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.
In patients with distributive shock (≥18 years) with noradrenaline at least 0,3 mcg/kg/min and vasopressin 0,03 IE/min not achieving an appropriate mean arterial pressure (65-85 mmHg) despite fluid resuscuitation an angiotensin II infusion will be started at 20 ng/kg/min and after that adjusted to a max dose of 40 ng/kg/min if needed. Before the infusion and 6 hours after the start of angiotensin II infusion a blood sample will be drawn to determine the renin concentration. The primary outcome will be organ failure free days and ICU free days. Secondary outcome will be the need for vasopressors, dialysis, mechanical ventilation, trend of renin concentration.
Study Type
OBSERVATIONAL
Enrollment
121
Medical ICU, University Medical Centre Maribor
Maribor, Slovenia
RECRUITINGSurgical ICU, University Medical Centre Maribor
Maribor, Slovenia
RECRUITINGAssociation 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
Time frame: 0-28 days
Association between ΔRRR and 28-day ICU free days
28 minus ICU stay
Time frame: 0-28 days
Association between ΔRRR and vasopressor free days
time without vasopressors
Time frame: 0-28 days
Association between ΔRRR and cumulative dose of vasopressors expressed in norepinephrine equivalent dose (NED)
cumulative dose of vasopressors expressed in norepinephrine equivalent dose (NED)
Time frame: 0-28 days
Association between ΔRRR and the RRT free days
28 minus days with RRT (renal replacement therapy)
Time frame: 0-28 days
Association between ΔRRR and invasive mechanical ventilation free days
28 minus days with invasive mechanical ventilation
Time frame: 0-28 days
Determination of responders and nonresponders based on calculation of the ratio between change in MAP between 0 and 1 hours of protocol to the change in total vasopressor NED between 0 and 1 hours of protocol.
Time frame: 0-1 hour
Comparison of the prognostic performance of renin and lactate at 0 and 6 hours for 28-day mortality.
Time frame: 0-6 hour
product ( [renin] x [lactate]) at baseline and 6 hours after start of angiotensin II infusion
Determination if the product ( \[renin\] x \[lactate\]) at baseline and 6 hours after start of angiotensin II infusion predicts 28-day organ failure free days, mortality, cumulative dose of vasopressors expressed in NED, renal replacement therapy and mechanical ventilation
Time frame: baseline - just before start of angiotensin II infusion; 6 hours - 6 hours after start of angiotensin II infusion
Change in total norepinephrine-base dose equivalen (NED) at baseline and 1 hour predicts mortality
Change in norepinephrine-base dose equivalent (NED) at baseline and 1 hour predicts mortality
Time frame: change in norepinephrine-base dose equivalent (NED) from start of angiotensin II infusion (baseline) and 1 hour after start of angiotensin II infusion
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