Occult Vasoplegia in Normotensive Sepsis: Early Prediction With Diastolic Index and Lactate

Initial Diastolic Shock Index and Lactate as Predictors of Occult Vasoplegia in Normotensive Sepsis.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07658014

Acronym

DIAL-SEPSIS

Enrollment

526

Registered

2026-06-18

Start date

2024-01-01

Completion date

2026-04-01

Last updated

2026-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis, Septic Shock, Vasoplegia

Keywords

Sepsis, vasoplegia, Diastolic Shock Index, Lactate, Norepinephrine.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Initiation of norepinephrine (vasopressor).	Within the first 6 hours of ICU admission.	Predictive accuracy, measured by the Area Under the ROC Curve (AUC-ROC), of the initial Diastolic Shock Index (DSI), initial Lactate, and their combination to predict the requirement for norepinephrine. A cutoff point will be defined using the Youden index.

Countries

Mexico

Outcome results