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

September 12, 2026 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 at least 0,3 mcg/kg/min and vasopressin 0,03 IE/min not achieving an appropriate mean arterial pressure (65-85 mmHg) despite fluid resuscuitation 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)

121

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 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
  • 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
  • active venous or arterial thromboembolic disease
  • the need for daily dose of hydrocortisone 500 mg or more
  • ECMO
  • cardiac index <l/min/m2 (defined by echocardiography or invasive methods)
  • central venous oxygen saturation (SCVO2) >70%

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
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))
Time Frame: 0-28 days
days alive without the need of vasopressors, ventilators, or dialysis
0-28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between ΔRRR and 28-day ICU free days
Time Frame: 0-28 days
28 minus ICU stay
0-28 days
Association between ΔRRR and vasopressor free days
Time Frame: 0-28 days
time without vasopressors
0-28 days
Association between ΔRRR and cumulative dose of vasopressors expressed in norepinephrine equivalent dose (NED)
Time Frame: 0-28 days
cumulative dose of vasopressors expressed in norepinephrine equivalent dose (NED)
0-28 days
Association between ΔRRR and the RRT free days
Time Frame: 0-28 days
28 minus days with RRT (renal replacement therapy)
0-28 days
Association between ΔRRR and invasive mechanical ventilation free days
Time Frame: 0-28 days
28 minus days with invasive mechanical ventilation
0-28 days
Determination of responders and nonresponders based on calculation of the ratio between change in MAP between 0 and 1 hours of protocol to the change in total vasopressor NED between 0 and 1 hours of protocol.
Time Frame: 0-1 hour
0-1 hour
Comparison of the prognostic performance of renin and lactate at 0 and 6 hours for 28-day mortality.
Time Frame: 0-6 hour
0-6 hour
product ( [renin] x [lactate]) at baseline and 6 hours after start of angiotensin II infusion
Time Frame: baseline - just before start of angiotensin II infusion; 6 hours - 6 hours after start of angiotensin II infusion
Determination if the product ( [renin] x [lactate]) at baseline and 6 hours after start of angiotensin II infusion predicts 28-day organ failure free days, mortality, cumulative dose of vasopressors expressed in NED, renal replacement therapy and mechanical ventilation
baseline - just before start of angiotensin II infusion; 6 hours - 6 hours after start of angiotensin II infusion
Change in total norepinephrine-base dose equivalen (NED) at baseline and 1 hour predicts mortality
Time Frame: change in norepinephrine-base dose equivalent (NED) from start of angiotensin II infusion (baseline) and 1 hour after start of angiotensin II infusion
Change in norepinephrine-base dose equivalent (NED) at baseline and 1 hour predicts mortality
change in norepinephrine-base dose equivalent (NED) from start of angiotensin II infusion (baseline) and 1 hour after start of angiotensin II infusion

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, 2027

Study Completion (Estimated)

September 1, 2027

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)

September 16, 2026

Last Update Submitted That Met QC Criteria

September 12, 2026

Last Verified

September 1, 2026

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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