Evaluation of the Renal Congestion, Perfusion and Functio... | NCT03704844

Studies
Evaluation of the Renal Congestion, Perfusion and Function Before and After Diuretic Treatment in the ICU

NCT03704844

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

May 1, 2019Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Renal Congestion

Interventions

non applicable

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2018Actual

Primary Completion Date

Dec 2021Estimated

Completion Date

Dec 2021Estimated

First Submitted Date

Jul 30, 2018

First Submission Date that Met QC Criteria

Oct 12, 2018

First Posted Date

Oct 15, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2019

Last Update Posted Date

May 1, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with renal congestion			Other: non applicable
Patients without renal congestion			Other: non applicable

Interventions

Name	Type	Description	Arm Group Labels	Other Names
non applicable	Other	non applicable	Patients with renal congestion Patients without renal congestion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effects of diuretics	Evaluation of renal perfusion diuretic treatment by measuring the renal resistance index and the renal venous impedance index.	24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patient hospitalized in ICU
under furosemide treatment

Exclusion Criteria:

participation refusal
uncontrolled shock (MAP<65mmHg)
abdominal compartment syndrome
diuretic administration in the 6 hours prior to inclusion
renal replacement therapy or stage 4-5 chronic kidney disease
atrial fibrillation
no monitoring of CVP / invasive arterial pressure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

ICU patients under treatment by furosemide

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Amiens-Picardie	Not yet recruiting	Amiens		80054	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided