Amikacin Treatment Clinical Trial
— AMIDIAL-ICUOfficial title:
Prescription Strategies of Amikacin in Intensive Care Patients on Renal Replacement Therapy: an Observational Prospective Multicenter Study
| NCT number | NCT04322019 |
| Other study ID # | PO20032 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 25, 2020 |
| Est. completion date | May 16, 2022 |
| Verified date | June 2022 |
| Source | CHU de Reims |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Amikacin is the aminoglycoside of choice for treatment of severe infections in intensive care. An achievement of its objectives in pharmacokinetics and pharmacodynamics is difficult in intensive care patients because of modification of their volume of distribution and renal clearance. Acute renal failure requiring renal replacement therapy is frequent in intensive care. Extrarenal purification modalities (continuous versus intermittent, type of dialysis membrane), which can influence amikacin clearance, are multiple and teams dependent. Guidelines of good practice for Amikacin in intensive care patients do not exist.
| Status | Completed |
| Enrollment | 112 |
| Est. completion date | May 16, 2022 |
| Est. primary completion date | February 16, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | inclusion criteria : - patients in intensive care - patients on extrarenal replacement - patients with Amikacin treatment - patients accepting to participate in the study exclusion criteria : - patients less than 18 years old - pregnant women - patients with Amikacin treatment in the previous 7 days |
| Country | Name | City | State |
|---|---|---|---|
| France | Damien JOLLY | Reims |
| Lead Sponsor | Collaborator |
|---|---|
| CHU de Reims |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Measurement of maximum concentration observed | Monitoring of Amikacin treatment using measurement of maximum concentration observed performed or not | Day 0 |