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

NCT03897582 | Recruiting

• 1 other identifier: 2018-05
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Beta-lactam; Continuous Renal Replacement Therapy; Pneumonia; Antibiotic

Keywords

amoxicillin; amoxicillin-clavulanic acid; piperacillin-tazobactam; cefotaxime; ceftazidime; cefepime; meropenem; imipenem; multifiltrate; citrate; CVVHD; extended and continuous infusion; TDM; Therapeutic Drug Monitoring

Outcome Measures

Primary Outcomes (1)

• Percentage of beta-lactams concentrations above plasma therapeutic levels

  We aimed to obtain concentrations over 5 MIC (Minimum inhibitory concentration) for at least 80% of patients.

  Day 3 after start of antibiotic and continuous veino-veinous hemodialysis

Secondary Outcomes (4)

• Distribution of steady state beta-lactam concentrations and their variability

  Day 3 after start of antibiotic and continuous veino-veinous hemodialysis

• Incidence of neurotoxicity

  Day 7 after start of antibiotic and continuous veino-veinous hemodialysis

• Trends in beta-lactam concentrations between 2 days

  At Day 1 and Day 2

• Clinical response observed when beta-lactam concentrations achieved 5 MIC

  At Day 28 and day 90

Eligibility Criteria

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

Study Population

Adults with pneumonia in ICU treated with intraveinous beta-lactams and CVVHD

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier de Valenciennes: lead
• Centre Hospitalier de Lens: collaborator
• Centre Hospitalier de Bethune: collaborator
• University Hospital, Lille: collaborator
• General Hospital of Douai: collaborator
• Centre hospitalier de Boulogne: collaborator

Study Sites (1)

Centre Hospitalier de Valenciennes

Valenciennes, Nord, 59300, France

RECRUITING

Related Links

• SFAR, SFPT, Recommandations de Pratiques Professionnelles, Optimisation du traitement par bêta-lactamines chez le patient de soins critiques 2018.

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Fabien Lambiotte, MD

  Centre Hospitalier de Valenciennes

  STUDY CHAIR

Central Study Contacts

Fabien Lambiotte, MD

CONTACT

+ 33 3 27 14 33 33; lambiotte-f@ch-valenciennes.fr

Justine Lemtiri, Pharm D

CONTACT

+ 33 3 27 14 33 33; lemtiri-j@ch-valenciennes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2019
• First Posted: April 1, 2019
• Study Start: February 22, 2019
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: February 2, 2024

Record last verified: 2024-02

Locations

FR (1)