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| Name | Class |
|---|---|
| Fundación para la Investigación Biomédica del Hospital Gregorio Maranon | OTHER |
| Hospital General Universitario Gregorio Marañon | OTHER |
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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:
Participants will:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Prognostic impact, in terms of all-cause mortality, of early VAP initiation in patients with septic shock. | From patient ICU-admission to 30 days after or patient ICU-discharge. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Eligible patients for this study must comply with the following requirements.
For the purposes of this study, septic shock is defined by full compliance with the following criteria.
Patients with some of the following conditions will be automatically excluded.
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ICU-admitted patients treated at Spanish public hospitals participating in the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jamil Antonio Cedeño Mora | Contact | +34 630 03 65 02 | jamilantonio.cedeno@salud.madrid.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Consorci Sanitari de Terrassa | Recruiting | Terrassa | BARCELONA | 08227 | Spain |
The study protocol agreed upon with the supervising authorities explicitly excludes the possibility of doing so.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 5, 2025 |
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| 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. | From patient ICU-admission to 30 days after or patient ICU-discharge. |
| Hospital Universitario de Getafe | Recruiting | Getafe | Madrid | 28905 | Spain |
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| Hospital Universitario La Princesa | Recruiting | Madrid | Madrid | 28006 | Spain |
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| Hospital General Universitario Gregorio Marañón | Recruiting | Madrid | Madrid | 28007 | Spain |
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| Hospital Universitario Ramón y Cajal | Recruiting | Madrid | Madrid | 28034 | Spain |
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| Hospital Universitario Clínico San Carlos | Recruiting | Madrid | Madrid | 28040 | Spain |
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| Hospital Universitario Doce de Octubre | Recruiting | Madrid | Madrid | 28041 | Spain |
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| Hospital Universitario La Paz | Recruiting | Madrid | Madrid | 28046 | Spain |
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| Hospital Universitario Puerta de Hierro | Recruiting | Majadahonda | Madrid | 28222 | Spain |
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| Hospital Universitario Rey Juan Carlos | Recruiting | Móstoles | Madrid | 28933 | Spain |
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| Hospital Universitario y Politécnico de La Fe | Recruiting | Valencia | Valencia | 46026 | Spain |
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| Hospital Universitario Miguel Servet | Recruiting | Zaragoza | ZARAGOZA | 50009 | Spain |
|
| Dec 7, 2025 |
| Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
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