Occult Vasoplegia in Normotensive Sepsis: Early Prediction With Diastolic Index and Lactate (DIAL-SEPSIS)

June 15, 2026 updated by: Jose J Zaragoza, MD MSc, Hospital H+ Queretaro

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

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

526

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Querétaro
      • Querétaro City, Querétaro, Mexico, 7600
        • Hospital H+

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of adult patients admitted to the Intensive Care Unit (ICU) of Hospital H+ Querétaro. The cohort includes individuals with a diagnosis of sepsis (Sepsis-3) who maintain a mean arterial pressure (MAP) >=65 mmHg without the need for vasopressors during their initial hour of admission. These patients are identified from an existing institutional database covering the period between January 1, 2024, and May 31, 2025. The population represents a specific group of critically ill patients who, despite appearing hemodynamically stable (normotensive), are at risk of rapid progression to overt circulatory collapse and vasoplegia.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Elevated Diastolic Shock Index (DSI)
Adult patients (>=18 years) admitted to the ICU with a diagnosis of sepsis (Sepsis-3 criteria) who are normotensive upon arrival (MAP >= 65 mmHg) and not yet receiving vasopressor support, but who present with a Diastolic Shock Index above the optimal cutoff point determined during analysis.
Normal Diastolic Shock Index (DSI)
Adult patients (>=18 years) admitted to the ICU with a diagnosis of sepsis (Sepsis-3 criteria) who are normotensive upon arrival (MAP >= 65 mmHg) and not receiving vasopressor support, with a Diastolic Shock Index and lactate levels within normal ranges.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within the first 6 hours of ICU admission.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital H+ Queretaro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

April 1, 2026

Study Completion (Actual)

April 1, 2026

Study Registration Dates

First Submitted

June 15, 2026

First Submitted That Met QC Criteria

June 15, 2026

First Posted (Actual)

June 18, 2026

Study Record Updates

Last Update Posted (Actual)

June 18, 2026

Last Update Submitted That Met QC Criteria

June 15, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEI2026-04/01/V1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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