NCT02894164

Brief Summary

This is a cohort study in which patients who survive Acute Kidney Injury (AKI) during intensive care unit (ICU) admission are recalled at 3-6 months and renal function tests are performed. The purpose of the study is describe renal function in AKI survivors at follow-up. Additional aims are to determine how well admission values of renal function markers perform as predictors of renal function at follow-up and whether estimates of renal function at follow-up differ depending on which renal function marker is used.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
336

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
Last Updated

August 23, 2017

Status Verified

August 1, 2017

Enrollment Period

3.9 years

First QC Date

September 5, 2016

Last Update Submit

August 22, 2017

Conditions

Keywords

Cystatin CCreatinineGlomerular Filtration Rate

Outcome Measures

Primary Outcomes (1)

  • Renal function

    Renal function as defined by estimated glomerular filtration rate (eGFR)using seri Creatinine and Cystatin C at follow-up

    3-9 months

Secondary Outcomes (1)

  • Mortality

    2 years

Interventions

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to the central intensive care unit at Karolinska University hospital, who suffered from AKI during the period September 2008 until May 2011.

You may qualify if:

  • Adults treated on Intensive care with AKI (RIFLE criteria)
  • Survival 3 months after discharge.
  • Admission during September 2008-May 2011

You may not qualify if:

  • Under 18 years
  • Unable to give consent.
  • Admission during a time when study staff not working.
  • Death before 3 month follow-up
  • No Swedish personal identification number

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institute

Stockholm, 171 77, Sweden

Location

Related Publications (1)

  • Bellomo R, Ronco C, Kellum JA, Mehta RL, Palevsky P; Acute Dialysis Quality Initiative workgroup. Acute renal failure - definition, outcome measures, animal models, fluid therapy and information technology needs: the Second International Consensus Conference of the Acute Dialysis Quality Initiative (ADQI) Group. Crit Care. 2004 Aug;8(4):R204-12. doi: 10.1186/cc2872. Epub 2004 May 24.

    PMID: 15312219BACKGROUND

MeSH Terms

Conditions

Acute Kidney InjuryRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Max Bell, PhD

    Karolinska Institutet

    STUDY DIRECTOR
  • Johan Mårtensson, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR
  • Claes-Roland Martling, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

September 5, 2016

First Posted

September 9, 2016

Study Start

January 1, 2008

Primary Completion

December 1, 2011

Study Completion

December 1, 2014

Last Updated

August 23, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Data is anonymised and data regarding individuals will not be published.

Locations