NCT02961478

Brief Summary

IOXSOR study's purpose to determine the frequency of non resolutive renal failure (estimated by the clearance of iohexol) at end of stay in ICU patients who have had acute renal failure episode.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2017

Typical duration for phase_3

Geographic Reach
1 country

5 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

November 3, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 11, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

February 10, 2017

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 19, 2019

Status Verified

March 1, 2019

Enrollment Period

3.3 years

First QC Date

November 3, 2016

Last Update Submit

March 15, 2019

Conditions

Acute Renal Failure

Outcome Measures

Primary Outcomes (1)

  • Frequency of patients with a clearance of iohexol < 60 ml/min/1m273 at the end of ICU hospitalisation.

    Iohexol clearance pharmacokinetics

    24 hours

Secondary Outcomes (3)

  • Correlation between non resolutive renal at the end of ICU (iohexol clearance < 60 ml/min/1m273) and creatinine clearance < 60 ml/min/1m273 at 6 month after ICU. discharge

    Six month after ICU discharge

  • Number of risk factors associated with non resolutive among : Age Previous renal function Comorbidities Severity parameters of renal aggression Acute severity of parameters during the ICU hospitalisation

    24 hours

  • Correlation between serum creatinine derived measurements of Glomerular Filtratio Rate and iohexol clearance.

    24 hours

Study Arms (1)

Iohexol plasmatic clearance

EXPERIMENTAL
Drug: IOHEXOL

Interventions

IOHEXOLDRUG

Estimate iohexol clearance at the end of stay in intensive care for patients who had an episode of acute renal failure.

Also known as: Omnipaque ®
Iohexol plasmatic clearance

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ICU stay \> 7 days
  • Having presented during the stay renal failure stage 2 or 3 Kidney Disease Improving Global Outcomes (KDIGO)
  • Steady improvement of renal function before the ICU discharge :
  • Creatinine before ICU discharge \<110 µmol / L for women, \<130 µmol / L for men
  • No recourse to extra renal purification
  • Change in creatinine levels (ΔCréatinine) less than 20% over two measures spaced 24 hours within 48 hours preceding the discharge
  • Expected discharge ICU within 48 hours :
  • Glasgow score \> 13
  • Lack of mechanical ventilation except home Noninvasive Mechanical Ventilation (NiMV)
  • Lack of use of catecholamine
  • No contra-indication for discharge according to physician in charge of the patient
  • Informed consent signed by the patient, where not possible by the person of trust or the family if present. Written consent by the patient will be obtained as soon as deemed possible.

You may not qualify if:

  • Known medical history of immediate allergic or delayed skin allergic reaction to injection of iodinated contrast material or any serious doubt on this medical history
  • Patient receiving from extra renal purification during ICU discharge
  • Chronic renal disease known (creatinine\> 110 µmol / L for women,\> 130 µmol / L for men) or creatinine clearance estimated less than 60 mL / min
  • Pregnancy or breastfeeding women
  • Patient limitation care
  • Person not affiliated or not the beneficiary of a social security scheme

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University Hospital

Angers, France

RECRUITING

Hospital center

Chartres, France

RECRUITING

Hospital

Le Mans, France

NOT YET RECRUITING

University Hospital

Poitiers, France

RECRUITING

University Hospital

Tours, France

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Iohexol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Triiodobenzoic AcidsIodobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • François BELONCLE, CCU-AH

    University Hospital, Angers

    PRINCIPAL INVESTIGATOR

Central Study Contacts

François BELONCLE, CCU-AH

CONTACT

0241353845Francois.Beloncle@chu-angers.fr

Nicolas LEROLLE, MD PhD

CONTACT

0241353845NiLerolle@chu-angers.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2016

First Posted

November 11, 2016

Study Start

February 10, 2017

Primary Completion

June 1, 2020

Study Completion

December 1, 2020

Last Updated

March 19, 2019

Record last verified: 2019-03

Locations

FR(5)