Septic ShockVASO-2024NCT07255378
Use of Vassopresin in Septic Shock Prospective Multicenter Observational Study With Medication
An observational study of Septic Shock, run by Jamil Cedeño Mora at 12 sites in Spain.
Trial summary
The aim of this observational study is to examine real-world clinical practice regarding the use of vasopressin as a second-line vasopressor in adult patients admitted to Intensive Care Units (ICUs) with septic shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Usage of vasopressin (VAP) as a second-line vasopressor in septic shock patients.
- How many people
- 1,200 participants
- Where
- 12 sitesSpain
- Study dates
- 1 Oct 2025to 1 Jan 2028
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: ICU-admitted patients treated at Spanish public hospitals participating in the study.
Eligible patients for this study must comply with the following requirements.
- ICU admission with a septic shock diagnosis.
- Age 18 years or above at ICU admission.
- Use of vasopressin as an adjunct of norepinephrine.
For the purposes of this study, septic shock is defined by full compliance with the following criteria.
- Sustained arterial hypotension or serum lactate above 2 mmol/L.
- Adequate but unsuccessful fluid resuscitation.
- Vasopressor usage to maintain a mean arterial pressure above 65 mmHg.
- Probable or proven infectious etiology.
Patients with some of the following conditions will be automatically excluded.
- Pregnancy.
- Ischemic cardiogenic shock.
- Acute intestinal ischemia.
- Readmission to the Intensive Care Unit.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
Spain12 sites, 12 recruiting
- Recruiting
Hospital Universitario de Getafe
Getafe, Madrid, 28905
Oscar Peñuelas-Rodríguez, oscar.penuelasro@salud.madrid.org
- Recruiting
Hospital Universitario La Princesa
Madrid, Madrid, 28006
Belén Román-García, belen.roman@salud.madrid.org
- Recruiting
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, 28007
Galo Castañeda-Alvarado, +34 722 654 888, galofrancisco.castaneda@salud.madrid.org
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid, Madrid, 28034
Aarón Blandino-Ortiz, ablandinoortiz@gmail.com
- Recruiting
Hospital Universitario Clínico San Carlos
Madrid, Madrid, 28040
Fernando Martínez-Sagasti, fernando.martinez@salud.madrid.org
- Recruiting
Hospital Universitario Doce de Octubre
Madrid, Madrid, 28041
María Cruz Martín-Delgado, +34 637 76 41 84, mariacruz.martin@salud.madrid.org
- Recruiting
Hospital Universitario La Paz
Madrid, Madrid, 28046
Manuel Quintana-Díaz, +34 666 86 25 71, manuel.quintana@uam.es
- Recruiting
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222
Daniel Ballesteros-Ortega, daniel.ortega@salud.madrid.org
- Recruiting
Hospital Universitario Rey Juan Carlos
Móstoles, Madrid, 28933
Alberto Garrido-Callén, alberto.garrido@hospitalreyjuancarlos.es
- Recruiting
Consorci Sanitari de Terrassa
Terrassa, BARCELONA, 08227
Angélica Ramírez, gencarami@gmail.com
- Recruiting
Hospital Universitario y Politécnico de La Fe
Valencia, Valencia, 46026
Sergi Tormo-Ferrándiz, Tormo_ser@gva.es
- Recruiting
Hospital Universitario Miguel Servet
Zaragoza, ZARAGOZA, 50009
María Barrera-Sánchez, mbarrerasanchez96@gmail.com
About this study
Official title: Use of Vasopressin in Septic Shock.
The aim of this observational study is to examine real-world clinical practice regarding the use of vasopressin as a second-line vasopressor in adult patients admitted to Intensive Care Units (ICUs) with septic shock.
The study focuses on critically ill adults (≥18 years) diagnosed with septic shock and treated with norepinephrine and vasopressin.
Read more
The main research questions are:
- Does early initiation of vasopressin-defined by the norepinephrine dose at the time of introduction-reduce mortality in patients with septic shock?
- What is the impact of vasopressin as a second vasopressor on renal function and the progression of organ dysfunction in septic shock patients?
Participants will:
- Be admitted to an ICU with a diagnosis of septic shock.
- Receive vasopressin as an adjunct to norepinephrine for hemodynamic support.
- Be monitored daily throughout their ICU stay, with data collected through a dedicated REDCap system.
- Have relevant clinical data pseudonymized and incorporated into the study database for statistical analysis.
- Conditions
- Septic Shock
- Being tested
- Usage of vasopressin (VAP) as a second-line vasopressor in septic shock patients.
- Keywords
- Norepinephrine, Septic Shock, Dose Threshold, Intensive Care Unit, Arginine Vasopressin Initiation
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usage of vasopressin (VAP) as a second-line vasopressor in septic shock patients.Drug
A state-of-the-art line of research in septic shock management focuses on the potential use of a second vasopressor agent. Current efforts aim to determine which drug should be used and the optimal timing for its initiation. In line with this, the Surviving Sepsis Campaign 2021 clinical guide recommends considering vasopressin-arginine (VAP) as a second-line vasopressor when norepinephrine (NAD) doses exceed 0.25 µg/kg/min, although this suggestion is based on limited evidence and remains weak.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic impact, in terms of all-cause mortality, of early VAP initiation in patients with septic shock.
Measured: From patient ICU-admission to 30 days after or patient ICU-discharge.
Secondary outcomes (2)
Impact of vasopressin usage as a second vasopressor on renal function.
Renal function will be assessed using the Kidney Disease: Improving Global Outcomes (KDIGO) criteria for acute kidney injury (AKI). KDIGO stages range from 0 (no AKI) to 3 (severe AKI), with higher stages indicating worse renal function. KDIGO classification will be recorded at 24, 48, and 72 hours after vasopressin initiation, as well as the highest stage reached during the entire ICU stay.
In addition to KDIGO staging, the need for renal replacement therapy (RRT) during admission will also be recorded as an indicator of progression to kidney failure.
Measured: From patient ICU-admission to 30 days after or patient ICU-discharge.
Impact of VAP use as a second vasopressor on the progression of organ dysfunction.
Organ dysfunction will be measured using the Sequential Organ Failure Assessment (SOFA) score, which ranges from 0 (no organ dysfunction) to 24 (severe multi-organ failure). Higher scores indicate worse outcomes. SOFA score will be recorded at 24, 48, and 72 hours after vasopressin initiation, as well as the maximum SOFA score obtained during the ICU stay.
Measured: From patient ICU-admission to 30 days after or patient ICU-discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start1 Oct 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Jamil Cedeño Mora
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación para la Investigación Biomédica del Hospital Gregorio Maranon, Hospital General Universitario Gregorio Marañon
- Responsible party
- Sponsor-investigator, Jamil Cedeño Mora, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07255378
- Sponsor's protocol ID
- VASO-2024
- Acronym
- VASO-2024
- Status last verified
- Dec 2025
- First submitted
- 20 Nov 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The study protocol agreed upon with the supervising authorities explicitly excludes the possibility of doing so.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Vasopressin in Septic Shock.
- ClinicalTrials.gov ID
- NCT07255378
- Acronym / sponsor ID
- VASO-2024 / VASO-2024
- Conditions
- Septic Shock
- Keywords
- Norepinephrine, Septic Shock, Dose Threshold, Intensive Care Unit, Arginine Vasopressin Initiation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Jamil Cedeño MoraUniversity, hospital or other
- Collaborators
- Fundación para la Investigación Biomédica del Hospital Gregorio Maranon, Hospital General Universitario Gregorio Marañon
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 1 Dec 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 aim of this observational study is to examine real-world clinical practice regarding the use of vasopressin as a second-line vasopressor in adult patients admitted to Intensive Care Units (ICUs) with septic shock.
The study focuses on critically ill adults (≥18 years) diagnosed with septic shock and treated with norepinephrine and vasopressin.
The main research questions are:
- Does early initiation of vasopressin-defined by the norepinephrine dose at the time of introduction-reduce mortality in patients with septic shock?
- What is the impact of vasopressin as a second vasopressor on renal function and the progression of organ dysfunction in septic shock patients?
Participants will:
- Be admitted to an ICU with a diagnosis of septic shock.
- Receive vasopressin as an adjunct to norepinephrine for hemodynamic support.
- Be monitored daily throughout their ICU stay, with data collected through a dedicated REDCap system.
- Have relevant clinical data pseudonymized and incorporated into the study database for statistical analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU-admitted patients treated at Spanish public hospitals participating in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usage of vasopressin (VAP) as a second-line vasopressor in septic shock patients.A state-of-the-art line of research in septic shock management focuses on the potential use of a second vasopressor agent. Current efforts aim to determine which drug should be used and the optimal timing for its initiation. In line with this, the Surviving Sepsis Campaign 2021 clinical guide recommends considering vasopressin-arginine (VAP) as a second-line vasopressor when norepinephrine (NAD) doses exceed 0.25 µg/kg/min, although this suggestion is based on limited evidence and remains weak. | Drug | – |
Primary outcome
Prognostic impact, in terms of all-cause mortality, of early VAP initiation in patients with septic shock.
Time frame: From patient ICU-admission to 30 days after or patient ICU-discharge.
2 secondary outcomes
Impact of vasopressin usage as a second vasopressor on renal function.
Time frame: From patient ICU-admission to 30 days after or patient ICU-discharge.
Impact of VAP use as a second vasopressor on the progression of organ dysfunction.
Time frame: From patient ICU-admission to 30 days after or patient ICU-discharge.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: No. The study protocol agreed upon with the supervising authorities explicitly excludes the possibility of doing so.
Related trials for Septic Shock
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis
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.
12 sites 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, run by Jamil Cedeño Mora at 12 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jamil Antonio Cedeño Mora (+34 630 03 65 02, jamilantonio.cedeno@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognostic impact, in terms of all-cause mortality, of early VAP initiation in patients with septic shock. (time frame: From patient ICU-admission to 30 days after or patient ICU-discharge.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2025.