NCT06895213

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 26, 2025

Completed
19 days until next milestone

Study Start

First participant enrolled

April 14, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

May 9, 2025

Status Verified

May 1, 2025

Enrollment Period

12 months

First QC Date

March 13, 2025

Last Update Submit

May 8, 2025

Conditions

Cardiac Surgery With Cardiopulmonary Bypass

Keywords

renin-angiotensin systemRAShypotensionperfusionshockblood pressure

Outcome Measures

Primary Outcomes (1)

  • Plasma renin concentrations

    Up to 24 hours after surgery

Secondary Outcomes (4)

  • Vasoplegia

    First 24 hours postoperative

  • Acute kidney injury

    7 days

  • Organ dysfunction

    28 days

  • Mortality

    28 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

HypotensionShock

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Patrick M Wieruszewski, Pharm.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick M Wieruszewski, Pharm.D.

CONTACT

507-255-5732wieruszewski.patrick@mayo.edu

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesiology

Study Record Dates

First Submitted

March 13, 2025

First Posted

March 26, 2025

Study Start

April 14, 2025

Primary Completion

April 1, 2026

Study Completion

May 1, 2026

Last Updated

May 9, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)