Evaluation of Microcirculatory Function and Mitochondrial Respiration After Cardiovascular Surgery (MicroRESUS)

May 1, 2024 updated by: John Greenwood, University of Pennsylvania

The MicroRESUS Study: An Observational Study to Examine the Effects of Circulatory Shock and Resuscitation on Microcirculatory Function and Mitochondrial Respiration After Cardiovascular Surgery.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

142

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with cardiovascular disease

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
No shock
Patients who have no evidence of clinical malperfusion or require vasoactive agents after cardiac surgery.
Procedure: coronary artery bypass grafting, valve repair/replacement
cardiovascular surgery with cardiopulmonary bypass
Shock
Patients who have evidence of clinical malperfusion or require vasoactive agents after cardiac surgery.
Procedure: coronary artery bypass grafting, valve repair/replacement
cardiovascular surgery with cardiopulmonary bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perfused Vessel Denisty (PVD)
Time Frame: PVD was measured at baseline (immediately prior to surgery), at ICU admission, approximately 4 hours after surgery, then at 24 hours.
Perfused vessel density (PVD) was measured with incident darkfield microscopy (units mm/mm^2)
PVD was measured at baseline (immediately prior to surgery), at ICU admission, approximately 4 hours after surgery, then at 24 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

National Center for Advancing Translational Sciences (NCATS)

Investigators

  • Principal Investigator: John C. Greenwood, Perelman School of Medicine at the University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

April 1, 2023

Study Completion (Actual)

April 1, 2023

Study Registration Dates

First Submitted

April 9, 2022

First Submitted That Met QC Criteria

April 9, 2022

First Posted (Actual)

April 15, 2022

Study Record Updates

Last Update Posted (Estimated)

May 2, 2024

Last Update Submitted That Met QC Criteria

May 1, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 843614
  • KL2TR001879 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The protocol for this trial will be published in a peer reviewed journal. The anonymized dataset supporting the results of this report will be available via the Zenodo research data repository.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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