Karadeniz Technical University, Faculty of Medicine
Trabzon, 61080, Turkey (Türkiye)
NCT Number: NCT06953297
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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All sexes
Observational
Trabzon, 61080, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
Karadeniz Technical University
Other
Exploring Vasopressin Use in Septic Shock: A Retrospective Cohort Study From Türkiye
Acronym: (VASCO-TURK)
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