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NCT01944605 · ClinicalTrials.gov registry record
Intestinal Ischemia as a Stimulus for Systemic Inflammatory Response After Cardiac Arrest
A clinical trial, sponsored by Virginia Commonwealth University.
- Completed
- Registry status
- 40
- Enrollment target
NCT01944605: Completed study, sponsored by Virginia Commonwealth University.
NCT01944605 is a clinical trial that has completed, run by Virginia Commonwealth University. The registered enrollment target is 40 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01944605 has completed, sponsored by Virginia Commonwealth University.
- COMPLETED
- Registry status
- 40 participants
- Enrollment target
Study Summary
Out-of-hospital cardiac arrest (CA) is a leading public health problem causing nearly one third of a million deaths annually in the US, accounting for half of all cardiovascular deaths and surpassing deaths from stroke, heart failure, and breast and lung cancer combined. Twenty to fifty percent of CA patients (pts) can be resuscitated initially but many die before hospital discharge or suffer permanent neurologic damage. Therapeutic hypothermia (TH) improves survival and neurological outcomes. Despite aggressive, targeted post arrest management, including TH, approximately 50% of pts die before leaving the hospital due to global ischemia-reperfusion injury (IRI) known as the "post arrest syndrome", 1 which is a sepsis-like state characterized by elevated markers of cellular inflammation and injury. It is believed that TH works by decreasing the body's basal metabolic rate (BMR) and attenuating the systemic inflammatory response (SIR). However, specific triggers of the intense pro-inflammatory response are unclear. This "gap" in knowledge must be closed to identify targeted therapy to decrease IRI and improve outcomes. Blood flow to the gut is decreased markedly and intestinal tissue becomes ischemic during CA and CPR, particularly when vasoconstrictor drugs such as epinephrine, are given. IRI of the intestine increases intestinal permeability leading to intestinal microbial translocation and endotoxin release that can stimulate and perpetuate systemic inflammation and cause subsequent multi-organ dysfunction. Endotoxin also increases body temperature and energy expenditure and may attenuate TH induced reductions in BMR and hence, decrease efficacy. The purpose of this novel pilot study is to detect systemic endotoxin release following CA in humans and determine association with cytokine activation, and BMR alterations during TH.
Primary Outcome
Endotoxin activity will be measured by the Endotoxin Activity Assay and values . of \>0.4 EA units will be used as the "cut-off" for the presence of pathological endotoxin.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2013-09 |
| Est. Completion | 2014-03-30 |
What the finished NCT01944605 record still lists
NCT01944605 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 40 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01944605 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01944605 about?
NCT01944605 is a clinical study titled "Intestinal Ischemia as a Stimulus for Systemic Inflammatory Response After Cardiac Arrest". Out-of-hospital cardiac arrest (CA) is a leading public health problem causing nearly one third of a million deaths annually in the US, accounting for half of all cardiovascular deaths and surpassing deaths from stroke, heart failure, and breast and lung cancer combined. Twenty to fifty percent of C...
What is the current status of trial NCT01944605?
This trial is currently completed. The enrollment target is 40 participants. The study started on 2013-09. Estimated completion is 2014-03-30.
Who is sponsoring clinical trial NCT01944605?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
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