A phase IIb randomised controlled trial of continuous beta-lactam infusion compared with intermittent beta-lactam dosing in critically ill patients BLING II

Phase 2

Completed

• Conditions: Severe Sepsis in the Intensive Care patient; Infection - Studies of infection and infectious agents; Blood - Other blood disorders

• Registration Number: ACTRN12612000138886
• Lead Sponsor: HMRC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 442

Inclusion Criteria

1.Confirmed or suspected infection with new organ dysfunction, based on established entry criteria for severe sepsis
2.The treating clinician has chosen ticarcillin-clavulanate, meropenem or piperacillin-tazobactam to treat the episode of infection in Criterion 1.
3.The treating clinician is uncertain if administration of the chosen antibiotic by bolus administration or by infusion is superior.
4.At the time of the assessment of suitability for the study, the treating ICU specialist expects the patient will require treatment in the ICU that extends beyond the next calendar day.

Organ Dysfunction Entry Criteria:
The patient must meet one or more the following organ dysfunction entry criteria in the previous 24 hours:
1.Cardiovascular (shock):
An arterial systolic blood pressure (SBP) of equal to 90 mmHg or a mean arterial pressure (MAP) equal to 70 mmHg for at least one hour despite adequate fluid resuscitation or adequate intravascular volume status (as previously defined), and/or need for vasopressors to achieve a SBP or MAP target (as specified by the treating physician) for greater than one hour. Vasopressors are defined as:
a)Dopamine greater than 5 micro g/kg/min
b)Noradrenaline, adrenaline, metaraminol or phenylephrine by infusion at any dose.
2.Renal:
Acute kidney injury with serum creatinine greater than 1.5 x hospital admission creatinine or less than 0.5 ml/kg/hour for 6 hours. A patient with loss of kidney function or end-stage kidney disease (defined as the need for renal replacement therapy for more than 4 weeks or the need for dialysis for longer than 3 months) would need to meet one of the other organ failure criteria.
3.Respiratory:
Respiratory failure defined as PaO2/FiO2 equal to 200.
4.Haematology:
Platelet count of less than 80 x 109/L or a greater than 50% decrease in the platelet count from the highest recorded value within the preceding 3 days.
5.Metabolic acidosis:
Defined by one of the following:
a)pH less than 7.30
b)Base deficit greater than 5.0 mmol/L
c)A venous or arterial plasma lactate level greater than 1.5 times the upper limit of normal for the reporting laboratory.

Exclusion Criteria

Patients meeting one or more of the following criteria are to be excluded:
1.Receipt of any potential study drug for more than 24 hours prior to randomisation during this admission to the ICU
2.Age less than 18 years
3.Allergy or potential allergy to the study medications
4.Pregnancy
5.No central venous catheter access with three or more lumens
6.Receiving palliative or supportive treatment only at the time of assessment for eligibility
7.Treating physician is not committed to provision of advanced life-support including any of mechanical ventilation, dialysis, and vasopressor administration for at least the next 48 hours
8.Death is deemed imminent and inevitable
9.The patient has an underlying process that is likely to result in death before 90 days of follow up.
10. Consent has not been gained for study participation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified