Beta-Lactams Dosing In Pneumonia in ICU in Patients Treated by Continuous Renal Replacement Therapy

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Pneumonia are the most frequent infections in ICU. Little is known about beta-lactam doses necessary for this infection for patients treated with continuous veino-veinous hemodialysis. The pharmacokinetic variability expose to over and underdosage leading to toxicity or therapeutic failure. The aim of this study is to define if beta-lactams doses used in pneumonia for patients with acute kidney injury treated with our hemodialysis conditions lead to beta-lactam therapeutic plasma levels.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Aged ≥ 18 years

• Receiving intraveinous beta-lactam : amoxicillin, amoxicillin-clavulanic acid, piperacillin-tazobactam, cefotaxime, ceftazidime, cefepime, meropenem, imipenem

• With AKI defined as any of the following, and treated with Multifiltrate Ci-Ca CVVHD 1000® kit with a dialysis dose of 25 ml/kg/h :

‣ Increase in creatininemia ≥ 0.3 mg/dl (≥ 26.5 µmol/l) within 48 hours

⁃ Increase in creatininemia ≥ 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days

⁃ Urine volume \< 0.5 ml/kg/h for 6 hours

• Hospitalized in ICU

• Presence of a catheter to facilitate sample collection

• With pneumonia defined as any of the following :

‣ Chest X-ray pneumonia : opacities, new or progressive infiltrates

⁃ AND at least one of the following : hyperthermia \> 38°C or hypothermia \< 36°C with no other explanation ; leukopenia \< 4 G/L ou leukocytosis \> 12G/L

⁃ AND at least one of the following : new onset purulent sputum or change in sputum character, new onset or worsening cough or dyspnea or tachypnea, rales or bronchial breathing, lower oxygen saturation/hypoxemia or increase of oxygen needs or respiratory assistance

• Treated within 24 hours by citrate hemodialysis AND beta-lactam respecting dose and administration conditions of the study :

‣ Amoxicillin : loading dose followed immediately by 2g by extended infusion for 4 hours every 8 hours

⁃ Amoxicillin-clavulanic acid : 2g every 8 hours by intermittent bolus

⁃ Piperacillin-tazobactam: loading dose followed immediately by 4g/0.5g by continuous infusion every 8 hours (\< 80 kg) ou 6 hours (\> 80 kg)

⁃ Cefotaxime: loading dose followed immediately by 2g by continuous infusion every 8 hours Ceftazidime : loading dose followed immediately by 2g by continuous infusion every 8 hours

⁃ Cefepime: loading dose followed immediately by 2g by continuous infusion every 8 hours

⁃ Meropenem : loading dose followed immediately by 2g (\> 60 kg) ou 1,33g (\< 60 kg) by extended infusion for 4 hours every 8 hours

⁃ Imipenem : loading dose followed immediately by 750 mg (\< 80 kg) ou 1g (\> 80 kg) by extended infusion for 4 hours every 6 hours In case of extrem weight, dose will be on investigator's discretion but administration conditions have be to respected.

• No objection has been obtained from the patient or their legally authorised representative

Locations
Other Locations
France
Centre Hospitalier de Valenciennes
RECRUITING
Valenciennes
Contact Information
Primary
Fabien Lambiotte, MD
lambiotte-f@ch-valenciennes.fr
+ 33 3 27 14 33 33
Backup
Justine Lemtiri, Pharm D
lemtiri-j@ch-valenciennes.fr
+ 33 3 27 14 33 33
Time Frame
Start Date: 2019-02-22
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 65
Authors
Chloé Rousselin
Related Therapeutic Areas
Sponsors
Collaborators: Centre hospitalier de Boulogne, Centre Hospitalier de Bethune, Centre Hospitalier de Lens, University Hospital, Lille, General Hospital of Douai
Leads: Centre Hospitalier de Valenciennes

This content was sourced from clinicaltrials.gov

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