- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04043507
Non-Encapsulated Heme Levels in Adult Cardiac Surgery
Non-encapsulated (free) heme, a breakdown component of hemoglobin, is associated with oxidative stress and inflammation with consequent cellular and tissue injury (Ryter & Tyrrell, 2000) (D T G Wagener, et al., 2001). Cardiopulmonary bypass is known to cause trauma to cellular components of the blood, to trigger an inflammatory response, and alter the rheology of the circulation. Prior research has demonstrated an increase in levels of free heme with cardiopulmonary bypass (Wetz, Richardt, Schotola, Bauer, & Bräuer, 2017) (Kubota, Egi, & Mizobuchi, 2017). The stress response to cardiac surgery and utilization of blood salvage techniques independent of cardiopulmonary bypass may affect plasma free heme levels as well as regulation of heme metabolism pathways. It is unclear whether and to what degree plasma levels of free heme may vary at discreet time points in the perioperative period during cardiac surgery involving both cardiopulmonary bypass and "off-pump" techniques.
This is an observational, prospective cohort study in which we will assess for red blood cell trauma, free heme levels, and biomarkers for acute kidney injury at various time points throughout cardiac surgery. Urine and arterial blood samples will be collected at our routine, standard of care time points pre-, intra-, and post-operatively and in addition to the standard clinical tests that will be performed (arterial blood gas analysis and activated clotting time) several additional serum biomarkers will be analyzed. Clinical correlation will be performed with levels. Sub-analysis will be performed on the basis of off vs. on pump CABG cases and also in patient that do/not develop AKI post-operatively.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Adam B Sturdivant, MPH
- Phone Number: 205-934-4042
- Email: Adamsturdivant@uabmc.edu
Study Contact Backup
- Name: Ayesha Bryant, MD, MSPH
- Phone Number: 205-996-7383
- Email: Asbryant@uabmc.edu
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35233
- Recruiting
- University of Alabama at Birmingham
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Contact:
- Shanna Graves
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Principal Investigator:
- Benjamin Tuck, MD
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Contact:
- Adam B Sturdivant, MPH
- Phone Number: 205-934-4042
- Email: Adamsturdivant@uabmc.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age >/= 18 years, Scheduled adult cardiac surgery
Exclusion Criteria:
- Age < 18 years, heart transplantation, presence of preoperative ventricular assist device
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Red Blood Cell Stability
Time Frame: This outcome will be measured by analyzing the difference in heme levels after surgery to the levels of heme before the surgery. Generally, this time frame would be no greater than from one hour prior to induction to one hour post operation.
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We will be looking at the level of red blood cell damage that occurs during cardiac surgery.
This will be examined by measuring the level of non-encapsulated heme levels in enrolled patients.
The concept is that the body can respond to a certain amount of heme, which is a component of hemoglobin that rises as red blood cells are damaged in vivo.
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This outcome will be measured by analyzing the difference in heme levels after surgery to the levels of heme before the surgery. Generally, this time frame would be no greater than from one hour prior to induction to one hour post operation.
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Collaborators and Investigators
Investigators
- Principal Investigator: Benjamin Tuck, MD, University of Alabama at Birmingham
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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