RecruitingNCT03897582

Beta-Lactams Dosing In Pneumonia in ICU in Patients Treated by Continuous Renal Replacement Therapy: the BLIPIC Study

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


Sponsor

Centre Hospitalier de Valenciennes

Enrollment

65 participants

Start Date

Feb 22, 2019

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria21

  • 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

Exclusion Criteria10

  • Aged < 18 years
  • ECMO
  • Cystic fibrosis
  • Burn victim
  • Pregnant woman
  • Any rapidly-progressing disease or immediately life-threatening illness
  • Objection from the patients or their legally authorised representative
  • No social security scheme
  • Interruption of antibiotic before samples
  • Patient in prison

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Locations(1)

Centre Hospitalier de Valenciennes

Valenciennes, Nord, France

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NCT03897582


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