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CompletedNCT07658014DIAL-SEPSISUpdated Jun 18, 2026

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

An observational study in Sepsis, Vasoplegia and Septic Shock, sponsored by Hospital H+ Queretaro. Completed at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-18.

Sponsored by Hospital H+ Queretaro · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
526
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Sepsis
  • Vasoplegia
  • Septic Shock

Keywords

  • Sepsis
  • vasoplegia
  • Diastolic Shock Index
  • Lactate
  • Norepinephrine.
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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.
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
526 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

05

What researchers measure

Primary outcomes

  1. Initiation of norepinephrine (vasopressor).

    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.

    Time frame: Within the first 6 hours of ICU admission.

06

Study locations

1 site
  • Hospital H+
    Querétaro City, Querétaro 7600, Mexico
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07658014
Lead sponsor
Hospital H+ Queretaro
Responsible party
Jose J Zaragoza, MD MSc (Amy Sevilla, Hospital H+ Queretaro) — Principal investigator
First posted
Jun 18, 2026
Start date
Jan 1, 2024
Primary completion
Apr 1, 2026
Completion
Apr 1, 2026
Last update
Jun 18, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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