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Completed

NCT Number: NCT05330676

Evaluation of 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.

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Key information

Conditions

Shock Cardiovascular Diseases Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

coronary artery bypass grafting, valve repair/replacement

Procedure

cardiovascular surgery with cardiopulmonary bypass

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

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

Acronym: MicroRESUS

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 15, 2022
Registry last updated
May 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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