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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03078712
Recruitment Status : Completed
First Posted : March 13, 2017
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
Glenn Hernández, Pontificia Universidad Catolica de Chile

Brief 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.


Condition or disease Intervention/treatment Phase
Septic Shock Hyperlactatemia Peripheral Perfusion Other: Peripheral Perfusion guided resuscitation Other: Lactate guided resuscitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 424 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. All-cause of mortality [ Time Frame: 28 days ]
    All cause of mortality.


Secondary Outcome Measures :
  1. Need of mechanical ventilation [ Time Frame: 28 days ]
    Requirement of mechanical ventilation

  2. Need of renal replacement therapies (RRT) [ Time Frame: 28 days ]
    Requirement of renal replacement therapie

  3. 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

  4. 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.


Other Outcome Measures:
  1. Acute kidney injury (AKI) [ Time Frame: 28 days ]
    Fulfilment of AKI criteria.

  2. Intra-abdominal hypertension [ Time Frame: 28 days ]
    Fulfilment of Intra-abdominal hypertension criteria.

  3. Fluid balances [ Time Frame: At 8, 24, 48 and 72 hours ]
    Fluid balances at different time-points.

  4. All-cause of hospital mortality [ Time Frame: 90 days ]
    All-cause of hospital mortality.

  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Septic shock diagnosed at ICU admission according to the Sepsis-3 Consensus Conference, (basically septic patients with hypotension requiring norepinephrine (NE) to maintain a mean arterial pressure (MAP) of ≥ 65 mmHg, and serum lactate levels > 2 mmol/l after initial fluid resuscitation with at least 20/ml kg in one hour.

Exclusion Criteria:

  • Pregnancy
  • Anticipated surgery or dialysis procedure during the first 8h after septic shock diagnosis
  • Do-not-resuscitate status
  • Child B or C liver cirrhosis
  • Active bleeding
  • Acute hematological malignancy
  • Severe concomitant acute respiratory distress syndrome (ARDS)
  • More than 4h after officially meeting septic shock criteria

Information from the National Library of Medicine

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


Locations
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Chile
Pontificia Universidad Católica de Chile
Santiago, Metropolitana, Chile, 7500000
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Investigators
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Principal Investigator: Glenn Hernandez, PhD Pontificia Universidad Catolica de Chile
  Study Documents (Full-Text)

Documents provided by Glenn Hernández, Pontificia Universidad Catolica de Chile:
Study Protocol  [PDF] April 23, 2018
Statistical Analysis Plan  [PDF] May 11, 2018


Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Hernández G, Ospina-Tascón GA, Damiani LP, Estenssoro E, Dubin A, Hurtado J, Friedman G, Castro R, Alegría L, Teboul JL, Cecconi M, Ferri G, Jibaja M, Pairumani R, Fernández P, Barahona D, Granda-Luna V, Cavalcanti AB, Bakker J; The ANDROMEDA SHOCK Investigators and the Latin America Intensive Care Network (LIVEN), Hernández G, Ospina-Tascón G, Petri Damiani L, Estenssoro E, Dubin A, Hurtado J, Friedman G, Castro R, Alegría L, Teboul JL, Cecconi M, Cecconi M, Ferri G, Jibaja M, Pairumani R, Fernández P, Barahona D, Cavalcanti AB, Bakker J, Hernández G, Alegría L, Ferri G, Rodriguez N, Holger P, Soto N, Pozo M, Bakker J, Cook D, Vincent JL, Rhodes A, Kavanagh BP, Dellinger P, Rietdijk W, Carpio D, Pavéz N, Henriquez E, Bravo S, Valenzuela ED, Vera M, Dreyse J, Oviedo V, Cid MA, Larroulet M, Petruska E, Sarabia C, Gallardo D, Sanchez JE, González H, Arancibia JM, Muñoz A, Ramirez G, Aravena F, Aquevedo A, Zambrano F, Bozinovic M, Valle F, Ramirez M, Rossel V, Muñoz P, Ceballos C, Esveile C, Carmona C, Candia E, Mendoza D, Sanchez A, Ponce D, Ponce D, Lastra J, Nahuelpán B, Fasce F, Luengo C, Medel N, Cortés C, Campassi L, Rubatto P, Horna N, Furche M, Pendino JC, Bettini L, Lovesio C, González MC, Rodruguez J, Canales H, Caminos F, Galletti C, Minoldo E, Aramburu MJ, Olmos D, Nin N, Tenzi J, Quiroga C, Lacuesta P, Gaudín A, Pais R, Silvestre A, Olivera G, Rieppi G, Berrutti D, Ochoa M, Cobos P, Vintimilla F, Ramirez V, Tobar M, García F, Picoita F, Remache N, Granda V, Paredes F, Barzallo E, Garcés P, Guerrero F, Salazar S, Torres G, Tana C, Calahorrano J, Solis F, Torres P, Herrera L, Ornes A, Peréz V, Delgado G, López A, Espinosa E, Moreira J, Salcedo B, Villacres I, Suing J, Lopez M, Gomez L, Toctaquiza G, Cadena Zapata M, Orazabal MA, Pardo Espejo R, Jimenez J, Calderón A, Paredes G, Barberán JL, Moya T, Atehortua H, Sabogal R, Ortiz G, Lara A, Sanchez F, Hernán Portilla A, Dávila H, Mora JA, Calderón LE, Alvarez I, Escobar E, Bejarano A, Bustamante LA, Aldana JL. Effect of a Resuscitation Strategy Targeting Peripheral Perfusion Status vs Serum Lactate Levels on 28-Day Mortality Among Patients With Septic Shock: The ANDROMEDA-SHOCK Randomized Clinical Trial. JAMA. 2019 Feb 19;321(7):654-664. doi: 10.1001/jama.2019.0071.

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Responsible Party: Glenn Hernández, Tenured Professor, Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT03078712    
Other Study ID Numbers: 161130002
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Glenn Hernández, Pontificia Universidad Catolica de Chile:
Septic Shock
Lactate
Capillary Refill Time
Fluid Responsiveness
Mortality
Additional relevant MeSH terms:
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Shock, Septic
Hyperlactatemia
Shock
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Metabolic Diseases
Signs and Symptoms