Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
146 participants
OBSERVATIONAL
2024-01-01
2025-01-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Renal Outcomes in the Early Use of Vasopressin in the Treatment of Septic Shock
NCT06471231
Use of Vassopresin in Septic Shock Prospective Multicenter Observational Study With Medication
NCT07255378
Hypotension in the Weaning From Vasopressor Drugs
NCT05506319
Norepinephrine / Vasopressin Combination for Resuscitation in Septic Shock
NCT04302584
Comparison of Vasopressin and Other Pressors in Septic Shock
NCT00269685
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Karadeniz Technical University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
A. Oguzhan KUCUK
Intensivist, Assistant Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Karadeniz Technical University, Faculty of Medicine
Trabzon, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2025-5
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.