Assessing blood flow changes in septic shock patients using advanced imaging
Improving the Assessment of Microcirculatory Dysfunction in Septic Shock Patients Using Optical Coherence Tomography Angiography at the Bedside
This study is testing how blood flow changes in the eyes of patients with septic shock to see if it can help predict their risk of organ failure and death.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 165 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital da Luz, Portugal Academic / other |
| Locations | 1 site (Lisboa) |
| Trial ID | NCT04593212 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate microcirculatory dysfunction in patients experiencing septic shock by utilizing optical coherence tomography angiography (OCTA). The primary objective is to characterize alterations in retinal and choroidal microcirculation, focusing on parameters such as vascular density and blood flow index. Additionally, the study seeks to determine the prognostic value of these microcirculatory changes in predicting organ failure and mortality. The research will involve two sequential observational studies to gather comprehensive data on these aspects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been diagnosed with septic shock within the last 24 hours.
Not a fit: Patients with shock due to causes other than septic shock or those with pre-existing eye conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prognostic assessments and treatment strategies for patients with septic shock.
How similar studies have performed: While the use of OCTA in this context is relatively novel, similar studies have shown promise in assessing microcirculatory dysfunction in other conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥ 18 years-old * septic shock diagnosis (defined by the presence of sepsis according to Sepsis-3 definition plus a SOFA score ≥ 3 points at cardiovascular system despite adequate volume resuscitation) less than 24 hours before the first OCTA assessment Exclusion Criteria: * Inability or willingness to provide informed consent from the patient or next of kin * Shock due to any other cause without septic shock * Bilateral eye absence * Previously known retinopathy * Previous retinal surgery or photocoagulation * Pregnant women * Participants with psychiatry disorders
Where this trial is running
Lisboa
- Hospital da Luz Lisboa — Lisboa, Portugal (Recruiting)
Study contacts
- Principal investigator: André Alexandre, MD — 11170
- Study coordinator: André Alexandre, MD
- Email: andre.alexandre@hospitaldaluz.pt
- Phone: 351217104400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.