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

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ClinicalTrials.gov Identifier: NCT02961478
Recruitment Status : Recruiting
First Posted : November 11, 2016
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

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.

Condition or disease Intervention/treatment Phase
Acute Renal Failure Drug: IOHEXOL Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Measurement of Iohexol Plasma Clearance in Patients Leaving ICU After Acute Renal Failure
Actual Study Start Date : February 10, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Iohexol

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 Name: Omnipaque ®




Primary Outcome Measures :
  1. Frequency of patients with a clearance of iohexol < 60 ml/min/1m273 at the end of ICU hospitalisation. [ Time Frame: 24 hours ]
    Iohexol clearance pharmacokinetics


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Correlation between serum creatinine derived measurements of Glomerular Filtratio Rate and iohexol clearance. [ Time Frame: 24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02961478


Contacts
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Contact: François BELONCLE, CCU-AH 0241353845 Francois.Beloncle@chu-angers.fr
Contact: Nicolas LEROLLE, MD PhD 0241353845 NiLerolle@chu-angers.fr

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

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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT02961478     History of Changes
Other Study ID Numbers: PHRC2015-06
First Posted: November 11, 2016    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Renal Insufficiency
Acute Kidney Injury
Kidney Diseases
Urologic Diseases