NCT02054546

Brief Summary

The purpose of this study is to analyze the new biomarkers (TIMP-2 and IGFBP-7) of tubular renal cell damage for the prediction of the Cardiac Surgery Associated acute kidney injury.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2013

Shorter than P25 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

December 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 27, 2015

Status Verified

February 1, 2015

Enrollment Period

1 year

First QC Date

February 3, 2014

Last Update Submit

February 26, 2015

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • AKI-stadium 1 (KDIGO)

    30 days

Secondary Outcomes (1)

  • all cause mortality

    30 days

Other Outcomes (1)

  • AKI Stadium 2-3 (KDIGO)

    30 days

Eligibility Criteria

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

adults with planned cardiac surgery and cardiopulmonary bypass

You may qualify if:

  • planned cardiac surgery

You may not qualify if:

  • renal dialysis
  • minors
  • emergency
  • no cardiopulmonary bypass

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsspital Basel

Basel, Canton of Basel-City, 4056, Switzerland

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

  • Jens Fassl, MD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2014

First Posted

February 4, 2014

Study Start

December 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

February 27, 2015

Record last verified: 2015-02

Locations

CH(1)