IOHEXOL for Sickle cell anaemia | Vaso-occlusive crisis | Acute chest syndrome

Inclusion criteria

• {"criterion_text":"- Patient ≥ 18 years\n- Known homozygous sickle cell disease SS, SC, S-beta+ or S-beta0\n- Admitted to a Continuous Care Unit (CCU) or intensive care unit.\n- Clinical diagnosis of vaso-occlusive crisis and/or acute chest syndrome\n- Receiving morphine PCA therapy\n- Obtained consent to participate in the study and/or from a parent/relative in the event of patient incapacity\n- Affiliation with a social securitý scheme."}

Exclusion criteria

• {"criterion_text":"- Patient included in the study during a previous stay\n- Injection of iodinated contrast medium outside the study in the 24 hours prior to inclusion, or scheduled within 9 hours of the scheduled time of iohexol injection.\n- Contraindication to iohexol: known or suspected immediate or delayed hypersensitivitý, thyrotoxicosis\n- Patient on morphine therapy or methadone- or buprenorphine-type substitution therapy, prior to hospitalization (having received morphine or derivative by any route in the week preceding hospitalization)\n- Chronic liver disease likely to interfere with morphine metabolism (cirrhosis stage)\n- Patient under legal protection\n- Pregnant or breast-feeding woman\n- Any condition constituting a contraindication to the use of morphine according to the summary of product characteristics"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint was the area under the ROC curve for prediction of therapeutic failure by GFR according to CKD Epi. Therapeutic failure is defined by a percentage of relief assessed by EVN (numerical verbal scale) not reaching 30% in 24h (Darbari, 2017).","definition_or_measurement_approach":"Prediction performance measured as area under the ROC curve; therapeutic failure defined as percentage of relief on EVN not reaching 30% within 24 hours."}

Secondary endpoints

• {"endpoint_text":"- Clearance of morphine and its metabolites M3G and M6G","definition_or_measurement_approach":"Measured via plasma samples (4 samples T1-T4) and iohexol-synchronised samples; clearances estimated using pharmacokinetic modelling (Monolix) with compartmental models."}
• {"endpoint_text":"- Total morphine dose administered over 24 hours and 7 days","definition_or_measurement_approach":"Total morphine dose recorded by PCA daily for 7 days; 24-hour and 7-day totals."}
• {"endpoint_text":"- Evolution of pain by EVN and EVA (delta over 24h) and PGIC scale at 24h follow-up","definition_or_measurement_approach":"Pain assessed by EVN and VAS every 4 hours; PGIC every 24 hours; change over 24h evaluated."}
• {"endpoint_text":"- Patient-controlled analgesia (PCA) regimen and other coadministered analgesics","definition_or_measurement_approach":"Record of PCA settings, number of boluses administered/refused, and co-administered analgesics and doses."}
• {"endpoint_text":"- Morphine side effects, including impaired alertness, bradypnea, hypercapnia, pruritus, constipation, bloating, nausea, vomiting, acute urinary retention","definition_or_measurement_approach":"Daily monitoring and recording of listed adverse events during follow-up period."}
• {"endpoint_text":"- Correlation between GFR estimated by CKD Epi in basal st","definition_or_measurement_approach":"Correlation analysis between estimated GFR values (CKD-Epi) at baseline and other states (methodological endpoint)."}

Methods

• Patient screening carried out by clinical research nurses in the centres under the responsibility of the investigators; investigators present the study to eligible patients and obtain consent. Inclusion performed as early as possible, within 24 hours of patient admission (in-hospital recruitment at participating CCU/ICU sites in France).

France

Earliest CTIS Part Ii Submission Date

10-06-2025

Latest Decision Or Authorization Date

08-10-2025

Processing Time Days

120

Number Of Sites

6

Number Of Participants

100

Primary sponsor

Full Name

Centre Hospitalier Regional Universitaire De Tours

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France