NCT06953297

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 1, 2025

Completed
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

12 months

First QC Date

April 17, 2025

Last Update Submit

April 23, 2025

Conditions

Keywords

Septic ShockVasopressinNorepinephrineVasopressor TherapyHemodynamic ResponseICUCritical Careintensive care unitMortalityLactateMean Arterial PressureTürkiye

Outcome Measures

Primary Outcomes (1)

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

    6 hours after vasopressor initiation

Secondary Outcomes (3)

  • All-Cause Mortality

    Up to Day 28 after ICU admission

  • Change in Serum Lactate Levels

    6 hours

  • Change in Norepinephrine Dose After Vasopressin Initiation

    6 hours

Study Arms (2)

Norepinephrine Only

Participants with septic shock who received norepinephrine as the sole vasopressor agent during their ICU stay. No adjunctive vasopressin or other vasopressors were administered. This group served as the reference for comparison of hemodynamic and clinical outcomes.

Norepinephrine Plus Vasopressin

Participants with septic shock who received adjunctive vasopressin in addition to norepinephrine. Vasopressin was initiated during the course of vasodilatory shock based on clinical judgment. The study evaluated hemodynamic response and mortality in this group compared to norepinephrine monotherapy.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Critically ill adult patients with septic shock admitted to the intensive care unit of a tertiary academic hospital in Türkiye. All participants received norepinephrine as a first-line vasopressor, and a subset received adjunctive vasopressin.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karadeniz Technical University, Faculty of Medicine

Trabzon, 61080, Turkey (Türkiye)

Location

Related Publications (1)

  • Kucuk AO, Hocek AB, Aydin D, Acar B, Pehlivanlar E, Pehlivanlar Kucuk M. Exploring vasopressin use in septic shock: a retrospective cohort study from Turkiye (VASCO-TURK). BMC Anesthesiol. 2025 Nov 22;25(1):623. doi: 10.1186/s12871-025-03519-8.

MeSH Terms

Conditions

Shock, SepticCritical IllnessDiabetes Insipidus

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockDisease AttributesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPituitary DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Intensivist, Assistant Professor

Study Record Dates

First Submitted

April 17, 2025

First Posted

May 1, 2025

Study Start

January 1, 2024

Primary Completion

December 15, 2024

Study Completion

January 15, 2025

Last Updated

May 1, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

The dataset includes identifiable patient-level clinical data from a retrospective ICU cohort. Due to ethical and privacy considerations, individual participant data (IPD) will not be shared.

Locations