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

NCT06539234 | Recruiting

• 1 other identifier: UKC-MB-KME-33/24
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Shock; Vasoplegic Syndrome

Keywords

shock, distributive; angiotensin II; renin; shock, septic; vasoplegia

Outcome Measures

Primary Outcomes (2)

• organ failure free days

  days alive without the need of vasopressors, ventilators, or dialysis

  0-30 days

• ICU free days

  30 minus the number of days in the ICU

  0-30 days

Secondary Outcomes (4)

• duration of the need for vasopressors

  0-30 days

• mechanical ventilation need

  0-30 days

• dyalisis need

  0-30 days

• renin trend

  0-6 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients (≥ 18 years old) with distributive shock (\<72 hours duration) regardless of etiology without limitations for treatment and a predicted survival \>24 hours.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Centre Maribor: lead

Study Sites (2)

Medical ICU, University Medical Centre Maribor

Maribor, 2000, Slovenia

RECRUITING

Surgical ICU, University Medical Centre Maribor

Maribor, 2000, Slovenia

RECRUITING

Related Publications (63)

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MeSH Terms

Conditions

Shock; Vasoplegia; Shock, Septic

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation

Study Officials

• Andreja Möller Petrun, PhD

  University Medical Centre Maribor

  STUDY CHAIR

Central Study Contacts

Andreja Möller Petrun, PhD

CONTACT

+38623211571; drejapet@web.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof. Andreja Möller Petrun, MD, PhD

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 6, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

SL (2)