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

August 1, 2024 updated by: Andreja Möller Petrun, MD, PhD, University Medical Centre Maribor

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

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Andreja Möller Petrun, PhD
  • Phone Number: +38623211571
  • Email: drejapet@web.de

Study Locations

  • Slovenia
      • Maribor, Slovenia, 2000
        • Recruiting
        • Medical ICU, University Medical Centre Maribor
        • Contact:
      • Maribor, Slovenia, 2000
        • Recruiting
        • Surgical ICU, University Medical Centre Maribor
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
organ failure free days
Time Frame: 0-30 days
days alive without the need of vasopressors, ventilators, or dialysis
0-30 days
ICU free days
Time Frame: 0-30 days
30 minus the number of days in the ICU
0-30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of the need for vasopressors
Time Frame: 0-30 days
time in which vasopressors are needed
0-30 days
mechanical ventilation need
Time Frame: 0-30 days
time of mechanical ventilation (invasive and/or noninvasive)
0-30 days
dyalisis need
Time Frame: 0-30 days
time of eventual need for dyalisi´s
0-30 days
renin trend
Time Frame: 0-6 hours
renin concentration before and 6 hours after the start of angiotensin II infusion
0-6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Maribor

Investigators

  • Study Chair: Andreja Möller Petrun, PhD, University Medical Centre Maribor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

August 1, 2024

First Submitted That Met QC Criteria

August 1, 2024

First Posted (Actual)

August 6, 2024

Study Record Updates

Last Update Posted (Actual)

August 6, 2024

Last Update Submitted That Met QC Criteria

August 1, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UKC-MB-KME-33/24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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