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Early Goal Directed Therapy Using a Physiological Holistic View. The ANDROMEDA-SHOCK Study

NCT03078712 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 424

Last updated 2018-07-23

No results posted yet for this study

Summary

Septic shock is a highly lethal condition associated with a mortality risk of 30 to 60%. Optimizing tissue perfusion and oxygenation is the aim to decrease mortality and morbidity in septic shock patients.

Persistent hyperlactatemia after initial resuscitation is particularly difficult to interpret, although optimizing systemic blood flow might reverse ongoing hypoperfusion. Nevertheless, if persistent hyperlactatemia is caused by non-hypoperfusion-related mechanisms, then sustained efforts aimed at increasing cardiac output (CO) could lead to detrimental effects of excessive fluids or inotropes. Another potential alternative resuscitation target is peripheral perfusion as assessed by capillary refill time (CRT), mottling score or central-to-toe temperature differences. Reversal of abnormal peripheral perfusion might represent improvement in tissue hypoperfusion with the advantage of a faster recovery than lactate.

Hypothesis: Peripheral perfusion guided resuscitation in septic shock is associated with lower mortality, less organ dysfunctions, less mechanical ventilation (MV), less vasopressor load, and less renal replacement therapies than a lactate-targeted resuscitation strategy.

Main Objective To test if peripheral perfusion targeted resuscitation in septic shock is associated with lower 28-day mortality than a lactate targeted resuscitation.

Design: Multicenter, Parallel Assignment randomized controlled study, conducted under supervision of an independent Data Safety Monitoring Board (DSMB).

Interventions:

1. Active Comparator- Peripheral Perfusion guided resuscitation
2. Active Comparator- Lactate guided resuscitation

Randomization: 1:1 the randomization using a block size of eight will be stratified according to participating centers.

Trial size: 400 randomized patients in 30 ICUs.

Conditions

  • Septic Shock
  • Hyperlactatemia
  • Peripheral Perfusion

Interventions

OTHER

Peripheral Perfusion guided resuscitation

Sequential approach with fluids (guided by dynamic predictors of fluid responsiveness), vasopressors titration, and inodilators according to peripheral perfusion.

OTHER

Lactate guided resuscitation

Sequential approach with fluids (guided by dynamic predictors of fluid responsiveness), vasopressors titration, and inodilators according to lactate decrease.

Sponsors & Collaborators

  • Pontificia Universidad Catolica de Chile

    lead OTHER

Principal Investigators

  • Glenn Hernandez, PhD · Pontificia Universidad Catolica de Chile

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2018-03-15
Completion
2018-06-30

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03078712 on ClinicalTrials.gov