Association Between Renal and Right Cardiac Functions After Urinary Sodium Depletion Following Cardiac Surgery (DECONGEST)

May 16, 2023 updated by: Centre Hospitalier Universitaire, Amiens

Association Between Renal and Right Cardiac Functions After Urinary Sodium Depletion Following Cardiac Surgery: a Prospective Observational Study

Following cardiac surgery, right ventricular function may be altered leading to increase central venous pressure and decrease in renal blood flow. The investigator's standard care includes use of diuretic to avoid interstitial fluid accumulation. The aim of the study is to assess cardiac and renal function before and after depletion by using diuretics

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will compare cardiac and renal data before and 6 hours after use of diuretic

  • Echocardiographic measure of right function (S wave, TAPSE, ventricle surfaces, inferior vena cava diameter) and left function (LVEF, cardiac output
  • Renal function: cumulative diuresis, creatinine level variation and incidence of acute kidney injury using KDIGO classification (creatinine level>26.5 or diuresis<0.05 ml kg-1 h-1)

Study Type

Observational

Enrollment (Anticipated)

40

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

patient age >=18 years

Description

Inclusion Criteria:

patient undergoing elective cardiac surgery under cardiopulmonary bypass

Exclusion Criteria:

  • heart transplantation
  • use of vasopressor
  • chronic renal disease (DGF under 30 ml min-1)
  • endocarditis
  • patient under ECLS or CPIA
  • patient under 18-year-old

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in renal glomerular filtration before and 6 hours after use of diurectic
Time Frame: at baseline (o hours) and 6 hours after use of diuretic
change in renal glomerular filtration before and 6 hours after use of diurectic
at baseline (o hours) and 6 hours after use of diuretic

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire, Amiens

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)

June 1, 2018

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

July 5, 2018

First Submitted That Met QC Criteria

September 25, 2018

First Posted (Actual)

September 26, 2018

Study Record Updates

Last Update Posted (Actual)

May 17, 2023

Last Update Submitted That Met QC Criteria

May 16, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI 2018_843_012

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

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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