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Набира участници Не е приложимо NCT05850962

Individualised Blood Pressure Targets Versus Standard Care Among Critically Ill Patients With Shock

Не е приложима фаза (напр. обсервационно)
Заболявания: Critical Illness Shock

Спонсор: Rakshit Panwar

Налично на: БГ
Обобщение
Aim The aim of the proposed RCT is to determine effectiveness of a strategy, where MAP (mean arterial blood pressure) targets during vasopressor therapy for shock in ICU are individualized based on patients' own pre-illness MAP that would be derived as an average of up to five most recent pre-illness blood pressure readings. Hypothesis We hypothesize that targeting a patient's pre-illness MAP during management of shock can minimize the degree of MAP-deficit (a measure of relative hypotension), which may help reduce the risk of 14-day mortality and major adverse kidney events by day 14 in ICU. Endpoints The primary endpoint will be the all-cause mortality rate at day 14. Secondary endpoints will be the time to death through day 14 and day 90, major adverse kidney events (MAKE-14), renal replacement therapy (RRT) free days until day 28, and 90-day all-cause mortality. Significance To date no major RCT has tested this strategy among ICU patients with shock. This pivotal trial will provide evidence to fulfil a crucial knowledge gap regarding a common and a fundamental intervention in critical care.
Кой може да участва
Inclusion Criteria: * ICU patients aged greater than or equal to 40 years * The patient is deemed to be in shock, defined as clinician-initiated vasopressor/inotropic therapy AND supported by any of the following within the last 24 hours: * Lactate level greater than or equal to 2 mmol/l or base deficit greater than or equal to 3 mmol/l, * Urine output less than or equal to 0.5 ml/kg/h or \<40 ml/h for 2 or more consecutive hours * Respiratory rate \>22 per minute * Altered mentation (Glasgow Coma Score \<14) Exclusion Criteria: * 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. * Previously enrolled in the REACT Shock RCT * Pregnancy, if known * Active bleeding (clinical suspicion or \>2 packed red blood cells within last 24 hours) * Insufficient (less than two) pre-illness BP readings are available. * Patients on extracorporeal support (such as extracorporeal membrane oxygenation, intra-aortic balloon pump, or ventricular assist device). * Potential contraindications to either higher or lower BP targets (including but not limited to) * Cerebral perfusion pressure guided therapy e.g. intracranial hemorrhage or subarachnoid hemorrhage or traumatic brain injury * Abdominal perfusion pressure guided therapy * Aortic injury (e.g. dissection or post-operative) * Post cardiac surgery * Any other condition requiring higher or lower BP target specifically
Места на провеждане 1
Австралия (1)
Hunter Medical Research Institute
Newcastle , New South Wales
Технически детайли
Статус
Набира участници
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
40 Years
Здрави доброволци
Не
Начална дата
20.07.2023
Крайна дата
30.10.2028
Регистрационен номер
NCT05850962
Източник
anzctr
Запитване за медицински туризъм

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