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
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