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NCT Number: NCT06953297

Vasopressin Use in Septic Shock From Türkiye

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in Mean Arterial Pressure (MAP) Within 24 Hours After Vasopressin Initiation

    Time frame: 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 outcomes

  1. All-Cause Mortality

    Time frame: 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.

  2. Change in Serum Lactate Levels

    Time frame: 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.

  3. Change in Norepinephrine Dose After Vasopressin Initiation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Karadeniz Technical University

Other

Registry information

Official study title

Exploring Vasopressin Use in Septic Shock: A Retrospective Cohort Study From Türkiye

Acronym: (VASCO-TURK)

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
May 1, 2025
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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