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

NCT07658014 | Completed

• 1 other identifier: CEI2026-04/01/V1
• Study Type: observational
• Target: 526
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Vasoplegia; Septic Shock

Keywords

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

Outcome Measures

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.

  Within the first 6 hours of ICU admission.

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital H+ Queretaro: lead

Study Sites (1)

Hospital H+

Querétaro City, Querétaro, 7600, Mexico

Location

MeSH Terms

Conditions

Sepsis; Vasoplegia; Shock, Septic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Amy Sevilla

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 18, 2026
• Study Start: January 1, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: June 18, 2026

Record last verified: 2026-06

Locations

ME (1)