NCT06565403

Brief Summary

The aim of the research is to determine the prevalence of patients with acute kidney injury in the intensive care unit, the role of dialysis treatment in the treatment of these patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2024

Completed
Last Updated

August 23, 2024

Status Verified

August 1, 2024

Enrollment Period

1.1 years

First QC Date

August 19, 2024

Last Update Submit

August 21, 2024

Conditions

Keywords

acute kidney injurylactateacidosissurvival

Outcome Measures

Primary Outcomes (1)

  • Hyperlactatemia in critically ill patients with acute kidney injury treated with renal replacement therapy in the intensive care unit

    survival

    90 days

Eligibility Criteria

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

All critically ill patients with stage 3 AKI who received RRT were included in the final study cohort.

You may qualify if:

  • age \>18 years,
  • presence of acute kidney injury, stage 3 according to Kidney Disease:Improving Global Outcomes (KDIGO) criteria
  • treatment with renal replacement therapy (RRT)

You may not qualify if:

  • patients with chronic kidney disease (CKD) receiving chronic RRT
  • previous known malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert Ekart

Maribor, 2000, Slovenia

Location

Related Publications (1)

  • Ekart R, Kobal B, Korosec T, Jakopin E, Svensek F, Piko N, Bevc S, Hojs R. Hyperlactatemia in critically ill patients with acute kidney injury treated with renal replacement therapy in the intensive care unit. BMC Nephrol. 2025 Apr 30;26(1):217. doi: 10.1186/s12882-025-04149-5.

MeSH Terms

Conditions

Acute Kidney InjuryAcidosis

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.Robert Ekart, MD, PhD

Study Record Dates

First Submitted

August 19, 2024

First Posted

August 22, 2024

Study Start

November 15, 2022

Primary Completion

December 23, 2023

Study Completion

August 19, 2024

Last Updated

August 23, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

There is a plan to make statistical data analysis available.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
One year.
Access Criteria
The member of the research team.

Locations