About this trial
Shock is a life-threatening condition which can cause multiple organ failure and even death. One characteristic of shock is low blood pressure which is managed with drugs called vasopressors. Most frequently used vasopressors are noradrenaline, vasopressin and recently also angiotensin II. Angiotensin II is present in the body and has a physiological role in maintaining blood pressure in healthy persons. Renin is an enzyme and a key factor in angiotensin II production in the body. In patients with shock, there is a lack of angiotensin II and an excess of renin in the body. Due to the literature renin has the potential to be a marker of severity of shock. Synthetic angiotensin II is used in patients with shock in whom we cannot normalize the blood pressure with noradrenaline and vasopressin. Regarding scientific data, the use of synthetic angiotensin II reduces the dose of noradrenaline and vasopressin and the incidence of acute kidney injury. The aim of our study is to find out what is the relation between the concentration of renin before and 6 hours after the start of using angiotensin II in patients with shock and their clinical outcome. Since not all patients with shock are responding to angiotensin II, the aim of our study is also to find out which patients could benefit most from synthetic angiotensin II.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients with distributive shock lasting < 72 hours
a goal mean arterial pressure (65-85 mmHg) not achieved despite optimal fluid resuscitation (30 ml/kg cristalloid) and an infusion of at least noradrenaline 0.3 mcg/kg/min and vasopressin 0.03 IE/min
the patient did not get angiotensin II before
predicted survival is >24h
Disqualifiers
burns >20% body area
acute coronary syndrome
bronchospasm
liver disease (MELD ≥30)
Trial population
Patients (≥ 18 years old) with distributive shock (\<72 hours duration) regardless of etiology without limitations for treatment and a predicted survival \>24 hours.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Association between 0-6-hour change in relative renin ratio (ΔRRR = RRR6h - RRR0h) and 28-day organ failure-free days (without vasopressors, mechanical ventilation and renal replacement therapy (RRT))
days alive without the need of vasopressors, ventilators, or dialysis
Secondary outcomes
Association between ΔRRR and 28-day ICU free days
28 minus ICU stay
Association between ΔRRR and vasopressor free days
time without vasopressors
Association between ΔRRR and cumulative dose of vasopressors expressed in norepinephrine equivalent dose (NED)
cumulative dose of vasopressors expressed in norepinephrine equivalent dose (NED)
Association between ΔRRR and the RRT free days
28 minus days with RRT (renal replacement therapy)
Sponsors and contacts
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