Informations générales (source: ClinicalTrials.gov)

NCT02961478 Statut inconnu
Measurement of Iohexol Plasma Clearance in Patients Leaving ICU After Acute Renal Failure (IOXSOR)
Interventional
  • Insuffisance rénale
  • Atteinte rénale aigüe
Phase 3
University Hospital, Angers (Voir sur ClinicalTrials)
février 2017
décembre 2020
29 juin 2024
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.

Etablissements

Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Hospital center - Chartres - France Alexandre CONIA, MD En recrutement Contact (sur clinicalTrials)
University Hospital - Angers - France François BELONCLE, CCU-AH En recrutement Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Hospital - Le Mans - France Patrice TIROT, MD Recrutement non commencé Contact (sur clinicalTrials)
University Hospital - Poitiers - France René Robert, MD PhD En recrutement Contact (sur clinicalTrials)
University Hospital - Tours - France Stephan EHRMANN, MD PhD En recrutement Contact (sur clinicalTrials)

Critères

Tous
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.



- 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