SepsisDIAL-SEPSISNCT07658014
Occult Vasoplegia in Normotensive Sepsis: Early Prediction With Diastolic Index and Lactate
An observational study of Sepsis and Vasoplegia, run by Hospital H+ Queretaro at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Vasoplegia, Septic Shock
- How many people
- 526 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jan 2024to 1 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Sepsis, Vasoplegia, Septic Shock
- Keywords
- Sepsis, vasoplegia, Diastolic Shock Index, Lactate, Norepinephrine.
- Medical subject headings
- Sepsis, Vasoplegia, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within the first 6 hours of ICU admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start1 Jan 2024
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 526 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital H+ Queretaro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose J Zaragoza, MD MSc, Hospital H+ Queretaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07658014
- Sponsor's protocol ID
- CEI2026-04/01/V1
- Acronym
- DIAL-SEPSIS
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Diastolic Shock Index and Lactate as Predictors of Occult Vasoplegia in Normotensive Sepsis.
- ClinicalTrials.gov ID
- NCT07658014
- Acronym / sponsor ID
- DIAL-SEPSIS / CEI2026-04/01/V1
- Conditions
- Sepsis, Vasoplegia, Septic Shock
- Keywords
- Sepsis, vasoplegia, Diastolic Shock Index, Lactate, Norepinephrine.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 526 participants (actual)
- Lead sponsor
- Hospital H+ QueretaroUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Vasoplegia, run by Hospital H+ Queretaro at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initiation of norepinephrine (vasopressor). (time frame: Within the first 6 hours of ICU admission.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.