Status:
UNKNOWN
Clinical Trial Comparing Noradrenaline (NA) Plus Placebo Versus Noradrenaline Plus Terlipressin (TP) in Septic Shock
Lead Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Conditions:
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Septic shock is a major health problem. In the clinical practice guidelines of the Surviving Sepsis Campaign is recommended to add vasopressin (VP) or epinephrine in case of not reaching the goal of m...
Detailed Description
Introduction: Septic shock is a major health problem. The clinical practice guidelines of the Surviving Sepsis Campaign establish the use of NE if after resuscitation with fluids a MAP\> 65 mm Hg is n...
Eligibility Criteria
Inclusion
- Adult patients (18 years or older).
- Patients with septic shock
- Patients with a SOFA \> 4 points.
- 5\. Oxygen saturation in the central venous system \> 70% 5. Central venous pressure\> 8 mmHg. 6. Signature of the informed consent by the patient or her legal representative.
Exclusion
- Pregnant or lactating patients.
- Pathologies in which terlipressin is clinically indicated: gastrointestinal bleeding due to esophageal-gastric varices, hepatorenal syndrome.
- Patients diagnosed with unstable acute coronary syndrome.
- Patients with acute or chronic mesenteric ischemia.
- Patients with Raynaud's Phenomenon, or vasospastic disease.
- Patients participating in another intervention clinical trial.
- Patients with active bleeding.
- Patients with renal replacement technique at the time of randomization.
- Patients with some limitation of life support treatment
- Previous use of terlipressin during your stay in the intensive Care Unit
Key Trial Info
Start Date :
October 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2024
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT05207280
Start Date
October 11 2022
End Date
November 1 2024
Last Update
April 27 2023
Active Locations (10)
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1
Hospital Universitario Jerez de la Frontera
Jerez de la Frontera, Cádiz, Spain, 11407
2
Hospital San Juan de Dios del Aljarafe
Bormujos, Sevilla, Spain, 41930
3
Hospital Puerta del mar
Cadiz, Spain, 11009
4
Hospital Universitario Reina Sofía
Córdoba, Spain, 14004