ShockMicroRESUSNCT05330676

Evaluation of Microcirculatory Function and Mitochondrial Respiration After Cardiovascular Surgery

An observational study of Shock and Cardiovascular Diseases, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Shock, Cardiovascular Diseases, Critical Illness
What is being tested?: coronary artery bypass grafting, valve repair/replacement
Type of treatment: Surgery or procedure
How many people: 142 participants
Where: 1 siteUnited States
Study dates: 1 Sep 2020to 1 Apr 2023
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients with cardiovascular disease

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official 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.

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

Read the 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.

Conditions: Shock, Cardiovascular Diseases, Critical Illness
Being tested: coronary artery bypass grafting, valve repair/replacement
Keywords: microcirculation, mitochondrial respiration, circulatory shock, cardiovascular surgery, resuscitation
Medical subject headings: Shock, Cardiovascular Diseases, Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

coronary artery bypass grafting, valve repair/replacementProcedure or surgery
cardiovascular surgery with cardiopulmonary bypass

Study groups in NCT05330676
Study group	Role	What they receive
No shock		Patients who have no evidence of clinical malperfusion or require vasoactive agents after cardiac surgery. Receives: Procedure: coronary artery bypass grafting, valve repair/replacement
Shock		Patients who have evidence of clinical malperfusion or require vasoactive agents after cardiac surgery. Receives: Procedure: coronary artery bypass grafting, valve repair/replacement

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 20201 Apr 2023

First posted15 Apr 2022
Study start1 Sep 2020
Primary completion1 Apr 2023
Study completion1 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for ShockStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 142 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05330676
Sponsor's protocol ID: 843614
Other IDs: KL2TR001879
Acronym: MicroRESUS
Status last verified: May 2024
First submitted: 9 Apr 2022
Last updated: 2 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

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.
PubMed 38578158

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
Hemophagocytic Lymphohistiocytosis (HLH) Evaluation and Research of Clinical, ImmUnoLogic and TranscriptomE Study
Lymphohistiocytosis, Hemophagocytic, Secondary Hemophagocytic Lymphohistiocytosis
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome

All Shock trials

Study at a glance

From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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.
ClinicalTrials.gov ID: NCT05330676
Acronym / sponsor ID: MicroRESUS / 843614
Conditions: Shock, Cardiovascular Diseases, Critical Illness
Keywords: microcirculation, mitochondrial respiration, circulatory shock, cardiovascular surgery, resuscitation
Study type: Observational
Recruitment status: Completed
Enrolment: 142 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: National Center for Advancing Translational Sciences (NCATS)
Study start: 1 Sep 2020 (actual)
Primary completion: 1 Apr 2023 (actual)
Study completion: 1 Apr 2023 (actual)
First posted: 15 Apr 2022 (actual)
Results: Posted 2 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
No shock	–	Procedure: coronary artery bypass grafting, valve repair/replacementPatients who have no evidence of clinical malperfusion or require vasoactive agents after cardiac surgery.
Shock	–	Procedure: coronary artery bypass grafting, valve repair/replacementPatients who have evidence of clinical malperfusion or require vasoactive agents after cardiac surgery.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with cardiovascular disease

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
coronary artery bypass grafting, valve repair/replacementcardiovascular surgery with cardiopulmonary bypass	Procedure or surgery	No shock, Shock

Primary outcome

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)

Results and safety

Results posted to the registry on 2 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Prolonged Organ Dysfunction	38	36
No Prolonged Organ Dysfunction	104	95

Primary outcome: 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.. Mean (Standard Deviation). Unit: mm/mm^2

Measure	Prolonged Organ Dysfunction n = 36	No Prolonged Organ Dysfunction n = 95
Baseline	22.8 (4.9)	23.8 (5.2)
ICU Admission	20.2 (3.7)	22.5 (4.7)
4-hours after surgery	21.1 (3.9)	22.8 (4.9)
24-hours	22.3 (5.0)	23.8 (5.2)

Population analysed: Patient met criteria for the primary outcome if they had 28 vasoactive and ventilator free days (VVFDs) or more at postoperative day 30.

Adverse events

Time frame: Duration of in-hospital stay, an average of 10 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Prolonged Organ Dysfunction	0 of 36 (0%)	0 of 36 (0%)	3 of 36
No Prolonged Organ Dysfunction	0 of 95 (0%)	0 of 95 (0%)	5 of 95

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38578158Greenwood 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.
Individual participant dataSharing planned: Yes. 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.

Related trials for Shock

Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
Hemophagocytic Lymphohistiocytosis (HLH) Evaluation and Research of Clinical, ImmUnoLogic and TranscriptomE Study
Lymphohistiocytosis, Hemophagocytic, Secondary Hemophagocytic Lymphohistiocytosis
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John C. Greenwood principal investigator

Perelman School of Medicine at the University of Pennsylvania

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Shock and Cardiovascular Diseases, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05330676, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024.