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

• Conditions: circulatory shock; Circulatory failure in sepsis; 10019815

• Registration Number: NL-OMON51438
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

Adult patients (>= 18 years) with septic shock according to Sepsis-3 consensus
conference. Septic shock is defined as suspected or confirmed infection, the
presence of increased lactate levels and the requirements for the
administration of a vasopressor to maintain blood pressure following a fluid
load of at least 1000mL in 1h.

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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The hierarchical composite of all-cause mortality within 28 days, time to<br /><br>cessation of vital support (truncated at 28 days) and length of hospital stay<br /><br>(truncated at 28 days). </p><br>