NCT04622384

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

October 26, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

March 21, 2024

Status Verified

March 1, 2024

Enrollment Period

2.2 years

First QC Date

October 26, 2020

Last Update Submit

March 20, 2024

Conditions

Keywords

UltrasoundRenal Replacement TherapyDialysisRenal Doppler Ultrasound

Outcome Measures

Primary Outcomes (1)

  • 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 (6)

  • Renal Doppler arterial Resistive Index (RI)

    Measured at the beginning of weaning and after 6 hours.

  • Renal Doppler Renal Venous Stasis Index (RVSI)

    Measured at the beginning of weaning and after 6 hours.

  • Renal Doppler Venous Impedance Index (VII)

    Measured at the beginning of weaning and after 6 hours.

  • Portal vein Doppler Pulsatility Fraction PF)

    Measured at the beginning of weaning and after 6 hours.

  • Urine Output

    4 days

  • +1 more secondary outcomes

Study Arms (1)

ICU patients

Patients who are treated with dialysis as CRRT and planned to undergo dialysis weaning.

Other: Dialysis weaning

Interventions

Dialysis weaning as planned by the attending ICU-physician.

ICU patients

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital, Department of Anaesthesiology

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Peter Juhl-Olsen, MD, PhD

    Aarhus University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 26, 2020

First Posted

November 10, 2020

Study Start

January 1, 2021

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

March 21, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations