The Performance of Renal Doppler Ultrasound in Predicting... | NCT04622384

Studies
The Performance of Renal Doppler Ultrasound in Predicting Outcome of Dialysis Weaning

NCT04622384

Sponsor

Johan Fridolf Hermansen

Status

Completed

Last Update Posted

Mar 21, 2024Actual

Enrollment

33Actual

Phase

Not provided

Conditions

Acute Kidney Injury
Acute Kidney Failure Stage 3

Interventions

Dialysis weaning

Countries

Denmark

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

Mar 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Mar 1, 2023Actual

Completion Date

Mar 1, 2023Actual

First Submitted Date

Oct 26, 2020

First Submission Date that Met QC Criteria

Nov 5, 2020

First Posted Date

Nov 10, 2020Actual

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

Mar 20, 2024

Last Update Posted Date

Mar 21, 2024Actual

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

Acute kidney injury (AKI) is a frequent problem in the intensive care unit (ICU) affecting more than 50 % of patients. AKI is associated with several adverse outcomes, including increased mortality and increased length of ICU- and hospital stay, in particular in patients requiring Renal Replacement Therapy (RRT).

Choosing the optimal time for attempting liberation from RRT is still unclear. With this study, we will describe the ability of renal ultrasound in predicting the outcome of dialysis weaning.

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

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ICU patients		Patients who are treated with dialysis as CRRT and planned to undergo dialysis weaning.	Other: Dialysis weaning

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dialysis weaning	Other	Dialysis weaning as planned by the attending ICU-physician.	ICU patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dialysis weaning	If discontinuation of Dialysis is successful or not. Successful dialysis weaning is defined as no renal replacement therapy (RRT) required within the first 7 days after stopping continuous renal replacement therapy (CRRT) and non-successful weaning as the need for RRT within the first 7 days.	7 days

Secondary Outcomes

Measure	Description	Time Frame
Renal Doppler arterial Resistive Index (RI)	Measured in the interlobar vessels	Measured at the beginning of weaning and after 6 hours.
Renal Doppler Renal Venous Stasis Index (RVSI)	Measured in the interlobar vessels

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients ≥ 18 years admitted to the ICU, Aarhus University Hospital who are treated with dialysis as continuous renal placement therapy (CRRT) and planned to undergo dialysis weaning

Exclusion Criteria:

Insufficient ultrasonographic imaging of the kidneys
Known morphological kidney disease
Previous need of chronic RRT
Prior participation in the study
Need of extracorporeal membrane oxygenation (ECMO) or other heart assist device

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

Patients admitted to the ICU, Aarhus University Hospital who are treated with dialysis as CRRT and planned to undergo dialysis weaning as determined their attending ICU physician.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Juhl-Olsen, MD, PhD	Aarhus University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University Hospital, Department of Anaesthesiology		Aarhus		8200	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided