An observational study in Shock and Vasoplegic Syndrome, sponsored by University Medical Centre Maribor. Recruiting at 2 sites in Slovenia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by University Medical Centre Maribor · Observational
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.
487 studies on the registry are indexed under Shock; 107 are open to participants now.
This study's planned enrollment of 121 is above the median of 100 across 247 observational studies indexed under Shock.
Browse Shock studies →University Medical Centre Maribor is the lead sponsor of 36 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients (≥ 18 years old) with distributive shock (\<72 hours duration) regardless of etiology without limitations for treatment and a predicted survival >24 hours.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
Plan to share: No
Started Aug 2024 (actual). Primary completion is estimated for Jun 2027, 34 months after the start.
Of 120 non-industry observational studies under Shock, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 52. This study's planned 34 months is above that.
Counting every sponsor, half of 127 studies reached it within 26 months; a quarter within 12 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
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University Medical Centre Maribor