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- Essai clinique NCT03143179
Acute Cardiac Responses to Spinal Cord Injury
Acute Hemodynamic and Cardiac Responses to Spinal Cord Injury: A Feasibility Study
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Background:
The hemodynamic management of the cervical/high-thoracic spinal cord injured patient represents a remarkably complex clinical scenario, but represents one of the only potentially neuroprotective therapeutic options currently available to the clinician. Presently, the singular goal of hemodynamic management is to increase mean arterial blood pressure (MAP) to 85mmHg by targeting peripheral tone via vasopressor therapy, with a view to increasing perfusion of the spinal cord, preventing ischemia at the injury site, and optimizing neurological outcome. It is often overlooked that the instantaneous removal of descending sympathetic control at the time of SCI renders not only the vast majority of the systemic vasculature devoid of supraspinal input, but it also impairs descending control of the heart. What is yet to be considered in current hemodynamic management protocols is that immediate cardiac dysfunction secondary to impaired supraspinal control of the heart may very well be a significant contributor to poor spinal cord perfusion. Indeed, data collected over the last four years in rodent SCI models suggests that cardiac sympathetic decentralization is the principal cause of the low cardiac output observed in both rodents and people with chronic SCI. As such, the investigator's initiative is to provide a novel approach to hemodynamic management to a porcine model that harnesses both peripheral tone and cardiac function. The investigators believe this approach is an immediately translatable neuroprotective strategy for acute SCI.
Overview:
10 individuals aged 18-60 who have sustained an acute traumatic SCI (above T2 spinal level) less than 72 hours prior will be recruited over a period of 2 years. Recruitment will be isolated to those individuals who already have a central venous catheter and arterial line as part of standard clinical care (which actually occurs in most patients). In addition to standard clinical lines, an esophageal Doppler probe will be placed to measure aortic outflow on which beat-by-beat systolic cardiac function (i.e., stroke volume, cardiac output, ejection fraction) can be estimated. During a 120 min monitoring period, beat-by-beat dependent cardiac indices will be recorded and a modified Starling curve will be constructed by examining relationships between central venous pressure (i.e., an index of venous return) and aortic flow (i.e., an index of cardiac output). After 1hr of monitoring (Part A), a 250ml bolus of intravenous crystalloid will be infused over a 5 min period and measure beat-by-beat central venous pressure and aortic flow (stroke volume) responses (Part B). The primary outcomes are daily resting stroke volume and ejection fraction, change in stroke volume and central venous pressure (CVP) in response to fluid challenge. The secondary outcome is the slope of the Starling curve
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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Vancouver, Canada
- Recrutement
- Vancouver General Hospital
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Contact:
- Leilani Reichl
- E-mail: Leilani.Reichl@vch.ca
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Male or Female aged 18-60yrs
- Acute traumatic SCI at T2 or above within the last 72 hours
- Complete (American Spinal Injuries Association Impairment Scale (AIS) A) or incomplete (AIS B) initial designation
- Requires insertion of central venous catheter and arterial catheter as part of standard clinical care
- Able to communicate in English and provide informed consent
- in sinus rhythm.
Exclusion Criteria:
- History and/or symptoms of cardiovascular disease or cardiopulmonary problems/disease, including controlled/uncontrolled hypertension
- Historical or current nasal injury (incl. cosmetic surgery)
- Nasal polyps
- Concurrent facial trauma
- Traumatic brain injury
- Concurrent intra-aortic balloon pump
- Carcinoma/major surgery of the pharynx, larynx or esophagus
- Aneurysms of the thoracic aorta
- Tissue necrosis of the esophagus or nasal passage
- Any other medical condition that in the investigator's opinion would render the study procedures dangerous.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
daily resting ejection fraction
Délai: up to 3 days
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Index of systolic cardiac function
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up to 3 days
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
slope of the Starling curve
Délai: up to 3 days
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Slope of the central venous pressure vs. cardiac output curve derived from the fluid challenge
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up to 3 days
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- H16-00818
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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