NCT02881710

Brief Summary

Multicenter, prospective, uncontrolled study to evaluate variations in urinary concentrations of TIMP-2 and PCI IGFBP7 induced injection during a CT scan in intensive care patient.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2014

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

April 9, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 29, 2016

Completed
Last Updated

September 21, 2021

Status Verified

August 1, 2016

Enrollment Period

2 years

First QC Date

August 24, 2016

Last Update Submit

September 20, 2021

Conditions

Emergency

Outcome Measures

Primary Outcomes (1)

  • significant increase in urinary concentrations of TIMP-2 and IGFBP7 defined as an increase of NephroCheck® test of more than 0.2 [ng / mL] 2/1000) after PCI injection

    follow up: 5 days after injection

Interventions

contrast product used to assess biomarkers variationsOTHER

Eligibility Criteria

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

Medical and surgical intensive care adult patients undergoing CT with PCI intravenous injection.

You may qualify if:

  • Patients aged 18 years or more,
  • Hospitalized in intensive care,
  • Holders of a urinary catheter
  • Patient receiving a first CT with intravenous injection of PCI during their ICU stay.
  • Patient agreeing to participate in the research protocol

You may not qualify if:

  • Anuria
  • Need to retain urine, whatever the reason (eg measurement of 24-hour proteinuria).
  • Urine unanalyzable whatever reason (eg urinary washing with double current probe, injection is saline to measure bladder pressure.).
  • Patient subjected to renal replacement
  • Patient already included in the study for a previous injection of PCI in intensive care.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

August 24, 2016

First Posted

August 29, 2016

Study Start

April 9, 2014

Primary Completion

March 27, 2016

Study Completion

March 27, 2016

Last Updated

September 21, 2021

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share