Evaluation of Plasma Renin Concentrations in Cardiac Surgery

Recruiting

• Conditions: Cardiac Surgery With Cardiopulmonary Bypass

• Registration Number: NCT06895213
• Lead Sponsor: Mayo Clinic

Brief 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. 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 Timeline

• Study First Submitted: 2025-03-13
• Study First Submitted QC: 2025-03-24
• Study First Posted: 2025-03-26
• Study Start: 2025-04-14
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-09
• Primary Completion: 2026-04
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma renin concentrations	Up to 24 hours after surgery

Secondary Outcome Measures

Name	Time	Method
Vasoplegia	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
Acute kidney injury	7 days	Assessed by the Kidney Disease Improving Global Outcomes (KDIGO) staging criteria
Organ dysfunction	28 days	The presence of any organ support therapy including vasopressors, renal replacement therapy, and mechanical ventilation
Mortality	28 days

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States