ShockTENSINTESTNCT06539234
Angiotensin II Stress Test. Renin Kinetics During Treatment of Vasoplegic Shock With Angiotensin II.
An observational study of Shock and Vasoplegic Syndrome, run by University Medical Centre Maribor at 2 sites in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock, Vasoplegic Syndrome
- How many people
- 121 participants
- Where
- 2 sitesSlovenia
- Study dates
- 1 Aug 2024to 1 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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%
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia2 sites, 2 recruiting
- Recruiting
Medical ICU, University Medical Centre Maribor
Maribor, 2000
Andrej Markota, PhD, +38623212472, andrej.markota@ukc-mb.si
- Recruiting
Surgical ICU, University Medical Centre Maribor
Maribor, 2000
Andreja Möller Petrun, PhD, drejapet@web.de
About this study
Official 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.
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.
Read the 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.
- Conditions
- Shock, Vasoplegic Syndrome
- Keywords
- shock, distributive, angiotensin II, renin, shock, septic, vasoplegia
- Medical subject headings
- Shock, Vasoplegia, Shock, Septic
What is being measured
The primary outcome is the main question the study is designed to answer.
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))
days alive without the need of vasopressors, ventilators, or dialysis
Measured: 0-28 days
Secondary outcomes (9)
Association between ΔRRR and 28-day ICU free days
28 minus ICU stay
Measured: 0-28 days
Association between ΔRRR and vasopressor free days
time without vasopressors
Measured: 0-28 days
Association between ΔRRR and cumulative dose of vasopressors expressed in norepinephrine equivalent dose (NED)
cumulative dose of vasopressors expressed in norepinephrine equivalent dose (NED)
Measured: 0-28 days
Association between ΔRRR and the RRT free days
28 minus days with RRT (renal replacement therapy)
Measured: 0-28 days
Association between ΔRRR and invasive mechanical ventilation free days
28 minus days with invasive mechanical ventilation
Measured: 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.
Measured: 0-1 hour
Comparison of the prognostic performance of renin and lactate at 0 and 6 hours for 28-day mortality.
Measured: 0-6 hour
product ( [renin] x [lactate]) at baseline and 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
Measured: 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
Change in norepinephrine-base dose equivalent (NED) at baseline and 1 hour predicts mortality
Measured: change in norepinephrine-base dose equivalent (NED) from start of angiotensin II infusion (baseline) and 1 hour after start of angiotensin II infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start1 Aug 2024
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (63)Papers the sponsor has linked to this study.
- Other trials for ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 121 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Maribor
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreja Möller Petrun, MD, PhD, University Medical Centre Maribor
- Investigators
- Andreja Möller Petrun, PhD, Study chair, University Medical Centre Maribor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539234
- Sponsor's protocol ID
- UKC-MB-KME-33/24
- Acronym
- TENSINTEST
- Status last verified
- Sep 2026
- First submitted
- 1 Aug 2024
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yehya N, Harhay MO, Curley MAQ, Schoenfeld DA, Reeder RW. Reappraisal of Ventilator-Free Days in Critical Care Research. Am J Respir Crit Care Med. 2019 Oct 1;200(7):828-836. doi: 10.1164/rccm.201810-2050CP.
PubMed 31034248Auriemma CL, Taylor SP, Harhay MO, Courtright KR, Halpern SD. Hospital-Free Days: A Pragmatic and Patient-centered Outcome for Trials among Critically and Seriously Ill Patients. Am J Respir Crit Care Med. 2021 Oct 15;204(8):902-909. doi: 10.1164/rccm.202104-1063PP. No abstract available.
PubMed 34319848De Backer D, Cecconi M, Chew MS, Hajjar L, Monnet X, Ospina-Tascon GA, Ostermann M, Pinsky MR, Vincent JL. A plea for personalization of the hemodynamic management of septic shock. Crit Care. 2022 Dec 1;26(1):372. doi: 10.1186/s13054-022-04255-y.
PubMed 36457089Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. No abstract available.
PubMed 34599691Vincent JL, Singer M, Einav S, Moreno R, Wendon J, Teboul JL, Bakker J, Hernandez G, Annane D, de Man AME, Monnet X, Ranieri VM, Hamzaoui O, Takala J, Juffermans N, Chiche JD, Myatra SN, De Backer D. Equilibrating SSC guidelines with individualized care. Crit Care. 2021 Nov 17;25(1):397. doi: 10.1186/s13054-021-03813-0. No abstract available.
PubMed 34789298Maslove DM, Tang B, Shankar-Hari M, Lawler PR, Angus DC, Baillie JK, Baron RM, Bauer M, Buchman TG, Calfee CS, Dos Santos CC, Giamarellos-Bourboulis EJ, Gordon AC, Kellum JA, Knight JC, Leligdowicz A, McAuley DF, McLean AS, Menon DK, Meyer NJ, Moldawer LL, Reddy K, Reilly JP, Russell JA, Sevransky JE, Seymour CW, Shapiro NI, Singer M, Summers C, Sweeney TE, Thompson BT, van der Poll T, Venkatesh B, Walley KR, Walsh TS, Ware LB, Wong HR, Zador ZE, Marshall JC. Redefining critical illness. Nat Med. 2022 Jun;28(6):1141-1148. doi: 10.1038/s41591-022-01843-x. Epub 2022 Jun 17.
PubMed 35715504Suzuki Y, Ruiz-Ortega M, Lorenzo O, Ruperez M, Esteban V, Egido J. Inflammation and angiotensin II. Int J Biochem Cell Biol. 2003 Jun;35(6):881-900. doi: 10.1016/s1357-2725(02)00271-6.
PubMed 12676174Laghlam D, Jozwiak M, Nguyen LS. Renin-Angiotensin-Aldosterone System and Immunomodulation: A State-of-the-Art Review. Cells. 2021 Jul 13;10(7):1767. doi: 10.3390/cells10071767.
PubMed 34359936Bitker L, Burrell LM. Classic and Nonclassic Renin-Angiotensin Systems in the Critically Ill. Crit Care Clin. 2019 Apr;35(2):213-227. doi: 10.1016/j.ccc.2018.11.002. Epub 2019 Jan 28.
PubMed 30784605Paul M, Poyan Mehr A, Kreutz R. Physiology of local renin-angiotensin systems. Physiol Rev. 2006 Jul;86(3):747-803. doi: 10.1152/physrev.00036.2005.
PubMed 16816138Correa TD, Takala J, Jakob SM. Angiotensin II in septic shock. Crit Care. 2015 Mar 16;19(1):98. doi: 10.1186/s13054-015-0802-3.
PubMed 25886853Garcia B, Zarbock A, Bellomo R, Legrand M. The alternative renin-angiotensin system in critically ill patients: pathophysiology and therapeutic implications. Crit Care. 2023 Nov 20;27(1):453. doi: 10.1186/s13054-023-04739-5.
PubMed 37986086Hall A, Busse LW, Ostermann M. Angiotensin in Critical Care. Crit Care. 2018 Mar 20;22(1):69. doi: 10.1186/s13054-018-1995-z.
PubMed 29558991Bellomo R, Zarbock A, Landoni G. Angiotensin II. Intensive Care Med. 2024 Feb;50(2):279-282. doi: 10.1007/s00134-023-07290-7. Epub 2024 Jan 8. No abstract available.
PubMed 38189932Forrester SJ, Booz GW, Sigmund CD, Coffman TM, Kawai T, Rizzo V, Scalia R, Eguchi S. Angiotensin II Signal Transduction: An Update on Mechanisms of Physiology and Pathophysiology. Physiol Rev. 2018 Jul 1;98(3):1627-1738. doi: 10.1152/physrev.00038.2017.
PubMed 29873596
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT06539234
- Acronym / sponsor ID
- TENSINTEST / UKC-MB-KME-33/24
- Conditions
- Shock, Vasoplegic Syndrome
- Keywords
- shock, distributive, angiotensin II, renin, shock, septic, vasoplegia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 121 participants (estimated)
- Lead sponsor
- University Medical Centre MariborUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- burns >20% body area
- acute coronary syndrome
- bronchospasm
- liver disease (MELD ≥30)
- severe acute bleeding (need for 4 or more units of concentrated erythrocyte)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
9 secondary outcomes
Association between ΔRRR and 28-day ICU free days
Time frame: 0-28 days
Association between ΔRRR and vasopressor free days
Time frame: 0-28 days
Association between ΔRRR and cumulative dose of vasopressors expressed in norepinephrine equivalent dose (NED)
Time frame: 0-28 days
Association between ΔRRR and the RRT free days
Time frame: 0-28 days
Association between ΔRRR and invasive mechanical ventilation free days
Time frame: 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
Comparison of the prognostic performance of renin and lactate at 0 and 6 hours for 28-day mortality.
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Background: PubMed 31034248Yehya N, Harhay MO, Curley MAQ, Schoenfeld DA, Reeder RW. Reappraisal of Ventilator-Free Days in Critical Care Research. Am J Respir Crit Care Med. 2019 Oct 1;200(7):828-836. doi: 10.1164/rccm.201810-2050CP.
- Background: PubMed 34319848Auriemma CL, Taylor SP, Harhay MO, Courtright KR, Halpern SD. Hospital-Free Days: A Pragmatic and Patient-centered Outcome for Trials among Critically and Seriously Ill Patients. Am J Respir Crit Care Med. 2021 Oct 15;204(8):902-909. doi: 10.1164/rccm.202104-1063PP. No abstract available.
- Background: PubMed 36457089De Backer D, Cecconi M, Chew MS, Hajjar L, Monnet X, Ospina-Tascon GA, Ostermann M, Pinsky MR, Vincent JL. A plea for personalization of the hemodynamic management of septic shock. Crit Care. 2022 Dec 1;26(1):372. doi: 10.1186/s13054-022-04255-y.
- Background: PubMed 34599691Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. No abstract available.
- Background: PubMed 34789298Vincent JL, Singer M, Einav S, Moreno R, Wendon J, Teboul JL, Bakker J, Hernandez G, Annane D, de Man AME, Monnet X, Ranieri VM, Hamzaoui O, Takala J, Juffermans N, Chiche JD, Myatra SN, De Backer D. Equilibrating SSC guidelines with individualized care. Crit Care. 2021 Nov 17;25(1):397. doi: 10.1186/s13054-021-03813-0. No abstract available.
- Background: PubMed 35715504Maslove DM, Tang B, Shankar-Hari M, Lawler PR, Angus DC, Baillie JK, Baron RM, Bauer M, Buchman TG, Calfee CS, Dos Santos CC, Giamarellos-Bourboulis EJ, Gordon AC, Kellum JA, Knight JC, Leligdowicz A, McAuley DF, McLean AS, Menon DK, Meyer NJ, Moldawer LL, Reddy K, Reilly JP, Russell JA, Sevransky JE, Seymour CW, Shapiro NI, Singer M, Summers C, Sweeney TE, Thompson BT, van der Poll T, Venkatesh B, Walley KR, Walsh TS, Ware LB, Wong HR, Zador ZE, Marshall JC. Redefining critical illness. Nat Med. 2022 Jun;28(6):1141-1148. doi: 10.1038/s41591-022-01843-x. Epub 2022 Jun 17.
- Background: PubMed 12676174Suzuki Y, Ruiz-Ortega M, Lorenzo O, Ruperez M, Esteban V, Egido J. Inflammation and angiotensin II. Int J Biochem Cell Biol. 2003 Jun;35(6):881-900. doi: 10.1016/s1357-2725(02)00271-6.
- Background: PubMed 34359936Laghlam D, Jozwiak M, Nguyen LS. Renin-Angiotensin-Aldosterone System and Immunomodulation: A State-of-the-Art Review. Cells. 2021 Jul 13;10(7):1767. doi: 10.3390/cells10071767.
- Background: PubMed 30784605Bitker L, Burrell LM. Classic and Nonclassic Renin-Angiotensin Systems in the Critically Ill. Crit Care Clin. 2019 Apr;35(2):213-227. doi: 10.1016/j.ccc.2018.11.002. Epub 2019 Jan 28.
- Background: PubMed 16816138Paul M, Poyan Mehr A, Kreutz R. Physiology of local renin-angiotensin systems. Physiol Rev. 2006 Jul;86(3):747-803. doi: 10.1152/physrev.00036.2005.
- Background: PubMed 25886853Correa TD, Takala J, Jakob SM. Angiotensin II in septic shock. Crit Care. 2015 Mar 16;19(1):98. doi: 10.1186/s13054-015-0802-3.
- Background: PubMed 37986086Garcia B, Zarbock A, Bellomo R, Legrand M. The alternative renin-angiotensin system in critically ill patients: pathophysiology and therapeutic implications. Crit Care. 2023 Nov 20;27(1):453. doi: 10.1186/s13054-023-04739-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andreja Möller Petrun, PhD study chair
University Medical Centre Maribor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shock and Vasoplegic Syndrome, run by University Medical Centre Maribor at 2 sites in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andreja Möller Petrun, PhD (+38623211571, drejapet@web.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06539234, which also lists 63 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.