Cardiac Surgery With Cardiopulmonary BypassNCT06895213
Evaluation of Plasma Renin Concentrations in Cardiac Surgery
An observational study of Cardiac Surgery With Cardiopulmonary Bypass, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to learn more about how renin (a blood test) is affected by cardiopulmonary bypass, the heart-lung machine used during open heart surgery. Renin is a protein that may be elevated in response to low blood pressure or situations where organs do not receive sufficient oxygen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery With Cardiopulmonary Bypass
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult persons 18 years of age or greater (female and male).
Who may be able to join
- Adult persons 18 years of age or greater.
- Scheduled for an elective cardiac surgical procedure involving the use of cardiopulmonary bypass.
Who cannot join
- Surgery involving heart or lung transplantation or implant of a durable left ventricular assist device.
- Emergency cardiac surgery.
- Established diagnosis of any congenital heart disease.
- End-stage kidney disease receiving kidney replacement therapy before surgery.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research is to learn more about how renin (a blood test) is affected by cardiopulmonary bypass, the heart-lung machine used during open heart surgery. Renin is a protein that may be elevated in response to low blood pressure or situations where organs do not receive sufficient oxygen. Renin may potentially be used as an indicator for specific treatments aimed to increase the blood pressure. This study will evaluate blood samples for renin concentration throughout the course of open heart surgery.
Read the detailed description
The investigator hypothesizes that renin concentrations will increase with exposure to cardiopulmonary bypass and that increased renin concentrations will be associated with the development of vasoplegia.
Specific Aim 1. To characterize the effects of cardiopulmonary bypass on plasma renin concentrations in adults undergoing cardiac surgery.
Specific Aim 2. To test the prognostic value of plasma renin concentrations on outcomes following cardiac surgery.
- Keywords
- renin-angiotensin system, RAS, hypotension, perfusion, shock, blood pressure
- Medical subject headings
- Hypotension, Shock
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma renin concentrations
Measured: Up to 24 hours after surgery
Secondary outcomes (4)
Vasoplegia
Requirement of any vasopressor to maintain a mean arterial pressure of 65 mmHg or greater despite a cardiac index of at least 2.2 L/min/m2 with or without the need for pharmacologic inotropy
Measured: First 24 hours postoperative
Acute kidney injury
Assessed by the Kidney Disease Improving Global Outcomes (KDIGO) staging criteria
Measured: 7 days
Organ dysfunction
The presence of any organ support therapy including vasopressors, renal replacement therapy, and mechanical ventilation
Measured: 28 days
Mortality
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start14 Apr 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgery With Cardiopulmonary BypassStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick M. Wieruszewski, Pharm.D., Mayo Clinic
- Investigators
- Patrick M Wieruszewski, Pharm.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895213
- Sponsor's protocol ID
- 24-004256
- Status last verified
- Aug 2026
- First submitted
- 13 Mar 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Plasma Renin Concentrations in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06895213
- Acronym / sponsor ID
- 24-004256
- Keywords
- renin-angiotensin system, RAS, hypotension, perfusion, shock, blood pressure
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to learn more about how renin (a blood test) is affected by cardiopulmonary bypass, the heart-lung machine used during open heart surgery. Renin is a protein that may be elevated in response to low blood pressure or situations where organs do not receive sufficient oxygen. Renin may potentially be used as an indicator for specific treatments aimed to increase the blood pressure. This study will evaluate blood samples for renin concentration throughout the course of open heart surgery.
Detailed description
The investigator hypothesizes that renin concentrations will increase with exposure to cardiopulmonary bypass and that increased renin concentrations will be associated with the development of vasoplegia.
Specific Aim 1. To characterize the effects of cardiopulmonary bypass on plasma renin concentrations in adults undergoing cardiac surgery.
Specific Aim 2. To test the prognostic value of plasma renin concentrations on outcomes following cardiac surgery.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult persons 18 years of age or greater (female and male).
Key inclusion criteria (2 listed)
- Adult persons 18 years of age or greater.
- Scheduled for an elective cardiac surgical procedure involving the use of cardiopulmonary bypass.
Key exclusion criteria (4 listed)
- Surgery involving heart or lung transplantation or implant of a durable left ventricular assist device.
- Emergency cardiac surgery.
- Established diagnosis of any congenital heart disease.
- End-stage kidney disease receiving kidney replacement therapy before surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Plasma renin concentrations
Time frame: Up to 24 hours after surgery
4 secondary outcomes
Vasoplegia
Time frame: First 24 hours postoperative
Acute kidney injury
Time frame: 7 days
Organ dysfunction
Time frame: 28 days
Mortality
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Patrick M Wieruszewski, Pharm.D. principal investigator
Mayo Clinic
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 Cardiac Surgery With Cardiopulmonary Bypass, run by Mayo Clinic 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 2 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 10 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Plasma renin concentrations (time frame: Up to 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2026.