Recruiting

Simultaneous Administration of Norepinephrine, Angiotensin II, and Vasopressin in Septic Shock Patients

What is being tested

Simultaneous administration of vasopressors

+ Successive administration of vasopressors

Other

Who is being recruted

Urogenital Diseases+14

+ Diabetes Insipidus

+ Endocrine System Diseases

Over 18 Years

+16 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2 & 3

Interventional

Study Start: December 2023

See protocol details

Summary

Principal SponsorUniversity Medical Centre Maribor

Study ContactŽiga Kalamar, MDMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: December 23, 2023

Actual date on which the first participant was enrolled.

This study focuses on exploring new ways to treat septic shock, a severe condition where the body's response to infection causes dangerously low blood pressure. It specifically looks at using a combination of medications called vasopressors, which help raise blood pressure, in patients suffering from this condition. The study compares two approaches: the traditional method of giving these drugs one after the other and a new method where three drugs—norepinephrine, angiotensin II, and vasopressin—are given together from the start. The goal is to see if this new method can more effectively stabilize blood pressure in these patients, improving their chances of recovery. Participants in this study will be divided into two groups. One group will receive the traditional treatment method, starting with norepinephrine and adding other drugs as needed. The other group will receive all three vasopressors at once, adjusting their doses every few minutes to maintain stable blood pressure. The study will observe how well each method works by measuring the patients' blood pressure and overall response to the treatment. This research aims to find the best strategy for treating septic shock, potentially leading to better outcomes for patients facing this serious condition.

Official TitleSimultaneous Administration of Norepinephrine, Angiotensin II, and Vasopressin in Septic Shock Patients

NCT06155812

Principal SponsorUniversity Medical Centre Maribor

Study ContactŽiga Kalamar, MDMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

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

Design Details

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesDiabetes InsipidusEndocrine System DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsInfectionsInflammationKidney DiseasesPathologic ProcessesPituitary DiseasesShockShock, SepticPathological Conditions, Signs and SymptomsUrologic DiseasesSystemic Inflammatory Response SyndromeSepsisFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

6 inclusion criteria required to participate

Adult patients (≥18 years).

Sepsis (an acute change in total Sequential Organ Failure Assessment (SOFA) score ≥2 points consequent to infection) with persisting hypotension requiring vasopressors to maintain MAP ≥65 mm Hg and having a serum lactate level >2 mmol/L despite adequate volume resuscitation (20-30ml/kg in 3 hours).

Vasopressor requirement of ≥0,15 μg/kg/min equivalent of norepinephrine base.

Patients are required to have central venous access and an arterial line present, and these are expected to remain present for at least the initial 72 hours of study.

Show More Criteria

10 exclusion criteria prevent from participating

Death expected <24 hours.

Pregnancy (suspected or confirmed).

Surgery expected for source of infection.

Inter-hospital transfer expected during first 72 hours of hospitalization.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Regimen: Simultaneous administration of norepinephrine, angiotensin II and vasopressin at equivalent starting doses (equivalent to approximately 0.05 mcg/kg/min of norepinephrine). Increments of 0.05 mcg/kg/min of equivalent doses of all three vasopressors every 3-5 min until MAP ≥ 65 mmHg is reached (vasopressin will be administered at a maximum dose of 0.03 IE/min, AT II will be administered at a maximum dose of 100 ng/kg/min). Initiation of additional vasoactive drugs (epinephrine, methylene blue or dopamine) as per clinical team decision. Initiation of inotropes (dobutamin, levosimendan, milrinone) as per clinical team decision.

Group II

Active Comparator

Regimen: Norepinephrine increases of 0.05-0.1 mcg/kg/min up to 0.5 mcg/kg/min, followed by vasopressin (administered at a fixed dose of 0.03 IE/min). If MAP remains \< 65 mmHg, norepinephrine will be titrated above dose of 0.5 mcg/kg/min until MAP ≥ 65 mmHg. Maximum norepinephrine dose as per clinical team decision. Initiation of additional vasoactive drugs (epinephrine, Ang II methylene blue or dopamine) as per clinical team decision. Initiation of inotropes (dobutamin, levosimendan, milrinone) as per clinical team decision.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

University Hospital Centre Zagreb

Zagreb, CroatiaOpen University Hospital Centre Zagreb in Google Maps

Recruiting

Medical intensive care unit UMC Maribor

Maribor, Slovenia

Recruiting

2 Study Centers