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Trial record 37 of 312 for:    Recruiting, Not yet recruiting, Available Studies | "Spinal Cord Injuries"

Acute Cardiac Responses to Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT03143179
Recruitment Status : Not yet recruiting
First Posted : May 8, 2017
Last Update Posted : May 8, 2017
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Christopher West, University of British Columbia

Brief Summary:
The immediate period after spinal cord injury (SCI) is one of the only opportunities that clinicians and care-givers have to make a real difference to patient outcomes. One of the main aims during this period is to preserve blood flow and oxygen delivery to the spinal cord to prevent any further damage from occurring after the injury. The heart acts as the major pump for blood to be pumped to the spinal cord and the body. It has been shown in small animal models and in humans with long-standing SCI that the ability of the heart to pump blood after injury is compromised, which may in turn reduce the amount of blood and oxygen delivered to the injured cord. It is unclear how quickly these changes occur in the heart following SCI and how best to manage heart function such that blood flow and oxygen delivery can be optimized. In the present study, the investigators will examine how the heart functions immediately after SCI. The findings from this study are expected to provide new information that could help clinicians improve the management of people who have just suffered a SCI.

Condition or disease
Spinal Cord Injuries

Detailed Description:

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


Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acute Hemodynamic and Cardiac Responses to Spinal Cord Injury: A Feasibility Study
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. daily resting ejection fraction [ Time Frame: up to 3 days ]
    Index of systolic cardiac function


Secondary Outcome Measures :
  1. slope of the Starling curve [ Time Frame: up to 3 days ]
    Slope of the central venous pressure vs. cardiac output curve derived from the fluid challenge



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
10 individuals aged 18-60 who have sustained an acute traumatic SCI above T2 spinal level less than 72hours prior.
Criteria

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.

Responsible Party: Christopher West, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT03143179     History of Changes
Other Study ID Numbers: H16-00818
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System