Angiotensin II Stress Test. Renin Kinetics During Treatment of Vasoplegic Shock With Angiotensin II.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Medical Centre Maribor

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Association between ΔRRR and 28-day ICU free days

28 minus ICU stay

Time frame
0-28 days
2

Association between ΔRRR and vasopressor free days

time without vasopressors

Time frame
0-28 days
3

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
4

Association between ΔRRR and the RRT free days

28 minus days with RRT (renal replacement therapy)

Time frame
0-28 days

Other outcomes

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