Septic Shock(VASCO-TURK)NCT06953297
Vasopressin Use in Septic Shock From Türkiye
An observational study of Septic Shock and Vasodilatory Shock, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Vasodilatory Shock, Critical Illness Sepsis, Severe
- How many people
- 146 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 15 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karadeniz Technical University, Faculty of Medicine
Trabzon, 61080
About this study
Official title: Exploring Vasopressin Use in Septic Shock: A Retrospective Cohort Study 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:
Read more
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.
Read the 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.
- Conditions
- Septic Shock, Vasodilatory Shock, Critical Illness Sepsis, Severe, Critical Illness, Intensive Care Medicine, Vasopressor Therapy
- Keywords
- Septic Shock, Vasopressin, Norepinephrine, Vasopressor Therapy, Hemodynamic Response, ICU, Critical Care, intensive care unit, Mortality, Lactate, Mean Arterial Pressure, Türkiye
- Medical subject headings
- Shock, Septic, Critical Illness, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 hours after vasopressor initiation
Secondary outcomes (3)
All-Cause Mortality
Vital status (alive or deceased) at day 28 after ICU admission will be collected from medical records to compare mortality between treatment groups.
Measured: Up to Day 28 after ICU admission
Change in Serum Lactate Levels
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.
Measured: 6 hours
Change in Norepinephrine Dose After Vasopressin Initiation
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.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start1 Jan 2024
- Primary completion15 Dec 2024
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A. Oguzhan KUCUK, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953297
- Sponsor's protocol ID
- 2025-5
- Acronym
- (VASCO-TURK)
- Status last verified
- Apr 2025
- First submitted
- 17 Apr 2025
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 41275079
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Vasopressin Use in Septic Shock: A Retrospective Cohort Study From Türkiye
- ClinicalTrials.gov ID
- NCT06953297
- Acronym / sponsor ID
- (VASCO-TURK) / 2025-5
- Conditions
- Septic Shock, Vasodilatory Shock, Critical Illness Sepsis, Severe, Critical Illness, Intensive Care Medicine, Vasopressor Therapy
- Keywords
- Septic Shock, Vasopressin, Norepinephrine, Vasopressor Therapy, Hemodynamic Response, ICU, Critical Care, intensive care unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
All-Cause Mortality
Time frame: Up to Day 28 after ICU admission
Change in Serum Lactate Levels
Time frame: 6 hours
Change in Norepinephrine Dose After Vasopressin Initiation
Time frame: 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Derived from this study: PubMed 41275079Kucuk 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock and Vasodilatory Shock, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mean Arterial Pressure (MAP) Within 24 Hours After Vasopressin Initiation (time frame: 6 hours after vasopressor initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06953297, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.