A pilot multicenter randomized study comparing an approach of individualized blood pressure targets to standard care among critically ill patients with shock
A pilot multicenter randomized controlled trial comparing an approach of individualized blood pressure targets to standard care among critically ill patients with shock
Intensive Care Unit, John Hunter Hospital
50 participants
Dec 20, 2018
Interventional
Conditions
Summary
Aims: The aim of the proposed pilot RCT is to determine feasibility and efficacy of a strategy where MAP targets during management of shock in ICU are individualized for each patient based on his/her pre-illness MAP. Primary objective: To determine if, compared to standard care, among patients with shock in ICU, a strategy of targeting patients’ pre-illness MAP would substantially reduce the degree of BP-deficit during vasopressor therapy and result in lower rise in peak creatinine within the first 5 days of randomization. Secondary objectives: To compare the percentage time spent with at least 20% BP-deficit, and to compare area-under-curve for the change in serum cystatin C during the first 3 days of randomization in both arms. Other outcomes would be day 14 mortality, incidence of MAKE 14, time to death through day 14, renal replacement therapy (RRT) free days until day 28, and time to death through day 90. Methods: This is a prospective pilot multicenter RCT at academic ICUs. The study will randomly assign 50 patients to either standard care or to an individualized MAP target strategy. Besides demographics, severity score and clinical outcomes, the study will collect four hourly data on MAP-deficit i.e., the difference between pre-illness MAP and achieved-MAP, during the first five days of vasopressor therapy.
Eligibility
Inclusion Criteria6
- 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:
- o Lactate level greater than or equal to 2 mmol/l or base deficit greater than or equal to 3 mmol/l,
- o Urine output less than or equal to 0.5 ml/kg/h or <40 ml/h for 2 or more consecutive hours
- o Respiratory rate >22 per minute
- o Altered mentation (Glasgow Coma Score <14)
Exclusion Criteria16
- 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)
- o Cerebral perfusion pressure guided therapy e.g. intracranial hemorrhage or subarachnoid hemorrhage or traumatic brain injury
- o Abdominal perfusion pressure guided therapy
- o Aortic injury (e.g. dissection or post-operative)
- o Post cardiac surgery
- o Any other condition requiring higher or lower BP target specifically
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Interventions
The project will test an intervention that initially targets a patient's own pre-illness mean arterial pressure (MAP) during vasopressor support in ICU. The pre-illness MAP will be estimated from most recent pre-illness BP readings following a standardized method (Panwar et al,. Blood Press. 2017:1-9) and will be targeted for the duration of vasopressor therapy for up to a maximum of five days. The treating clinician can tailor these BP targets as deemed suitable for current clinical state. The range for MAP target is 55-95 mmHg. During the period of study treatment, a range of ±2 mmHg around the set target is acceptable. If the total additional vasopressor dose required to achieve these individualized MAP targets exceeds 0.75 microgram/kg/minute, or if in the opinion of the treating clinician the patient may be suffering possible adverse effects from high vasopressor dose, then the BP targets may be adjusted as deemed fit by the treating clinician. Protocol adherence for participants will be monitored during the screening rounds. Protocol deviation will be defined as failure to adjust dose of vasopressor agents while the MAP remained at least 6 mmHg above or below the set target for 4 consecutive hours, without a documented change of MAP target by the treating clinician. Study intervention will cease if a patient is considered well enough by the treating clinician for discharge out of ICU. If a patient is transported out of ICU for procedural intervention, then standard (non-study) treatment should be provided.
Locations(5)
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ACTRN12618000571279