oradrenaline plus placebo vs noradrenaline plus terlipressin for the treatment of septic shock

Phase 1

• Conditions: 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: 23.1Level: PTClassification code 10040070Term: Septic shockSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0Level: LLTClassification code 10040089Term: SepticemiaSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2020-005756-37-ES
• Lead Sponsor: Fundación Pública Andaluza para la Gestión de la

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-27
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 152

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified