Evaluation of Plasma Renin Concentrations in Cardiac Surgery

May 12, 2026 updated by: Patrick M. Wieruszewski, Pharm.D., Mayo Clinic
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult persons 18 years of age or greater (female and male).

Description

Inclusion Criteria:

  • Adult persons 18 years of age or greater.
  • Scheduled for an elective cardiac surgical procedure involving the use of cardiopulmonary bypass.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma renin concentrations
Time Frame: Up to 24 hours after surgery
Up to 24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 28 days
28 days
Vasoplegia
Time Frame: First 24 hours postoperative
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
First 24 hours postoperative
Acute kidney injury
Time Frame: 7 days
Assessed by the Kidney Disease Improving Global Outcomes (KDIGO) staging criteria
7 days
Organ dysfunction
Time Frame: 28 days
The presence of any organ support therapy including vasopressors, renal replacement therapy, and mechanical ventilation
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Patrick M Wieruszewski, Pharm.D., Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

March 13, 2025

First Submitted That Met QC Criteria

March 24, 2025

First Posted (Actual)

March 26, 2025

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-004256

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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