NCT03684876

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 5, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 26, 2018

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

May 17, 2023

Status Verified

May 1, 2023

Enrollment Period

6 years

First QC Date

July 5, 2018

Last Update Submit

May 16, 2023

Conditions

Cardiorenal Syndrome

Keywords

cardiac surgeryvenous congestiondiuretic depletion

Outcome Measures

Primary Outcomes (1)

  • change in renal glomerular filtration before and 6 hours after use of diurectic

    change in renal glomerular filtration before and 6 hours after use of diurectic

    at baseline (o hours) and 6 hours after use of diuretic

Interventions

diuretic usePROCEDURE

use of diuretic

Eligibility Criteria

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

patient age \>=18 years

You may qualify if:

  • patient undergoing elective cardiac surgery under cardiopulmonary bypass

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, France

RECRUITING

MeSH Terms

Conditions

Cardio-Renal SyndromeHyperemia

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesHeart FailureHeart DiseasesCardiovascular DiseasesVascular Diseases

Central Study Contacts

Osama ABOU ARAB, MD

CONTACT

33 3 22 08 78 36AbouArab.Osama@chu-amiens.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2018

First Posted

September 26, 2018

Study Start

June 1, 2018

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

May 17, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)