Actively Recruiting

Age: 18Years +
All Genders
ID06539234

Angiotensin II Stress Test and Renin Kinetics During Treatment of Vasoplegic Shock in Relation to Response to Angiotensin II

Led by University Medical Centre Maribor · Updated on 2024-08-06

80

Participants Needed

2

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Shock is a serious condition that can cause multiple organs to fail and can be life-threatening. This research focuses on patients with distributive shock who have low blood pressure despite receiving common vasopressor drugs like noradrenaline and vasopressin. The study evaluates the relationship between renin levels, an enzyme involved in blood pressure regulation, and the use of synthetic angiotensin II, a drug given when standard vasopressors are not enough. Researchers aim to understand which patients might benefit most from angiotensin II treatment based on renin concentration changes. Participants who are adults with distributive shock not responding adequately to noradrenaline and vasopressin will receive an infusion of angiotensin II starting at 20 ng/kg/min, adjustable up to 40 ng/kg/min as needed. Blood samples will be taken before the infusion and six hours afterwards to measure renin levels. This observational study will track how renin changes during treatment and how it relates to clinical outcomes. During the study, researchers will monitor the number of days patients remain free from organ failure and days spent outside the intensive care unit over 30 days. They will also assess the duration of vasopressor need, the requirement for mechanical ventilation or dialysis, and trends in renin levels within the first six hours. The study participation will last up to 30 days, with close observation of patient responses to angiotensin II and their overall clinical progress.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with distributive shock lasting less than 72 hours
  • Mean arterial pressure between 65-85 mmHg not achieved despite noradrenaline infusion of at least 0.3 mcg/kg/min and vasopressin infusion of at least 0.03 IE/min
  • No previous treatment with angiotensin II
  • Predicted survival greater than 24 hours
  • No limitations for active treatment
Not Eligible

You will not qualify if you...

  • Burns covering more than 20% of body surface area
  • Acute coronary syndrome
  • Bronchospasm
  • Liver disease with MELD score 30 or higher
  • Severe acute bleeding requiring 4 or more units of concentrated erythrocytes
  • Acute mesenteric ischemia
  • Aortic dissection
  • Leucopenia less than 1000/mm3
  • Pregnancy
  • Raynaud disease, systemic sclerosis, or other vasospastic diseases
  • Need for daily hydrocortisone dose of 500 mg or more
  • Use of extracorporeal membrane oxygenation (ECMO)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - Up to 72 hours of distributive shock

Participants are screened for eligibility to participate in the trial.

1 screening visit (in-person)

Monitoring

Duration - 6 hours

Participants who receive angiotensin II infusion are observed with blood samples collected to assess renin concentration before infusion and 6 hours after infusion start.

2 blood sample collections within 6 hours

Long-term Monitoring

Duration - Up to 30 days

Participants are monitored for organ failure, ICU stay duration, and need for vasopressors, dialysis, and mechanical ventilation up to 30 days after treatment.

Ongoing observation without specified visit schedule

Trial Site Locations

Total: 2 locations

1

Medical ICU, University Medical Centre Maribor

Maribor, Slovenia, 2000

Actively Recruiting

2

Surgical ICU, University Medical Centre Maribor

Maribor, Slovenia, 2000

Actively Recruiting

Loading map...

Research Team

A

Andreja Möller Petrun, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

Similar Trials

Acutelines: a Large Biobank Aiming to Improve Early Recognit...

Acute Disease

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Hospital-Free Days: A Pragmatic and Patient-centered Outcome for Trials among Critically and Seriously Ill Patients.

Catherine L Auriemma, Stephanie P Taylor, Michael O Harhay...

https://pubmed.ncbi.nlm.nih.gov/34319848