Angiotensin II Stress Test. Renin Kinetics During Treatment of Vasoplegic Shock With Angiotensin II.
NCT ID: NCT06539234
Last Updated: 2024-08-06
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Total Enrollment
80 participants
Study Classification
OBSERVATIONAL
Study Start Date
2024-08-01
Study Completion Date
2026-09-01
Brief Summary
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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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Detailed Description
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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.
Conditions
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Shock
Vasoplegic Syndrome
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University Medical Centre Maribor
OTHER
Sponsor Role
lead
Responsible Party
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Andreja Möller Petrun, MD, PhD
Assist. Prof. Andreja Möller Petrun, MD, PhD
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Andreja Möller Petrun, PhD
Role: STUDY_CHAIR
University Medical Centre Maribor
Locations
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Medical ICU, University Medical Centre Maribor
Maribor, , Slovenia
Site Status
RECRUITING
Surgical ICU, University Medical Centre Maribor
Maribor, , Slovenia
Site Status
RECRUITING
Countries
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Slovenia
Central Contacts
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Facility Contacts
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References
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Reference Type
RESULT
Zelniker TA, Kaya Z, Gamerdinger E, Spaich S, Stiepak J, Giannitsis E, Katus HA, Preusch MR. Relationship between markers of inflammation and hemodynamic stress and death in patients with out-of-hospital cardiac arrest. Sci Rep. 2021 May 11;11(1):9954. doi: 10.1038/s41598-021-88474-3.
Reference Type
RESULT
Meersch M, Weiss R, Massoth C, Kullmar M, Saadat-Gilani K, Busen M, Chawla L, Landoni G, Bellomo R, Gerss J, Zarbock A. The Association Between Angiotensin II and Renin Kinetics in Patients After Cardiac Surgery. Anesth Analg. 2022 May 1;134(5):1002-1009. doi: 10.1213/ANE.0000000000005953.
Reference Type
RESULT
Kullmar M, Saadat-Gilani K, Weiss R, Massoth C, Lagan A, Cortes MN, Gerss J, Chawla LS, Fliser D, Meersch M, Zarbock A. Kinetic Changes of Plasma Renin Concentrations Predict Acute Kidney Injury in Cardiac Surgery Patients. Am J Respir Crit Care Med. 2021 May 1;203(9):1119-1126. doi: 10.1164/rccm.202005-2050OC.
Reference Type
RESULT
Eleuteri D, Montini L, Cutuli SL, Rossi C, Alcaro F, Antonelli M. Renin-angiotensin system dysregulation in critically ill patients with acute respiratory distress syndrome due to COVID-19: a preliminary report. Crit Care. 2021 Mar 1;25(1):91. doi: 10.1186/s13054-021-03507-7. No abstract available.
Reference Type
RESULT
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UKC-MB-KME-33/24
Identifier Type: -
Identifier Source: org_study_id
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