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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03078712 |
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Date of registration:
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06/03/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Early Goal Directed Therapy Using a Physiological Holistic View. The ANDROMEDA-SHOCK Study
ANDROMEDA |
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Scientific title:
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Early Goal Directed Therapy Using a Physiological Holistic View. A Multicenter Study in Latin America: The ANDROMEDA-SHOCK Study |
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Date of first enrolment:
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March 1, 2017 |
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Target sample size:
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424 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03078712 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Chile
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Contacts
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Name:
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Glenn Hernandez, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pontificia Universidad Catolica de Chile |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hyperlactatemia
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Peripheral Perfusion
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Septic Shock
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Intervention(s)
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Other: Lactate guided resuscitation
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Other: Peripheral Perfusion guided resuscitation
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Primary Outcome(s)
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All-cause of mortality
[Time Frame: 28 days]
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Secondary Outcome(s)
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Need of mechanical ventilation
[Time Frame: 28 days]
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Variations in Sequential Organ failure Assessment (SOFA)
[Time Frame: At 8, 24, 48 and 72 hours]
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Need of renal replacement therapies (RRT)
[Time Frame: 28 days]
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Days free of MV, vasopressors and RRT
[Time Frame: 28 days]
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Secondary ID(s)
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161130002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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