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

Acute Renal Failure Clinical Trial

— IOXSOR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02961478
• Other study ID #: PHRC2015-06
• Status: Recruiting
• Phase: Phase 3
• Start date: February 10, 2017
• Est. completion date: December 2020

Study information

• Verified date: March 2019
• Source: University Hospital, Angers
• Contact: François BELONCLE, CCU-AH
• Phone: 0241353845
• Email: Francois.Beloncle[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 (?Créatinine) 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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Failure
• Renal Insufficiency

Intervention

Drug:
• IOHEXOL
Estimate iohexol clearance at the end of stay in intensive care for patients who had an episode of acute renal failure.

Locations

Country	Name	City	State
France	University Hospital	Angers
France	Hospital center	Chartres
France	Hospital	Le Mans
France	University Hospital	Poitiers
France	University Hospital	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of patients with a clearance of iohexol < 60 ml/min/1m273 at the end of ICU hospitalisation.	Iohexol clearance pharmacokinetics	24 hours
Secondary	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
Secondary	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
Secondary	Correlation between serum creatinine derived measurements of Glomerular Filtratio Rate and iohexol clearance.		24 hours