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Measurement of Iohexol Plasma Clearance in Patients Leaving ICU After Acute Renal Failure (IOXSOR)

Primary Purpose

Acute Renal Failure

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
IOHEXOL
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Renal Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Iohexol administration within 48 hours preceding the potential inclusion (imaging examination with X-ray contrast medium injection)
  • Iohexol administration planned within 24 hours after potential inclusion in the study
  • 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 under guardianship or safeguard justice known at the time of inclusion
  • Patient limitation care
  • Person not affiliated or not the beneficiary of a social security scheme

Sites / Locations

  • University HospitalRecruiting
  • Hospital centerRecruiting
  • Hospital
  • University HospitalRecruiting
  • University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Iohexol plasmatic clearance

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 3, 2016
Last Updated
March 15, 2019
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT02961478
Brief Title
Measurement of Iohexol Plasma Clearance in Patients Leaving ICU After Acute Renal Failure
Acronym
IOXSOR
Official Title
Measurement of Iohexol Plasma Clearance in Patients Leaving ICU After Acute Renal Failure
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 10, 2017 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Renal Failure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Iohexol plasmatic clearance
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
IOHEXOL
Other Intervention Name(s)
Omnipaque ®
Intervention Description
Estimate iohexol clearance at the end of stay in intensive care for patients who had an episode of acute renal failure.
Primary Outcome Measure Information:
Title
Frequency of patients with a clearance of iohexol < 60 ml/min/1m273 at the end of ICU hospitalisation.
Description
Iohexol clearance pharmacokinetics
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
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
Time Frame
Six month after ICU discharge
Title
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
Time Frame
24 hours
Title
Correlation between serum creatinine derived measurements of Glomerular Filtratio Rate and iohexol clearance.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Iohexol administration within 48 hours preceding the potential inclusion (imaging examination with X-ray contrast medium injection) Iohexol administration planned within 24 hours after potential inclusion in the study 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 under guardianship or safeguard justice known at the time of inclusion Patient limitation care Person not affiliated or not the beneficiary of a social security scheme
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
François BELONCLE, CCU-AH
Phone
0241353845
Email
Francois.Beloncle@chu-angers.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas LEROLLE, MD PhD
Phone
0241353845
Email
NiLerolle@chu-angers.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François BELONCLE, CCU-AH
Organizational Affiliation
University Hospital, Angers
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Angers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François BELONCLE, CCU-AH
Phone
0241353845
Email
Francois.Beloncle@chu-angers.fr
First Name & Middle Initial & Last Name & Degree
Nicolas LEROLLE, MD PhD
Phone
0241353845
Email
NiLerolle@chu-angers.fr
Facility Name
Hospital center
City
Chartres
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre CONIA, MD
Phone
02 37 30 30 30
Facility Name
Hospital
City
Le Mans
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrice TIROT, MD
Phone
02 43 43 24 58
Email
ptirot@ch-lemans.fr
Facility Name
University Hospital
City
Poitiers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
René Robert, MD PhD
Phone
05 49 44 43 67
Email
rene.robert@chu-poitiers.fr
Facility Name
University Hospital
City
Tours
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephan EHRMANN, MD PhD
Phone
02 47 47 38 55
Email
StephanEHRMANN@gmail.com
First Name & Middle Initial & Last Name & Degree
Charlotte SALMON, MD
Phone
02 47 47 37 18
Email
charlotte.salmon.gandonniere@gmail.com

12. IPD Sharing Statement

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Measurement of Iohexol Plasma Clearance in Patients Leaving ICU After Acute Renal Failure

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