Evaluation of Plasma Renin Concentrations in Cardiac Surgery | NCT06895213

Studies
Evaluation of Plasma Renin Concentrations in Cardiac Surgery

NCT06895213

Sponsor

Mayo Clinic

Status

Recruiting

Last Update Posted

May 13, 2026Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Cardiac Surgery With Cardiopulmonary Bypass

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 14, 2025Actual

Primary Completion Date

Jul 2026Estimated

Completion Date

Jul 2026Estimated

First Submitted Date

Mar 13, 2025

First Submission Date that Met QC Criteria

Mar 24, 2025

First Posted Date

Mar 26, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2026

Last Update Posted Date

May 13, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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	First 24 hours postoperative
Acute kidney injury

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Patrick M Wieruszewski, Pharm.D.	Contact	507-255-5732		wieruszewski.patrick@mayo.edu

Overall Officials

Name	Affiliation	Role
Patrick M Wieruszewski, Pharm.D.	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic	Recruiting	Rochester	Minnesota	55905	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007022	Hypotension
D012769	Shock

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

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