External Validation of the Beta-lactam Target Non-attainment (BATMAN) Risk Score in Adult ICU Patients: a Diagnostic Multivariate Predictive Risk Model

NCT ID: NCT05542771

Last Updated: 2023-05-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 130 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-24
• Study Completion Date: 2023-11-01

Brief Summary

Intensive care (IC) patients regularly get infections. Sometimes it is even the reason of admission to the intensive care unit. To treat these infections, we give medicines called antibiotics, such as β-lactams antibiotics. Every IC patient receives the same dose of β-lactams antibiotics, while we know this can lead to undertreatment in some IC patients. The BATMAN risk score was created to predict which IC patient is undertreated. This study aims to validate the BATMAN risk score so it can be used in clinical practice.

Detailed Description

In order to predict which intensive care unit (ICU) patients are not likely to achieve target attainment of beta-lactam antibiotics, a diagnostic multivariable prediction model was developed using random forest analysis. Gender, age, creatinine, and type of beta-lactam antibiotic were included in the final model and translated into a user-friendly and easy-to-implement risk score. As the name suggests, the beta-lactam target non-attainment (BATMAN) risk score predicts which adult ICU patients fail to achieve target attainment and intents efficient use of TDM of beta-lactam antibiotics. In order to use the BATMAN risk score in as many hospitals as possible in clinical practice, an external validation will be performed by a multicenter prospective observational study. All adult ICU patients admitted to the participating hospitals that are treated with beta-lactam antibiotics will be screened for eligibility. One beta-lactam trough plasma concentration, clinical and non-clinical data will be collected prospectively. To our knowledge, no other beta-lactam target non-attainment risk score for adult ICU patients has yet been developed let alone externally validated. This research is essential because ICU patients are a highly heterogenic group of patients that undergo extensive physiological alterations that will have impact on antibiotic pharmacokinetics, such as beta-lactam antibiotics. For the beta-lactams, achievement of an adequate drug level is associated with a higher likelihood of clinical success and a decrease in the potential for antimicrobial resistance. Yet, target attainment remains a challenge with the traditional 'one-dose-fits-all' strategy.

Conditions

Infection, Bacterial; Beta-lactam Antibiotics; Critical Care; Risk Model; Therapeutic Drug Monitoring

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Written informed consent has been obtained from the patient or their legally authorised representative
• Age ≥18 years
• Treated with one of the following beta-lactam antibiotics at the ICU with intermitted dosage

• Amoxicillin (with or without clavulanic acid)
• Cefotaxime
• Ceftazidime
• Cefuroxime
• Flucloxacillin
• Meropenem
• Piperacillin with tazobactam
• Eligible blood material within 36 hours after start of beta-lactam antibiotic to determine target attainment (100%ƒT > MICECOFF).
• Suitable intravenous/intra-arterial access to facilitate sample collection

Exclusion Criteria

• Pregnancy
• Beta-lactam antibiotic cessation before blood sample collection
• Receiving beta-lactam antibiotic only as prophylaxis within the context of Selective Digestive tract Decontamination (SDD)
• Patients with renal replacement therapy
• Patients with burn injury

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chantal Kats

OTHER

Sponsor Role: lead

Responsible Party

Chantal Kats

MSc Chantal Kats, coordinating researcher (Sponsor is Erasmus Medical Center)

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Alan Adulla, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

Isala Hospital

Zwolle, Gelderland, Netherlands

Site Status: NOT_YET_RECRUITING

VieCuri Medical Center

Venlo, Limburg, Netherlands

Site Status: RECRUITING

Erasmus Medical Center

Rotterdam, South Holland, Netherlands

Site Status: RECRUITING

Franciscus Gasthuis & Vlietland

Rotterdam, South Holland, Netherlands

Site Status: NOT_YET_RECRUITING

Haaglanden Medisch Centrum

The Hague, South Holland, Netherlands

Site Status: NOT_YET_RECRUITING

Diakonessenhuis

Utrecht, , Netherlands

Site Status: NOT_YET_RECRUITING

Countries

Netherlands

Central Contacts

Chantal Kats, MSc

Role: CONTACT

c.kats@haaglandenmc.nl

+31634424848

Facility Contacts

Jasper Haringman, MD

Role: primary

Manon Fleuren-Janssen

Role: primary

Alan Abdulla, PhD, MD

Role: primary

Dorien Kiers, MD

Role: primary

Chantal Kats, MSc

Role: primary

Attila Karakus, MD

Role: primary

Other Identifiers

NL181245.078.22

Identifier Type: -

Identifier Source: org_study_id