Evaluation of Microcirculatory Function and Mitochondrial Respiration After Cardiovascular Surgery

NCT05330676 | Completed Results

• 2 other identifiers: 843614KL2TR001879
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Shock; Cardiovascular Diseases; Critical Illness

Keywords

microcirculation; mitochondrial respiration; circulatory shock; cardiovascular surgery; resuscitation

Outcome Measures

Primary Outcomes (1)

• Perfused Vessel Denisty (PVD)

  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.

Study Arms (2)

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

Shock

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

Procedure: coronary artery bypass grafting, valve repair/replacement

Interventions

coronary artery bypass grafting, valve repair/replacement PROCEDURE

cardiovascular surgery with cardiopulmonary bypass

No shock; Shock

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with cardiovascular disease

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 38578158 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood mononuclear cells, plasma

MeSH Terms

Conditions

Shock; Cardiovascular Diseases; Critical Illness

Interventions

Coronary Artery Bypass; Replantation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Thoracic Surgical Procedures; Transplantation

Results Point of Contact

• Title: John C. Greenwood, MD, MS
• Organization: University of Pennsylvania

john.greenwood@pennmedicine.upenn.edu

856-816-7172

Study Officials

• John C. Greenwood

  Perelman School of Medicine at the University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Emergency Medicine, Anesthesiology & Critical Care

Study Record Dates

• First Submitted: April 9, 2022
• First Posted: April 15, 2022
• Study Start: September 1, 2020
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: May 2, 2024
• Results First Posted: May 2, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

US (1)