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

Phase 3

• Conditions: Acute Renal Failure
• Interventions: Drug: IOHEXOL

• Registration Number: NCT02961478
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-03
• Study First Submitted QC: 2016-11-08
• Study First Posted: 2016-11-11
• Study Start: 2017-02-10
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-15
• Last Update Posted: 2019-03-19
• Primary Completion: 2020-06
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Iohexol plasmatic clearance	IOHEXOL	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

University Hospital; 🇫🇷 Tours, France

Hospital center; 🇫🇷 Chartres, France

Hospital; 🇫🇷 Le Mans, France