Hemodynamic Phenotype-Based, Capillary Refill Time-Targeted Resuscitation In Early Septic Shock: The ANDROMEDA-SHOCK-2 Randomized Clinical Trial (A2)

Phase 1

• Conditions: Septic shock; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2021-005358-28-ES
• Lead Sponsor: Pontificia Universidad Católica de Chile

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-10
• Last Update Posted: 16 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

- Consecutive adult patients (= 18 years) with septic shock according to Sepsis-3 consensus conference. In short, septic shock is defined as suspected or confirmed infection, plus hyperlactatemia and NE requirements due to persistent hypotension, after a fluid load of at least 1000mL in 1h.
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 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

- More than 4 hours since septic shock diagnosis
- Anticipated surgery or acute hemodialysis procedure to start during the 6h intervention period
- Active bleeding
- Do not resuscitate status
- Child B-C Cirrhosis
- Underlying disease process with a life expectancy < 90 days and/or the attending clinician deems aggressive resuscitation unsuitable
- Refractory shock (high risk of death within 24h)
- Pregnancy
- Concomitant severe acute respiratory distress syndrome.
- Patients in whom CRT cannot be accurately assessed

Study & Design

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