Vasopressin Use in Septic Shock From Türkiye

Completed

• Conditions: Septic Shock; Vasodilatory Shock; Critical Illness Sepsis, Severe; Critical Illness; Intensive Care Medicine; Vasopressor Therapy

• Registration Number: NCT06953297
• Lead Sponsor: Karadeniz Technical University

Brief Summary

The goal of this observational study is to examine the early hemodynamic effects and clinical outcomes of vasopressin use in patients with septic shock. The study aims to compare adult ICU patients who received norepinephrine alone versus those who received vasopressin in addition to norepinephrine.

The main question it aims to answer is:

Does adding vasopressin to norepinephrine improve blood pressure, lactate levels, and survival in patients with septic shock?

Researchers used retrospective medical records of patients treated between January and December 2024. Data such as blood pressure, heart rate, lactate levels, and mortality were collected and analyzed to assess treatment response and outcomes.

Detailed Description

This is a single-center, retrospective observational cohort study designed to evaluate the clinical impact of adjunctive vasopressin therapy in adult patients with septic shock. The study protocol was developed to assess early hemodynamic responses and mortality outcomes associated with vasopressin use in real-world intensive care settings in Türkiye.

A total of 146 adult patients admitted to the intensive care unit (ICU) between January 1 and December 15, 2024, were included in the study. All patients fulfilled Sepsis-3 criteria for septic shock and received norepinephrine as the primary vasopressor agent. Among these, 33 patients received vasopressin in addition to norepinephrine, while the remaining patients were managed with norepinephrine alone.

The primary objective of the study is to describe early hemodynamic changes following vasopressin administration, specifically focusing on changes in:

Mean arterial pressure (MAP),

Heart rate (HR),

Serum lactate levels, and

Norepinephrine dose requirement,

within the first 6 and 24 hours of vasopressin initiation.

The secondary objective is to assess all-cause mortality among patients who received norepinephrine alone versus those treated with norepinephrine plus vasopressin.

All data were collected retrospectively from the institution's electronic health record system. Patients who received dopamine or epinephrine either prior to or concurrently with vasopressin were excluded to ensure homogeneity of the treatment groups. No randomization or prospective allocation was involved, and all treatment decisions were made by the clinical ICU team as part of routine medical care.

Statistical analyses will include descriptive and inferential methods to compare outcomes between the two groups, including Mann-Whitney U test, Chi-square test, Friedman's test, and Kaplan-Meier survival analysis. This study aims to describe the protocol and methodology of a real-world, retrospective analysis and does not intend to present prospective results at this stage.

The protocol was approved by the institutional ethics committee and adheres to international standards for human subject research.

Study Timeline

• Study Start: 2024-01-01
• Primary Completion: 2024-12-15
• Study Completion: 2025-01-15
• Status Verified: 2025-04
• Study First Submitted: 2025-04-17
• Study First Submitted QC: 2025-04-23
• Last Update Submitted: 2025-04-23
• Study First Posted: 2025-05-01
• Last Update Posted: 2025-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

• Adult patients (≥18 years old) admitted to the intensive care unit (ICU)
• Diagnosed with septic shock according to Sepsis-3 criteria
• Treated with norepinephrine as the initial vasopressor
• Received norepinephrine alone or norepinephrine with adjunctive vasopressin
• Admitted between January 1 and December 15, 2024

Exclusion Criteria

• Patients younger than 18 years
• Patients who received epinephrine or dopamine prior to or along with vasopressin
• Patients with incomplete clinical or hemodynamic data
• Readmitted ICU patients during the same hospitalization
• Patients with do-not-resuscitate (DNR) orders at ICU admission

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Mean Arterial Pressure (MAP) Within 24 Hours After Vasopressin Initiation	6 hours after vasopressor initiation	Mean arterial pressure (MAP) will be recorded at vasopressin initiation and at 0, 2 and 6 hours following the first dose. The primary outcome is the absolute change in MAP from baseline to 24 hours in patients receiving adjunctive vasopressin compared to those receiving norepinephrine alone.

Secondary Outcome Measures

Name	Time	Method
All-Cause Mortality	Up to Day 28 after ICU admission	Vital status (alive or deceased) at day 28 after ICU admission will be collected from medical records to compare mortality between treatment groups.
Change in Serum Lactate Levels	6 hours	Serum lactate concentrations will be measured at vasopressin initiation, and at 0, 2 and 6 hours. The study will assess reductions in lactate as a marker of improved perfusion.
Change in Norepinephrine Dose After Vasopressin Initiation	6 hours	Norepinephrine infusion dose (mcg/kg/min) will be measured at vasopressin initiation and at 0, 2 and 6 hours. The outcome is the reduction in dose over time indicating vasopressor-sparing effect.

Trial Locations

Locations (1)

Karadeniz Technical University, Faculty of Medicine; 🇹🇷 Trabzon, Turkey