Use of Vassopresin in Septic Shock Prospective Multicenter Observational Study With Medication (NCT07255378) | Clinical Trial Compass
RecruitingNot Applicable
Use of Vassopresin in Septic Shock Prospective Multicenter Observational Study With Medication
Spain1,200 participantsStarted 2025-10-01
Plain-language 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.
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Prognostic impact, in terms of all-cause mortality, of early VAP initiation in patients with septic shock.
Timeframe: From patient ICU-admission to 30 days after or patient ICU-discharge.