Clinical trial NCT02961478: Measurement of Iohexol Plasma Clearance in Patients Leaving ICU After Acute Renal Failure
Official title: Measurement of Iohexol Plasma Clearance in Patients Leaving ICU After Acute Renal Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute Renal Failure
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2016-11-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Frequency of patients with a clearance of iohexol < 60 ml/min/1m273 at the end of ICU hospitalisation.
timeFrame: 24 hours
Secondary outcomes:
measure: 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
timeFrame: Six month after ICU discharge
measure: 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
timeFrame: 24 hours
measure: Correlation between serum creatinine derived measurements of Glomerular Filtratio Rate and iohexol clearance.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital
city: Chartres
country: France
facility: Hospital center
city: Le Mans
country: France
facility: Hospital
city: Poitiers
country: France
facility: University Hospital
city: Tours
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Angers
name: François BELONCLE, CCU-AH
role: PRINCIPAL_INVESTIGATOR
References: