Non-Encapsulated Heme Levels in Adult Cardiac Surgery

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Recruiting
CT.gov ID
NCT04043507
Collaborator
(none)
60
1
43
1.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Sample Collection

Detailed Description

Previous investigations have demonstrated increased levels of free heme in patients undergoing coronary artery bypass grafting utilizing cardiopulmonary bypass. There is evidence of an association between elevations in free heme levels and risk of developing acute kidney injury. The degree of alterations in free heme levels and the heme metabolism pathway in patients undergoing valvular repair or replacement, durable mechanical ventricular assist device placement, or aortic aneurysm repair has not been well characterized. Furthermore, free heme levels after coronary artery bypass grafting without utilization of cardiopulmonary bypass have not been described previously. Cell salvage techniques independent of cardiopulmonary bypass are known to be potentially traumatic to the cellular components of blood and this relationship has not been thoroughly explored in the cardiac surgery population. Lastly, there is scarce prior work attempting to assess the interplay between free heme levels and novel biomarkers of acute kidney injury.

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Non-Encapsulated Heme Levels in Adult Cardiac Surgery
Actual Study Start Date :
Jun 1, 2019
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Outcome Measures

Primary Outcome Measures

  1. Red Blood Cell Stability [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.]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age >/= 18 years, Scheduled adult cardiac surgery
Exclusion Criteria:
  • Age < 18 years, heart transplantation, presence of preoperative ventricular assist device

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham Birmingham Alabama United States 35233

Sponsors and Collaborators

  • University of Alabama at Birmingham

Investigators

  • Principal Investigator: Benjamin Tuck, MD, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Benjamin C. Tuck, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT04043507
Other Study ID Numbers:
  • Free-Heme
First Posted:
Aug 2, 2019
Last Update Posted:
Oct 26, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Benjamin C. Tuck, Principal Investigator, University of Alabama at Birmingham

Study Results

No Results Posted as of Oct 26, 2021