Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06062303

Hemodynamic Phenotype-Based,Capillary Refill Time-Targeted Resuscitation In Early Septic Shock:ANDROMEDA-SHOCK-2

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-12-05

180

Participants Needed

1

Research Sites

120 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Over-resuscitation including fluid overload has been associated with increased morbidity (prolonged duration of organ failure) and mortality in septic shock. "One-size-fits-all" resuscitation strategies may increase septic shock mortality. However, clinical studies on individualized resuscitation are lacking. Hemodynamic phenotyping may allow to individualize septic shock resuscitation. The ANDROMEDA-SHOCK trial found that a simple clinical and bedside CRT-targeted resuscitation reduces organ dysfunction and 28-day mortality in septic shock. The current study will examine the hypothesis that a CRT-targeted resuscitation based on hemodynamic phenotyping considering within an decision tree usual bedside clinical parameters such as pulse pressure, diastolic blood pressure, fluid responsiveness and cardiac performance can further decrease mortality in septic shock as compared to usual care.

CONDITIONS

Official Title

Hemodynamic Phenotype-Based,Capillary Refill Time-Targeted Resuscitation In Early Septic Shock:ANDROMEDA-SHOCK-2

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients aged 18 years or older
  • Patients with septic shock defined by suspected or confirmed infection, high lactate levels, and norepinephrine use due to persistent low blood pressure after receiving at least 1000 mL of fluids within 1 hour
  • Patient or their relative has given informed consent to participate in the study
Not Eligible

You will not qualify if you...

  • More than 4 hours have passed since septic shock diagnosis
  • Planned surgery or acute hemodialysis during the 6-hour intervention period
  • Active bleeding
  • Do not resuscitate status
  • Child B or C cirrhosis
  • Life expectancy less than 90 days or clinician considers aggressive resuscitation unsuitable
  • Refractory shock with high risk of death within 24 hours
  • Pregnancy
  • Severe acute respiratory distress syndrome
  • Inability to accurately assess capillary refill time
  • No social security or social protection affiliation
  • Patient receiving state medical aid without exemption
  • Under legal guardianship or curatorship
  • Participation in another interventional study or within the exclusion period from a previous study
  • Inability to understand the study due to language or cognitive issues

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hôpital Robert Debré, Université de Reims

Reims, France, 51092

Actively Recruiting

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Research Team

O

Olfa MD Hamzaoui, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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