NCT06539234 Angiotensin II Stress Test. Renin Kinetics During Treatment of Vasoplegic Shock With Angiotensin II.
| NCT ID | NCT06539234 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Medical Centre Maribor |
| Condition | Shock |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2024-08-01 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * patients with distributive shock lasting \< 72 hours * a goal mean arterial pressure (65-85 mmHg) not achieved despite 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 * no limitations for active treatment Exclusion Criteria: * burns \>20% body area * acute coronary syndrome * bronchospasm * liver disease (MELD ≥30) * severe acute bleeding (need for 4 or more units of concentrated erythrocyte) * acute mesenteric ischemia * aortic dissection * leucopenia \<1000/mm3 * pregnancy * Raynaud disease, systemic sclerosis, vasospastic disease * the need for daily dose of hydrocortisone 500 mg or more * ECMO
Contact & Investigator
Andreja Möller Petrun, PhD
STUDY CHAIR
University Medical Centre Maribor
Frequently Asked Questions
Who can join the NCT06539234 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06539234 currently recruiting?
Yes, NCT06539234 is actively recruiting participants. Contact the research team at drejapet@web.de for enrollment information.
Where is the NCT06539234 trial being conducted?
This trial is being conducted at Maribor, Slovenia, Maribor, Slovenia.
Who is sponsoring the NCT06539234 clinical trial?
NCT06539234 is sponsored by University Medical Centre Maribor. The principal investigator is Andreja Möller Petrun, PhD at University Medical Centre Maribor. The trial plans to enroll 80 participants.