Pilot randomised controlled trial of continuous beta-lactam infusion compared with intermittent dosing in critically ill patients

In critically ill patients with severe sepsis how does continuous beta-lactam infusion compared with intermittent beta-lactam dosing effect pharmacodynamics and clinical response to treatment? A pilot randomised controlled trial.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000238077

Acronym

BLING pilot RCT

Enrollment

Registered

2010-03-22

Start date

2010-04-14

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this pilot randomised controlled trial is to establish the fundamental elements (feasibility, adequacy of blinding, pharmacodynamic effect and separation of endpoints) required to proceed with a large multi-centre randomised controlled trial of beta-lactam antibiotics delivered by continuous infusion compared to standard bolus dosing in critically ill patients. We hypothesise that continuous infusion will more consistently achieve pharmacodynamic endpoints than standard bolus dosing, resulting in improved clinical outcomes.

Interventions

Continuous infusion over 24 hours of one of the following beta-lactam antibiotics: ticarcillin/clavulanate, piperacillin/tazobactam or meropenem; antibiotic choice, dose and duration of treatment are clinician chosen

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1) Confirmed or suspected infection with new organ dysfunction 2) Commencement within the previous 24 hours or planned commencement of ticarcillin/clavulanate, piperacillin/tazobactam or meropenem 3) Expected or actual ICU stay greater than 48 hours

Exclusion criteria

1) Allergy or potential allergy to study medications 2) Receiving palliative or supportive treatment only at the time of screening 3) Receiving contrinuous renal replacement therapy 4) No central venous catheter access with 3 or more lumens 5) Receipt of the study drug of interest for > 24 hours prior to enrolment 6) Discharge from the ICU within 48 hours

Outcome results