Occult Vasoplegia in Normotensive Sepsis: Early Prediction With Diastolic Index and Lactate (NCT07658014) | Clinical Trial Compass
CompletedNot Applicable
Occult Vasoplegia in Normotensive Sepsis: Early Prediction With Diastolic Index and Lactate
Mexico526 participantsStarted 2024-01-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study was looking at early warning signs of vasoplegia — a dangerous drop in blood vessel tone — in sepsis patients who still had normal blood pressure. If I'm being treated for sepsis right now, is my care team already monitoring the diastolic index and lactate levels that this study was investigating?
2The trial measured whether patients eventually needed norepinephrine, a vasopressor drug, as its main outcome — does that mean vasoplegia can develop even when blood pressure looks okay at first, and should I be asking about closer monitoring for that in my own case?
3Since this trial is already completed, has any of its data about early prediction of vasopressor need been published or shared, and could that information change how my team watches for deterioration in my condition?
4This study focused on 'occult' vasoplegia — meaning it may be hidden or not yet obvious — so how would my medical team know if I were developing this complication before my blood pressure actually drops, and what's the plan if that happens?
5Given that this was an observational study rather than a treatment trial, does it point toward any specific monitoring approach or clinical tools that my care team might consider using for my sepsis management?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Initiation of norepinephrine (vasopressor).
Timeframe: Within the first 6 hours of ICU admission.