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

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.

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Key information

Conditions

Sepsis Cardiovascular Diseases Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome Vascular Diseases Vasoplegia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital H+

Querétaro City, Querétaro, 7600, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Initiation of norepinephrine (vasopressor).

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospital H+ Queretaro

Other

Registry information

Official study title

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

Acronym: DIAL-SEPSIS

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Jun 18, 2026
Registry last updated: Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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