Patients with septic shock who remain without reaching the hemodynamic goal of TAM> 65 mmHg, despite volume replacement and administration of noradrenaline at doses equal to or greater than 0.2 µg / Kg / min. MedDRA version: 23.1 Level: PT Classification code 10040070 Term: Septic shock System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0 Level: LLT Classification code 10040089 Term: Septicemia System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: GLYPRESSIN
Pharmaceutical Form: Injection
INN or Proposed INN: Terlipressin
CAS Number: 914453-96-6
Other descriptive name: analogue of vasopressin
Concentration unit: mg/h milligram(s)/ho
Sponsors
Fundación Pública Andaluza para la Gestión de la
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patients (18 years or older). 2. Patients with septic shock. 3. Patients with a SOFA index> 4 points. 4. Venous oxygen saturation (SvO2)> 70% 5. Central venous pressure (CVP)> 8 mmHg. 6. Signature of the informed consent by the patient or his or her legal representative. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 114 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 38
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating patients. 2. Pathologies on which terlipressin is clinically indicated: gastrointestinal bleeding due to esophageal-gastric varices, hepatorenal syndrome. 3. Patients diagnosed with unstable acute coronary syndrome. 4. Patients with acute or chronic mesenteric ischemia. 5. Patients with Raynaud's Phenomenon, or vasospastic disease. 6. Patients participating in another intervention clinical trial. 7. Patients with active bleeding. 8. Patients with renal replacement technique at the time of randomization. 9. Patients with some limitation of life support treatment (LLST). 10. Previous use of terlipressin during your stay in the ICU.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective is composed by: -Reduction of organ failure evaluated by Sepsis realted Organ failure Assessment score (SOFA scale) 72 h after administration of terlipressin / placebo. -Increase in ICU-free days of life measured 28 days after administration of terlipressin / placebo;Secondary Objective: -Increase in lactate clearance at 6, 12, 24 and 72 h after administration of terlipressin / placebo -Increase in the days with life free of mechanical ventilation measured at 28 days -Increase in vasopressor-free days of life measured at 28 days -Mortality at 28 days and 90 days -Reduction of the need for continuous renal replacement therapy -Reduction of the total equivalent dose of vasopressors -No increase in adverse effects related to the administration of vasopressors. -Association with mortality of genetic variants of the vasopressin receptor 1a and LNPEP. -Association between achievement of the combined primary objective and genetic variants of the vasopressin receptor 1a and LNPEP. -Association between the appearance of adverse effects due to the use of terlipressin and genetic variants of the vasopressin receptor 1a and LNPEP.;Primary end point(s): -Reduction of organ failure evaluated by SOFA scale -Increase in ICU-free days of life.;Timepoint(s) of evaluation of this end point: -Reduction of organ failure evaluated by SOFA scale 72 hours after administration of terlipressin / placebo. -Increase in ICU-free days of life measured 28 days after administration of terlipressin / placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: -Increase in lactate clearance at 6, 24 and 72 hours after administration of terlipressin / placebo. -Increase in the days of life free of mechanical ventilation measured at 28 days. -Increase in vasopressor-free days of life measured at 28 days. -Mortality at 28 days and 90 days.;Secondary end point(s): -Increase in lactate clearance. -Increase of the days with life free of mechanical ventilation. -Increase in vasopressor-free days of lif. -Mortality. -Reduction of the need for continuous renal replacement therapy (CRRT). -Reduction of the total equivalent dose of vasopressors. -No increase in adverse effects related to the administration of vasopressors. -Association of mortality with genetic variants of the vasopressin 1a receptor and the LNPEP gene. -Association between the achievement of the combined primary endpoint and the genetic variants of the vasopressin receptor 1a and the LNPEP gene. -Association between the appearance of adverse effects due to the use of terlipressin, and the genetic variants of the Vasopressin 1a receptor and LNPEP gene. | — |
Countries
Spain
Contacts
Public ContactUICEC-HUVR
Unidad de Investigación Clínica y ensayos Clínicos
Outcome results
None listed