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Recruiting NCT07255378

NCT07255378 Use of Vassopresin in Septic Shock Prospective Multicenter Observational Study With Medication

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Clinical Trial Summary
NCT ID NCT07255378
Status Recruiting
Phase
Sponsor Jamil Cedeño Mora
Condition Septic Shock
Study Type OBSERVATIONAL
Enrollment 1,200 participants
Start Date 2025-10-01
Primary Completion 2027-10-31

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type OBSERVATIONAL
Interventions
Usage of vasopressin (VAP) as a second-line vasopressor in septic shock patients.

Eligibility Fast-Check

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 1,200 participants in total. It began in 2025-10-01 with a primary completion date of 2027-10-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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.

Eligibility Criteria

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.

Contact & Investigator

Central Contact

Jamil Antonio Cedeño Mora

✉ jamilantonio.cedeno@salud.madrid.org

📞 +34 630 03 65 02

Frequently Asked Questions

Who can join the NCT07255378 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Septic Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07255378 currently recruiting?

Yes, NCT07255378 is actively recruiting participants. Contact the research team at jamilantonio.cedeno@salud.madrid.org for enrollment information.

Where is the NCT07255378 trial being conducted?

This trial is being conducted at Terrassa, Spain, Getafe, Spain, Madrid, Spain, Madrid, Spain and 8 additional locations.

Who is sponsoring the NCT07255378 clinical trial?

NCT07255378 is sponsored by Jamil Cedeño Mora. The trial plans to enroll 1,200 participants.

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