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Clinical trial of early septic shock resuscitation based on hemodynamic phenotypes and guided by capillary refill time.

THERE ARE 4 RELEVANT ACTIONS THAT COULD INCREASE THE EFFICACY OF THE ANDROMEDA-SHOCK-2 STRATEGY TO REDUCE MORTALITY AND ORGAN DYSFUNCTION: USE OF CRT AS A GOAL, CLINICAL HEMODYNAMIC PHENOTYPING, SYSTEMATIC AND REPEATED ASSESSMENT OF FLUID RESPONSIVENESS, AND THE USE OF ECHOCARDIOGRAPHY IN INTENSIVE CARE. IN THIS STUDY, ALL OF THEM WILL BE PERFORMED TO IMPROVE RESUSCITATION IN PATIENTS WITH SEPTIC SHOCK. THE PREVIOUSLY DEVELOPED ANDROMEDA-SHOCK CLINICAL STUDY DEMONSTRATED THAT STOPPING RESUSCITATION WHEN A SIMPLE CLINICAL SIGN CALLED "CAPILLARY REFILL TIME" IS NORMALIZED IS ASSOCIATED WITH A SIGNIFICANT DECREASE IN MORTALITY, AS PATIENTS ARE LESS EXPOSED TO EXCESS INTRAVENOUS FLUIDS. CAPILLARY REFILL TIME" REFERS TO THE TIME MEASURED IN SECONDS IT TAKES FOR THE TIP OF THE INDEX FINGER TO RETURN TO ITS NORMAL COLOR AFTER CONSTANT PRESSURE ON IT FOR 10 SECONDS. CAPILLARY REFILL TIME IS MEASURED ONLY BY TOUCHING THE PATIENT'S HANDS, AND ITS NORMALIZATION REFLECTS THAT OXYGENATED BLOOD HAS REACHED THE ENTIRE BODY. THE PURPOSE OF THE PRESENT STUDY IS TO EVALUATE, IN A LARGER NUMBER OF PATIENTS, WHETHER THIS SEPTIC SHOCK RESUSCITATION STRATEGY -COMPARED TO STANDARD PRACTICE- DECREASES MORTALITY FROM SEPTIC SHOCK.

Status
In recruitment
headquarters
Pamplona

Technical Summary

  • EARLY SEPTIC SHOCK RESUSCITATION BASED ON HEMODYNAMIC PHENOTYPES AND GUIDED BY CAPILLARY REFILL TIME (ANDROMEDA-SHOCK-2): A RANDOMIZED, OPEN-LABEL, MULTICENTER, CLINICAL TRIAL.
  • Code EudraCT: 2021-005358-28
  • Protocol number: ANDROMEDA-SHOCK-2
  • Promoter: Pontificia Universidad Católica de Chile

* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.

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