasma S100β Tidsramme: immediately the end of surgery	immediately the end of surgery
plasma S100β Tidsramme: the 1st day after the surgery	the 1st day after the surgery
plasma S100β Tidsramme: the 3rd day after the surgery	the 3rd day after the surgery
plasma S100β Tidsramme: the 7th day after the surgery	the 7th day after the surgery
plasma neuron specific enolase, Tidsramme: immediately the end of surgery	immediately the end of surgery
plasma neuron specific enolase, Tidsramme: the 1st day after the surgery	the 1st day after the surgery
plasma neuron specific enolase, Tidsramme: the 3rd day after the surgery	the 3rd day after the surgery
plasma neuron specific enolase, Tidsramme: the 7th day after the surgery	the 7th day after the surgery
plasma MBP Tidsramme: immediately the end of surgery	immediately the end of surgery
plasma MBP Tidsramme: the 1st day after the surgery	the 1st day after the surgery
plasma MBP Tidsramme: the 3rd day after the surgery	the 3rd day after the surgery
plasma MBP Tidsramme: the 7th day after the surgery	the 7th day after the surgery
plasma GFAP Tidsramme: immediately the end of surgery	immediately the end of surgery
plasma GFAP Tidsramme: the 1st day after the surgery	the 1st day after the surgery
plasma GFAP Tidsramme: the 3rd day after the surgery	the 3rd day after the surgery
plasma GFAP Tidsramme: the 7th day after the surgery	the 7th day after the surgery
CSF S100β Tidsramme: immediately the end of surgery	immediately the end of surgery
CSF S100β Tidsramme: the 1st day after the surgery	the 1st day after the surgery
CSF S100β Tidsramme: the 2nd day after the surgery	the 2nd day after the surgery
CSF S100β Tidsramme: the 3rd day after the surgery	the 3rd day after the surgery
CSF neuron specific enolase, Tidsramme: immediately the end of surgery	immediately the end of surgery
CSF neuron specific enolase, Tidsramme: the 1st day after the surgery	the 1st day after the surgery
CSF neuron specific enolase, Tidsramme: the 2nd day after the surgery	the 2nd day after the surgery
CSF neuron specific enolase, Tidsramme: the 3rd day after the surgery	the 3rd day after the surgery
CSF MBP Tidsramme: immediately the end of surgery	immediately the end of surgery
CSF MBP Tidsramme: the 1st day after the surgery	the 1st day after the surgery
CSF MBP Tidsramme: the 2nd day after the surgery	the 2nd day after the surgery
CSF MBP Tidsramme: the 3rd day after the surgery	the 3rd day after the surgery
CSF GFAP Tidsramme: immediately the end of surgery	immediately the end of surgery
CSF GFAP Tidsramme: the 1st day after the surgery	the 1st day after the surgery
CSF GFAP Tidsramme: the 2nd day after the surgery	the 2nd day after the surgery
CSF GFAP Tidsramme: the 3rd day after the surgery	the 3rd day after the surgery
CSF TNF-α Tidsramme: immediately the end of surgery	immediately the end of surgery
CSF TNF-α Tidsramme: the 1st day after the surgery	the 1st day after the surgery
CSF TNF-α Tidsramme: the 2nd day after the surgery	the 2nd day after the surgery
CSF TNF-α Tidsramme: the 3rd day after the surgery	the 3rd day after the surgery
CSF IL-10 Tidsramme: immediately the end of surgery	immediately the end of surgery
CSF IL-10 Tidsramme: the 1st day after surgery	the 1st day after surgery
CSF IL-10 Tidsramme: the 2nd day after surgery	the 2nd day after surgery
CSF IL-10 Tidsramme: the 3rd day after surgery	the 3rd day after surgery
CSF IL-6 Tidsramme: immediately the end of surgery	immediately the end of surgery
CSF IL-6 Tidsramme: the 1st day after surgery	the 1st day after surgery
CSF IL-6 Tidsramme: the 2nd day after surgery	the 2nd day after surgery
CSF IL-6 Tidsramme: the 3rd day after surgery	the 3rd day after surgery
CSF IL-2 Tidsramme: immediately the end of surgery	immediately the end of surgery
CSF IL-2 Tidsramme: the 1st day after surgery	the 1st day after surgery
CSF IL-2 Tidsramme: the 2nd day after surgery	the 2nd day after surgery
CSF IL-2 Tidsramme: the 3rd day after surgery	the 3rd day after surgery
SEP Tidsramme: immediately after blocking the aorta	immediately after blocking the aorta
SEP Tidsramme: immediately after opening the aorta	immediately after opening the aorta
SEP Tidsramme: immediately the end of the surgery	immediately the end of the surgery
SEP Tidsramme: the 4th hour after back to ICU	the 4th hour after back to ICU
MEP Tidsramme: immediately after blocking the aorta	immediately after blocking the aorta
MEP Tidsramme: immediately after opening the aorta	immediately after opening the aorta
MEP Tidsramme: immediately the end of the surgery	immediately the end of the surgery
MEP Tidsramme: the 4th hour after back to ICU	the 4th hour after back to ICU

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Beijing Anzhen Hospital

Efterforskere

Ledende efterforsker: WeiPing Cheng, master, Chief Physician，Professor

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2016

Primær færdiggørelse (Forventet)

1. juli 2018

Studieafslutning (Forventet)

1. september 2018

Datoer for studieregistrering

Først indsendt

25. april 2016

Først indsendt, der opfyldte QC-kriterier

12. maj 2016

Først opslået (Skøn)

17. maj 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

17. maj 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. maj 2016

Sidst verificeret

1. maj 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

WCheng 2014-8-24

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Aortadissektion

The First Hospital of Hebei Medical University

Afsluttet

Hybrid vs. konventionel kirurgi til type A aorta dissektion

Akut Stanford Type A Aorta Dissection

Kina
Ataturk University

Afsluttet

Brug af intra-aorta ballonpumpe før operation til akut myokardieinfarkt

Koronararteriesygdom | Akut myokardieinfarkt | Troponin | Koronar bypass-graftstenose af autologt kar | IABP - Lidelse af Intra-Aortic Ballon Pump

Kalkun

Kliniske forsøg med xenon

General Biophysics LLC
National Institute on Aging (NIA)

Rekruttering

Undersøgende klinisk undersøgelse for at vurdere sikkerhed og effektivitet af indånding af xenongas for at kontrollere neuroinflammation

Sund frivillig undersøgelse

Forenede Stater
Alexei Ouriadov
St. Joseph's Health Care London

Ikke rekrutterer endnu

¹²⁹Xe(XENON) MRI-program

Sunde frivillige - Mand og Kvinde

Canada
University of Kansas Medical Center
Johns Hopkins University; Baylor College of Medicine; University of Pennsylvania og andre samarbejdspartnere

Rekruttering

Hyperpolariseret 129Xe MR-lungesundhedskohorte (XeLHC)

Sund og rask

Forenede Stater
Air Liquide Santé International

Afsluttet

Sympatisk neural udstrømning under xenon-anæstesi hos mennesker

Sympatisk nervesystem

Tyskland
University of Kansas Medical Center
American Heart Association

Afsluttet

Udvikling af hyperpolariserede 129Xe MRI-biomarkører til evaluering af pulmonal arteriel hypertension

Pulmonal arteriel hypertension

Forenede Stater
University of Virginia

Rekruttering

Hyperpolariseret Xenon-129 MRI vs Xenon-133 scintigrafi

Kronisk obstruktiv lungesygdom

Forenede Stater
University of Virginia
Duke University

Rekruttering

Hyperpolariseret Xenon-129 MR billeddannelse af lungen (e-cigarette)

Brug af E-Cig

Forenede Stater
Cyclomedica Australia PTY Limited

Afsluttet

En sammenligning af Technegas og Xenon-133 Planar Lung Imaging hos forsøgspersoner henvist til Ventilationsscintigrafi

Bestemmelse af lungestruktur

Forenede Stater
Western University, Canada

Rekruttering

129 Xenon MR ved kronisk lungesygdom

Lungesygdom

Canada
Children's Hospital Medical Center, Cincinnati

Afsluttet

Hp129 Xenon Imaging og BOS i lungetransplantation

Bronchiolitis Obliterans

Forenede Stater

Cerebral and Spinal Protection of Xenon Post-conditioning in Patients Undergoing Aortic Dissection Repair

Studieoversigt

Status

Betingelser

Intervention / Behandling

Undersøgelsestype

Tilmelding (Forventet)

Fase

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal våben

Våben og indgreb

Deltagergruppe / Arm

Intervention / Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

Efterforskere

Datoer for undersøgelser

Studer store datoer

Studiestart

Primær færdiggørelse (Forventet)

Studieafslutning (Forventet)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Skøn)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Kliniske forsøg med Aortadissektion

Kliniske forsøg med xenon

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Mongolia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer