Prescription Strategies of Amikacin in Intensive Care Patients on Renal Replacement Therapy: an Observational Prospective Multicenter Study

NCT04322019 | Completed

• 1 other identifier: PO20032
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Amikacin Treatment

Keywords

Amikacin; intensive care; renal replacement therapy; prescription strategy,; monitoring strategy

Outcome Measures

Primary Outcomes (1)

• Measurement of maximum concentration observed

  Monitoring of Amikacin treatment using measurement of maximum concentration observed performed or not

  Day 0

Study Arms (1)

"Amikacin treatment" group

Intensive care patients on renal replacement therapy with Amikacin treatment

Other: Data record

Interventions

Data record OTHER

Data record

"Amikacin treatment" group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Intensive care patients on renal replacement therapy with Amikacin treatment

You may qualify if:

• patients in intensive care
• patients on extrarenal replacement
• patients with Amikacin treatment
• patients accepting to participate in the study

You may not qualify if:

• patients less than 18 years old
• pregnant women
• patients with Amikacin treatment in the previous 7 days

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Damien JOLLY

Reims, France

Location

MeSH Terms

Interventions

Electronic Health Records

Intervention Hierarchy (Ancestors)

Medical Records Systems, Computerized; Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: March 26, 2020
• Study Start: May 25, 2020
• Primary Completion: February 16, 2022
• Study Completion: May 16, 2022
• Last Updated: June 16, 2022

Record last verified: 2022-06

Locations

FR (1)