A feasibility study comparing an approach of individualized blood pressure targets to standard care among critically ill patients with shock
A multicenter before-and-after feasibility study comparing an approach of individualized blood pressure targets to standard care among critically ill patients with shock
Intensive Care Unit, John Hunter Hospital
60 participants
Jan 30, 2018
Interventional
Conditions
Summary
Aims: The aim of the proposed study is to determine feasibility and efficacy of a strategy where BP targets during management of shock in ICU are individualized for each patient based on his/her basal-BP. Primary objective: To demonstrate that compared to the standard care of patients with shock in ICU, a strategy of targeting patients’ basal-BP would minimize the degree of untreated relative hypotension (BP-deficit) during vasopressor therapy by at least 75%. Secondary objectives: To determine whether in this study design, the interventional phase, as compared to conventional care, can (a) enrol at least one patient per week (b) complete follow up for all patients with >90% of data collection (c) reduce the incidence of significant AKI (at least two AKI-stage increase) during the first 14 study days, (d) reduce the peak increase in serum creatinine during the first 7 days among patients not on renal replacement therapy (RRT), (e) reduce percentage of time-points spent with >20% BP-deficit by at least 75%, and (f) be implemented without any appreciable increase in new-onset arrhythmias or serious adverse events. Methods: This is a prospective before-and-after pilot study at multidisciplinary academic ICUs. The study will be conducted over eight consecutive months- first four months of conventional care, followed by the last four months of individualized BP targets. All consecutive eligible patients screened during the two periods will be enrolled in the study. Besides demographics, severity score and clinical outcomes, the study will collect four hourly data on the difference between basal-BP and achieved-BP during the first five days of vasopressor therapy.
Eligibility
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Interventions
The intervention that will be tested is that of individualizing the blood pressure (BP) target for vasopressor therapy during management of shock in ICU over a period of 4 months. In the individualized BP target arm, patient’s own pre-morbid basal mean perfusion BP (MPP) will be considered as an initial target for the vasopressor support. The pre-morbid basal MPP will be derived as the difference between pre-morbid basal mean arterial BP (MAP) estimated from most recent pre-illness BP readings following a standardized method (Panwar et al,. Blood Press. 2017:1-9) and the pre-morbid central venous BP (CVP) estimated from the most recent pre-illness echocardiogram or assumed based on epidemiological data as in previous studies. Clinicians’ discretion to tailor these BP targets as guided by current clinical state will be allowed. Study posters and information material about the intervention will be presented to all clinicians who are working in participating ICUs. Study intervention will cease when the patient either stops receiving ventilatory support in ICU or is considered well enough by the treating clinician for invasive hemodynamic monitoring (arterial line or central line) to cease. If a patient is transported out of ICU for procedural intervention, then standard (non-study) treatment should be provided. 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 is suffering adverse effects (such as myocardial ischemia with concomitant rise in troponin, mesenteric ischemia, new onset arrhythmias and distal limb ischemia) from high vasopressor dose, then the BP targets may be adjusted as deemed fit by the treating clinician and the reasons would be duly recorded. Intervention adherence will be assessed by principal investigators at each participating site. Regular education will be imparted explaining the rationale for the study to encourage strict protocol adherence.
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ACTRN12617001459314