Evaluation of Microcirculatory Function and Mitochondrial Respiration After Cardiovascular Surgery

NCT ID: NCT05330676

Last Updated: 2024-05-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

142 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2023-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will examine the differences in microcirculatory function and mitochondrial respiration in patients with shock after cardiovascular surgery.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Post-cardiotomy shock (PCS) occurs in up to 5% of cardiovascular surgeries and has an in-hospital mortality rate as high as 75%. It is unclear if patients with PCS despite achieving standard resuscitation goals have impairments in oxygen delivery or oxygen utilization. This study will examine the difference in microcirculatory function and mitochondrial respiration in patients with shock to better understand the driving mechanism of bioenergetic failure in patients with PCS.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Shock Cardiovascular Diseases Critical Illness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

No shock

Patients who have no evidence of clinical malperfusion or require vasoactive agents after cardiac surgery.

coronary artery bypass grafting, valve repair/replacement

Intervention Type PROCEDURE

cardiovascular surgery with cardiopulmonary bypass

Shock

Patients who have evidence of clinical malperfusion or require vasoactive agents after cardiac surgery.

coronary artery bypass grafting, valve repair/replacement

Intervention Type PROCEDURE

cardiovascular surgery with cardiopulmonary bypass

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

coronary artery bypass grafting, valve repair/replacement

cardiovascular surgery with cardiopulmonary bypass

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult patients (\>18 years old)
* Receiving elective coronary artery bypass graft (CABG)
* Receiving valvular surgery requiring cardiopulmonary bypass

Exclusion Criteria

* Unable to tolerate sublingual microcirculatory flow imaging (e.g., non-intubated patients dependent upon oxygen by facemask, poor mouth opening)
* receiving an emergent procedure
* have an actively treated malignancy
* mitochondrial disorder
* receiving surgery requiring deep hypothermic circulatory arrest.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

John Greenwood

Assistant Professor of Emergency Medicine, Anesthesiology & Critical Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

John C. Greenwood

Role: PRINCIPAL_INVESTIGATOR

Perelman School of Medicine at the University of Pennsylvania

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Greenwood JC, Talebi FM, Jang DH, Spelde AE, Gordon EK, Horak J, Acker MA, Kilbaugh TJ, Shofer FS, Augoustides JGT, Brenner JS, Muzykantov VR, Bakker J, Abella BS. Anaerobic Lactate Production Is Associated With Decreased Microcirculatory Blood Flow and Decreased Mitochondrial Respiration Following Cardiovascular Surgery With Cardiopulmonary Bypass. Crit Care Med. 2024 Aug 1;52(8):1239-1250. doi: 10.1097/CCM.0000000000006289. Epub 2024 Apr 5.

Reference Type DERIVED
PMID: 38578158 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KL2TR001879

Identifier Type: NIH

Identifier Source: secondary_id

View Link

843614

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cardiovascular Metabolic Remodeling in Shock
NCT06285513 NOT_YET_RECRUITING