NCT07658014CompletedNot Applicable
Initial Diastolic Shock Index and Lactate as Predictors of Occult Vasoplegia in Normotensive Sepsis.
Hospital H+ Queretaro1 site in 1 country526 target enrollmentStarted: January 1, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 526
- Locations
- 1
Study Overview
Brief Summary
The goal of this observational study is to learn if the Diastolic Shock Index (DSI) and initial lactate can predict occult vasoplegia in adults with normotensive sepsis. Normotensive sepsis occurs in patients who have an apparently normal mean arterial pressure but may have impaired vascular tone.
The main questions it aims to answer are:
- Can an elevated DSI at admission predict the initiation of vasopressors (norepinephrine) within the first 6 hours of intensive care unit stay?
- How does the combination of initial DSI and lactate perform compared to each marker alone in predicting hemodynamic deterioration? Researchers will compare patients with an elevated DSI to those with a normal DSI to see if this index identifies those who will progress to circulatory shock.Since this is a retrospective cohort study using existing medical records, participants will not be asked to perform any tasks. Researchers will analyze anonymized data, such as heart rate, blood pressure, and lactate levels already recorded in the institutional database.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients over 18 years of age.
- •Diagnosis of sepsis upon admission according to Sepsis-3 criteria (suspected or confirmed infection plus an increase in SOFA score >2).
- •Mean Arterial Pressure (MAP) during the first hour >=65 mmHg.
- •No vasopressor infusion at the time of initial assessment (Time 0)
Exclusion Criteria
- •Patients who died within the first 24 hours of admission.
- •Patients transferred out of the unit within the first 24 hours
- •Patients who were already receiving vasopressor support in the pre-hospital setting or the emergency department before ICU admission.
Investigators
Jose J Zaragoza, MD MSc
Amy Sevilla
Hospital H+ Queretaro
Study Sites (1)
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