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Recruiting NCT06895213

Evaluation of Plasma Renin Concentrations in Cardiac Surgery

Observational Cardiac Surgery With Cardiopulmonary Bypass

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cardiac Surgery With Cardiopulmonary Bypass. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Plasma renin concentrations [Time frame: Up to 24 hours after surgery]
Secondary outcome measures (4)
  • Vasoplegia [Time frame: First 24 hours postoperative]
  • Acute kidney injury [Time frame: 7 days]
  • Organ dysfunction [Time frame: 28 days]
  • Mortality [Time frame: 28 days]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

United States · 1 center
  • Mayo Clinic — Rochester

Identifiers

NCT: NCT06895213 · 24-004256

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗