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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04776486
Other study ID # APHP190414
Secondary ID 2019-A00654-53
Status Recruiting
Phase N/A
First received
Last updated
Start date September 3, 2020
Est. completion date March 2024

Study information

Verified date January 2024
Source Assistance Publique - Hôpitaux de Paris
Contact Magalie Collet, MD
Phone +33 (0)149958515
Email magalie.collet@aphp.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Evaluation of glomerular filtration rate using iohexol plasma clearance in critically ill patients with augmented renal creatinine clearance


Description:

Single center study in ICU patients with augmented renal clearance comparing glomerular filtration rate (GFR) as measured by iohexol plasma clearance to that measured by creatinine clearance. Primary objective is to compare the GFR estimates made by iohexol plasma clearance (as reference method) and creatinine clearance using Bland-Altman method. Secondary objective are to compare GFR as measured by iohexol plasma clearance to that calculated with the most commonly used renal clearance estimating formulas (Cockcroft and Gault, MDRD and CKD-EPI ), evaluate clinical determinant of the observed differences and evaluate determinants of extracellular volume.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date March 2024
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - ICU patient - 24h Creatinine clearance >130ml/min/1.73m2 - Urinary catheterization - Affiliation to a social security scheme Exclusion Criteria: - Pregnancy - CT-scan with contrast media infusion the day of inclusion - Documented allergy to contrast media - Patient under guardianship / curatorship - Patient benefiting from the "State Medical Assistance"

Study Design


Intervention

Drug:
Iohexol
Intravenous injection of 5 ml of iohexol (Omnipaque) to calculate the glomerular filtration rate (area under the curve). Blood samples (2 ml) and urine (2 ml minimum) are to be collected for the determination of iohexol clearance at the following time points: pre-dose, 5 minutes, and 1, 2, 3, 4, 5, 6 hours post dose.

Locations

Country Name City State
France Lariboisière Hospital, Surgical ICU Paris Ile De France

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

Salmon-Gandonniere C, Benz-de Bretagne I, Mercier E, Joret A, Halimi JM, Ehrmann S, Barin-Le Guellec C. Iohexol clearance in unstable critically ill patients: a tool to assess glomerular filtration rate. Clin Chem Lab Med. 2016 Nov 1;54(11):1777-1786. doi: 10.1515/cclm-2015-1202. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary GFR obtained by the iohexol clearance technique GFR as measured by iohexol plasma clearance to evaluate its concordance, by the Bland and Altman method, with that obtained by measuring the clearance of creatinine. 6 hours
Primary GFR obtained by the creatinine clearance technique GFR as measured by creatinine plasma clearance 6 hours
Secondary GFR calculated using the Cockroft-Gault equation Estimation of GFR using the Cockroft-Gault method based on the serum creatinine clearance measured on the day of intervention and the patient's weight of the day, and the agreement with the GFR measured by the iohexol clearance 6 hours
Secondary GFR calculated using the Modification of diet in renal disease (MDRD) formula Estimation of GFR using MDRD method based on the serum creatinine clearance measured on the day of intervention and the patient's weight of the day, and the agreement with the GFR measured by the iohexol clearance 6 hours
Secondary GFR calculated using the Chronic Kidney Disease - Epidemiology Collaboration (CKD-EPI) equation Estimation of GFR using CKD-EPI method based on the serum creatinine clearance measured on the day of intervention and the patient's weight of the day, and the agreement with the GFR measured by the iohexol clearance 6 hours
Secondary Plasmatic Levetiracetam dosing To detect underdosing and risk of therapeutic failure of Levetiracetam 6 hours
Secondary Plasmatic Vancomycin dosing To detect underdosing and risk of therapeutic failure of Vancomycin 6 hours
Secondary Plasmatic Piperacillin dosing To detect underdosing and risk of therapeutic failure of Piperacillin 6 hours
Secondary Plasmatic Cefotaxim dosing To detect underdosing and risk of therapeutic failure of Cefotaxim 6 hours
Secondary Plasmatic Aminoglycoside dosing To detect underdosing and risk of therapeutic failure of Aminoglycoside 6 hours
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