Early Goal Directed Therapy Using a Physiological Holistic View. The ANDROMEDA-SHOCK Study (ANDROMEDA)
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|ClinicalTrials.gov Identifier: NCT03078712|
Recruitment Status : Completed
First Posted : March 13, 2017
Last Update Posted : July 23, 2018
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).
- Active Comparator- Peripheral Perfusion guided resuscitation
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Septic Shock Hyperlactatemia Peripheral Perfusion||Other: Peripheral Perfusion guided resuscitation Other: Lactate guided resuscitation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||424 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Early Goal Directed Therapy Using a Physiological Holistic View. A Multicenter Study in Latin America: The ANDROMEDA-SHOCK Study|
|Actual Study Start Date :||March 1, 2017|
|Actual Primary Completion Date :||March 15, 2018|
|Actual Study Completion Date :||June 30, 2018|
Active Comparator: Peripheral Perfusion guided resuscitation
Resuscitation will be aimed at normalization of capillary refill time.
Other: Peripheral Perfusion guided resuscitation
Sequential approach with fluids (guided by dynamic predictors of fluid responsiveness), vasopressors titration, and inodilators according to peripheral perfusion.
Active Comparator: Lactate guided resuscitation
Resuscitation will be aimed at normalization or significant decrease in lactate levels.
Other: Lactate guided resuscitation
Sequential approach with fluids (guided by dynamic predictors of fluid responsiveness), vasopressors titration, and inodilators according to lactate decrease.
- All-cause of mortality [ Time Frame: 28 days ]All cause of mortality.
- Need of mechanical ventilation [ Time Frame: 28 days ]Requirement of mechanical ventilation
- Need of renal replacement therapies (RRT) [ Time Frame: 28 days ]Requirement of renal replacement therapie
- Days free of MV, vasopressors and RRT [ Time Frame: 28 days ]Difference between hospital length of stay and days on which the patients receive MV, vasopressors and RRT
- Variations in Sequential Organ failure Assessment (SOFA) [ Time Frame: At 8, 24, 48 and 72 hours ]Differences in SOFA score between baseline and different time-points.
- Acute kidney injury (AKI) [ Time Frame: 28 days ]Fulfilment of AKI criteria.
- Intra-abdominal hypertension [ Time Frame: 28 days ]Fulfilment of Intra-abdominal hypertension criteria.
- Fluid balances [ Time Frame: At 8, 24, 48 and 72 hours ]Fluid balances at different time-points.
- All-cause of hospital mortality [ Time Frame: 90 days ]All-cause of hospital mortality.
- Intensive care unit (ICU) and hospital length of stay [ Time Frame: Through study completion, an average of 1 year ]Days on which the patients stayed in the ICU and the hospital
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03078712
|Pontificia Universidad Católica de Chile|
|Santiago, Metropolitana, Chile, 7500000|
|Principal Investigator:||Glenn Hernandez, PhD||Pontificia Universidad Catolica de Chile|