Skip to content

Clairance de la morPHinE et filtration glomérulaire chez le Drepanocytaire en crise en REAnimation_PHEDREA

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511985-34-00
Acronym
DR230314
Enrollment
100
Registered
2025-07-15
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Evaluation of the CKD-Epi score to identify a glomerular filtration threshold predictive of morphine failure at usual dosage, using a reference method for assessing renal function: iohexol clearance. All other aspects of the protocol are part of standard care practice.

Brief summary

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).

Detailed description

Clearance of morphine and its metabolites M3G and M6G, Total morphine dose administered over 24 hours and 7 days, Evolution of pain by EVN and EVA (delta over 24h) and PGIC scale at 24h follow-up, Patient-controlled analgesia (PCA) regimen and other coadministered analgesics, Morphine side effects, including impaired alertness, bradypnea, hypercapnia, pruritus, constipation, bloating, nausea, vomiting, acute urinary retention, Correlation between GFR estimated by CKD Epi in basal st

Interventions

DRUGIohexol 300 mg I/ml solution for injection
DRUGMORPHINE (CHLORHYDRATE) RENAUDIN 1 mg/ml
DRUGsolution injectable

Sponsors

Centre Hospitalier Regional Universitaire De Tours
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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).

Secondary

MeasureTime frame
Clearance of morphine and its metabolites M3G and M6G, Total morphine dose administered over 24 hours and 7 days, Evolution of pain by EVN and EVA (delta over 24h) and PGIC scale at 24h follow-up, Patient-controlled analgesia (PCA) regimen and other coadministered analgesics, Morphine side effects, including impaired alertness, bradypnea, hypercapnia, pruritus, constipation, bloating, nausea, vomiting, acute urinary retention, Correlation between GFR estimated by CKD Epi in basal st

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026