NCT03704844

Brief Summary

Renal congestion is a pathological state that can lead to acute kidney failure. Furosemide is known to lower renal congestion by its diuretic effect. The aim of this trial is to study the reversibility of kidney congestion under diuretic therapy and assess through echodoppler parameters if it can improve renal perfusion and function in congestive ICU patients. It could in fine lead to a better identification of patients that could benefit from diuretic therapy in the ICU.

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
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2018

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

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

July 30, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 15, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

May 1, 2019

Status Verified

April 1, 2019

Enrollment Period

3 years

First QC Date

July 30, 2018

Last Update Submit

April 29, 2019

Conditions

Renal Congestion

Outcome Measures

Primary Outcomes (1)

  • Effects of diuretics

    Evaluation of renal perfusion diuretic treatment by measuring the renal resistance index and the renal venous impedance index.

    24 hours

Study Arms (2)

Patients with renal congestion

Other: non applicable

Patients without renal congestion

Other: non applicable

Interventions

non applicableOTHER

non applicable

Patients with renal congestionPatients without renal congestion

Eligibility Criteria

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

ICU patients under treatment by furosemide

You may qualify if:

  • patient hospitalized in ICU
  • under furosemide treatment

You may not qualify if:

  • participation refusal
  • uncontrolled shock (MAP\<65mmHg)
  • abdominal compartment syndrome
  • renal replacement therapy or stage 4-5 chronic kidney disease
  • atrial fibrillation
  • no monitoring of CVP / invasive arterial pressure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHU Amiens-Picardie

Amiens, 80054, France

NOT YET RECRUITING

CHU de Dijon

Dijon, 21000, France

NOT YET RECRUITING

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

RECRUITING

Study Design

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

Study Record Dates

First Submitted

July 30, 2018

First Posted

October 15, 2018

Study Start

December 1, 2018

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

May 1, 2019

Record last verified: 2019-04

Locations

FR(3)