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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Renal Failure
• Intervention / Treatment: Drug: IOHEXOL

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Angers, France
    • Recruiting
    • University Hospital
    • Contact: François BELONCLE, CCU-AH; Phone Number: 0241353845; Email: Francois.Beloncle@chu-angers.fr
    • Contact: Nicolas LEROLLE, MD PhD; Phone Number: 0241353845; Email: NiLerolle@chu-angers.fr
  • Chartres, France
    • Recruiting
    • Hospital Center
    • Contact: Alexandre CONIA, MD; Phone Number: 02 37 30 30 30
  • Le Mans, France
    • Not yet recruiting
    • Hospital
    • Contact: Patrice TIROT, MD; Phone Number: 02 43 43 24 58; Email: ptirot@ch-lemans.fr
  • Poitiers, France
    • Recruiting
    • University Hospital
    • Contact: René Robert, MD PhD; Phone Number: 05 49 44 43 67; Email: rene.robert@chu-poitiers.fr
  • Tours, France
    • Recruiting
    • University Hospital
    • Contact: Stephan EHRMANN, MD PhD; Phone Number: 02 47 47 38 55; Email: StephanEHRMANN@gmail.com
    • Contact: Charlotte SALMON, MD; Phone Number: 02 47 47 37 18; Email: charlotte.salmon.gandonniere@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Iohexol plasmatic clearance	Drug: IOHEXOL; Estimate iohexol clearance at the end of stay in intensive care for patients who had an episode of acute renal failure.; Other Names: Omnipaque ®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of patients with a clearance of iohexol < 60 ml/min/1m273 at the end of ICU hospitalisation.	Iohexol clearance pharmacokinetics	24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Principal Investigator: François BELONCLE, CCU-AH, University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 10, 2017
• Primary Completion (ANTICIPATED): June 1, 2020
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: November 3, 2016
• First Submitted That Met QC Criteria: November 8, 2016
• First Posted (ESTIMATE): November 11, 2016

Study Record Updates

• Last Update Posted (ACTUAL): March 19, 2019
• Last Update Submitted That Met QC Criteria: March 15, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: PHRC2015-06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No