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Assessment of Microcirculatory Dysfunction in Septic Shock Patients by OCTA (SshOCTA)

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ClinicalTrials.gov Identifier: NCT04593212
Recruitment Status : Not yet recruiting
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Hospital da Luz, Portugal

Brief Summary:

Purpose and rationale: Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis and septic shock are major public health problems killing one in every three patients. Microcirculatory dysfunction is frequent in septic shock. The duration and severity of this dysfunction have a prognostic impact by being associated with organ failure and mortality. Our study purposes to demonstrate the feasibility of optical coherence tomography angiography (OCTA) to improve assessment of microcirculatory dysfunction by showing that retinal and choroidal microcirculatory changes with prognostic impact are present during septic shock.

Primary objective: To characterize the alterations of retinal and choroidal microcirculation in septic shock.

We will test the hypothesis that retinal and/or choroidal microcirculation shows dysfunctional changes (lower vascular density, lower percentage of perfused small vessel, lower blood flow index and higher vascular heterogeneity) in septic shock patients.

Secondary objective: To test the prognostic value of retinal and choroidal microcirculatory dysfunction in septic shock.

We will test the hypothesis that higher magnitude and persistence of retinal and/or choroidal microcirculatory dysfunction beyond the successful macro-hemodynamic resuscitation are independent predictors of organ failure and mortality in septic shock patients.

Study type: Two sequential observational studies.

Study design: A cross-sectional case-control study followed by a prospective cohort study with a 90-days longitudinal follow-up period.

Study population: 165 septic shock patients and 30 healthy controls.

Study duration: 90 days from enrolment to final follow-up assessment. One to two years of enrolment.


Condition or disease Intervention/treatment
Septic Shock Diagnostic Test: Optical Coherence Tomography Angiography

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 165 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improving the Assessment of Microcirculatory Dysfunction in Septic Shock Patients Using Optical Coherence Tomography Angiography at the Bedside
Estimated Study Start Date : February 2021
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Group/Cohort Intervention/treatment
Septic Shock Survivors Diagnostic Test: Optical Coherence Tomography Angiography
Evaluation of microcirculatory dysfunction by assessment of retinal and choroidal microvasculature with optical coherence tomography angiography (OCTA)

Septic Shock Non-Survivors Diagnostic Test: Optical Coherence Tomography Angiography
Evaluation of microcirculatory dysfunction by assessment of retinal and choroidal microvasculature with optical coherence tomography angiography (OCTA)




Primary Outcome Measures :
  1. Percentage of Perfused Small Vessel (PPV) [ Time Frame: Daily assessment from day 0 to a maximum of 7 days ]
    The absolute number of completely perfused small vessels (diameter < 20μm) divided by the absolute number of small vessels (diameter < 20μm).

  2. 28-days All-Cause Mortality [ Time Frame: 28-days after enrollment ]

Secondary Outcome Measures :
  1. Perfused Small Vessel Density (PVD) [ Time Frame: Daily assessment from day 0 to a maximum of 7 days ]
    The percentage area occupied by the small vessels (diameter <20μm)

  2. Blood Flow Index (BFI) [ Time Frame: Daily assessment from day 0 to a maximum of 7 days ]
    The average flow signal

  3. Heterogeneity Index [ Time Frame: Daily assessment from day 0 to a maximum of 7 days ]
    The difference between the highest and the lowest BFI divided by the mean BFI

  4. ICU mortality [ Time Frame: 90-days after enrollment ]
  5. Hospital mortality [ Time Frame: 90-days after enrollment ]
  6. ICU length of stay [ Time Frame: 90-days after enrollment ]
  7. Hospital length of stay [ Time Frame: 90-days after enrollment ]
  8. Ventilator free-days [ Time Frame: 90-days after enrollment ]
  9. Vasopressor free-days [ Time Frame: 90-days after enrollment ]
  10. Renal replacement therapy free-days [ Time Frame: 90-days after enrollment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Source population:

  1. Cross-sectional case-control study: we intend to enrol 30 septic shock patients and 30 healthy controls.
  2. Prospective cohort study: we intend to enrol 165 septic shock patients (the first 30 patients will be the same from the cross-sectional case-control study).

The enrolment will take place from patients admitted to the Intensive Care Medicine Department of Hospital da Luz Lisboa, from February 2021 to February 2022. The healthy controls will be enrolled from our hospital staff.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04593212


Contacts
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Contact: André Alexandre, MD 351217104400 andre.alexandre@hospitaldaluz.pt

Sponsors and Collaborators
Hospital da Luz, Portugal
Investigators
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Principal Investigator: André Alexandre, MD 11170
Publications:

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Responsible Party: Hospital da Luz, Portugal
ClinicalTrials.gov Identifier: NCT04593212    
Other Study ID Numbers: id.215
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Shock, Septic
Shock
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation