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NCT Number: NCT06539234

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical ICU, University Medical Centre Maribor, Maribor, Slovenia

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About this study

In patients with distributive shock (≥18 years) with noradrenaline >0,3 mcg/kg/min and vasopressin >0,03 IE/min not achieving an appropriate mean arterial pressure (65-85 mmHg) 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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. organ failure free days

    Time frame: 0-30 days

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

  2. ICU free days

    Time frame: 0-30 days

    30 minus the number of days in the ICU

Secondary outcomes

  1. duration of the need for vasopressors

    Time frame: 0-30 days

    time in which vasopressors are needed

  2. mechanical ventilation need

    Time frame: 0-30 days

    time of mechanical ventilation (invasive and/or noninvasive)

  3. dyalisis need

    Time frame: 0-30 days

    time of eventual need for dyalisi´s

  4. renin trend

    Time frame: 0-6 hours

    renin concentration before and 6 hours after the start of angiotensin II infusion

Study contacts

Contact information is provided by the study sponsor or research team.

Andreja Möller Petrun, PhD

CONTACT

[email protected]

+38623211571

Sponsors and collaborators

Lead sponsor

University Medical Centre Maribor

Other

Registry information

Official study title

Angiotensin II Stress Test. Renin Kinetics During Treatment of Vasoplegic Shock With Angiotensin II in Relation to Hemodynamic Response to Treatment With Angiotensin II.

Acronym: TENSINTEST

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 6, 2024
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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