Morphine removal and kidney filtering in adults with sickle cell crises in intensive care
Morphine Clearance and Glomerular Filtration in Sickle Cell Patients in Crisis in Intensive Care
This project will test how quickly morphine is cleared from the body in adults with sickle cell disease admitted to intensive care for vaso-occlusive crisis or acute chest syndrome, and whether faster kidney filtering leads to lower morphine levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Tours Academic / other |
| Locations | 6 sites (Tours, France and 5 other locations) |
| Trial ID | NCT07246265 on ClinicalTrials.gov |
What this trial studies
Adults with sickle cell disease admitted to ICU for vaso-occlusive crisis or acute chest syndrome who are receiving patient-controlled morphine will have their kidney filtration measured with an injected iohexol marker and blood sampling for morphine and metabolites. The study compares measured glomerular filtration rate (GFR) to morphine pharmacokinetics to see if renal hyperfiltration accelerates morphine elimination. Patients already on baseline opioid substitution or with contraindications to iohexol are excluded. Findings aim to clarify whether standard morphine dosing under-treats pain in patients with increased GFR.
Who should consider this trial
Good fit: Adults (≥18) with homozygous or compound heterozygous sickle cell disease admitted to ICU for vaso-occlusive crisis or acute chest syndrome who are receiving PCA morphine and can provide consent (or have a relative consent if incapacitated).
Not a fit: Patients on prior opioid substitution therapy (e.g., methadone or buprenorphine), those with contraindications to iohexol, or patients not treated at the participating ICUs are unlikely to benefit from the study findings.
Why it matters
Potential benefit: If successful, the results could help clinicians adjust morphine dosing for sickle cell patients with high kidney filtration so pain is better controlled without unnecessary delays.
How similar studies have performed: Previous pharmacokinetic work suggests altered drug elimination in sickle cell disease, but direct correlation of iohexol-measured GFR with morphine clearance in ICU patients is largely novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient ≥ 18 years old * Known homozygous sickle cell disease SS, SC, S-beta+, or S-beta0 * Admitted in an intensive care unit * Clinical diagnosis of vaso-occlusive crisis and/or acute chest syndrome * Receiving PCA treatment with morphine * Patient's consent for study participation and/or from a relative if case of patient's incapacity * Affiliation to social protection Exclusion Criteria: * Patient previously included in the study during a previous stay * Injection of iodinated contrast medium outside the scope of the study within 24 hours prior to inclusion, or scheduled within 9 hours following the scheduled time of iohexol injection * Contraindication to iohexol: known or suspected immediate or delayed hypersensitivity, thyrotoxicosis. * Patient undergoing morphine treatment or substitution treatment such as methadone or buprenorphine prior to hospitalization (having received morphine or a derivative regardless of the route of administration in the week prior to hospitalization). * Chronic liver disease likely to interfere with morphine metabolism (cirrhosis ) * Any condition that contraindicates the use of morphine according to the summary of product characteristics * Patients under legal protection * Pregnant or breastfeeding women Exclusion criteria : * Need for extrarenal epuration within 24 hours of inclusion
Where this trial is running
Tours, France and 5 other locations
- CHRU de Tours — Tours, France, France (Recruiting)
- Henri-Mondor — Créteil, France (Not_yet_recruiting)
- CH Le Mans — Le Mans, France (Not_yet_recruiting)
- CHU de Nantes — Nantes, France (Not_yet_recruiting)
- CHU d'Orléans — Orléans, France (Not_yet_recruiting)
- CHU de Rennes — Rennes, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Charlotte SALMON-GANDONNIERE, MD
- Email: charlotte.salmon.gandonniere@gmail.com
- Phone: +33 2 47 47 38 55
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.