A pilot multicenter randomized study comparing an approach of individualized blood pressure targets to standard care among critically ill patients with shock
- Conditions
- Critically ill patients with shockCardiovascular - Other cardiovascular diseases
- Registration Number
- ACTRN12618000571279
- Lead Sponsor
- Intensive Care Unit, John Hunter Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
•ICU patients aged greater than or equal to 40 years
•The patient is deemed to be in shock, defined as clinician-initiated vasopressor therapy AND supported by any of the following within the last 24 hours:
oLactate level greater than or equal to 2 mmol/l or base deficit greater than or equal to 3 mmol/l,
oUrine output less than or equal to 0.5 ml/kg/h or <40 ml/h for 2 or more consecutive hours
oRespiratory rate >22 per minute
oAltered mentation (Glasgow Coma Score <14)
•Patients who are moribund, or have documented not-for-resuscitation orders
•At least 24 hours have lapsed from the time of initiation of vasopressor or inotropic support
•Patients who are either receiving or are deemed to imminently need renal replacement therapy.
•Patients who already have an increase in serum creatinine of >350 µmol/l from baseline.
•End stage renal disease
•Patients where trauma is the main reason for the current ICU admission.
•Pregnancy, if known
•Active bleeding (clinical suspicion or >2 packed red blood cells within 24 hours)
•Insufficient (less than two) pre-morbid BP readings are available.
•Patients on extracorporeal support (ECMO, IABP, VAD).
•Potential contraindications to either higher or lower BP targets (including but not limited to)
oCerebral perfusion pressure guided therapy e.g. intracranial hemorrhage or subarachnoid hemorrhage or traumatic brain injury
oAbdominal perfusion pressure guided therapy
oAortic injury (e.g. dissection or post-operative)
oPost cardiac surgery
oAny other condition requiring higher or lower BP target specifically
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The degree of relative hypotension, assessed as the mean percentage MAP-deficit, which will be derived as an area-under-curve (AUC) - as an integrated expression of mean percentage MAP-deficit achieved over the active treatment period. MAP-deficit will be the percentage deficit between the pre-illness MAP and the achieved-MAP that will be derived from the MAP recorded in the patient's observation chart during ICU stay.[Measurements will be assessed four hourly, until a patient is weaned off vasopressor support for at least 24 hours or until a maximum of five days, whichever is earlier. ];Peak increase in serum creatinine levels [Performed at least daily during the first 5 days of randomization]
- Secondary Outcome Measures
Name Time Method Area-under-the-curve for change in serum cystatin C[Performed daily during the first 3 days of randomization];Major Adverse Kidney Events (defined as a composite of death, new renal replacement therapy, or final serum creatinine level >= 200% of the latest premorbid creatinine level)[Within 14 days of enrolment];Percentage of time-points with >20% MAP-deficit[Based on 4 hourly timepoints during the first 5 days of randomization];Renal replacement therapy free days until day 28 (assessed using medical record)[Day 28 from enrolment];Time to death through day 14 (assessed using medical records)[First 14 days of randomization];Mortality, as assessed from medical case records[90 days from enrolment];Death[14 days of enrolment];Time to death through day 90 (assessed from medical record))[90 days of enrolment]