Assessment of Microcirculatory Dysfunction in Septic Shock Patients by OCTA

NCT04593212 | Unknown

• 1 other identifier: id.215
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (2)

• Percentage of Perfused Small Vessel (PPV)

  The absolute number of completely perfused small vessels (diameter \< 20μm) divided by the absolute number of small vessels (diameter \< 20μm).

  Daily assessment from day 0 to a maximum of 7 days

• 28-days All-Cause Mortality

  28-days after enrollment

Secondary Outcomes (10)

• Perfused Small Vessel Density (PVD)

  Daily assessment from day 0 to a maximum of 7 days

• Blood Flow Index (BFI)

  Daily assessment from day 0 to a maximum of 7 days

• Heterogeneity Index

  Daily assessment from day 0 to a maximum of 7 days

• ICU mortality

  90-days after enrollment

• Hospital mortality

  90-days after enrollment

Study Arms (2)

Septic Shock Survivors

Diagnostic Test: Optical Coherence Tomography Angiography

Septic Shock Non-Survivors

Diagnostic Test: Optical Coherence Tomography Angiography

Interventions

Optical Coherence Tomography Angiography DIAGNOSTIC_TEST

Evaluation of microcirculatory dysfunction by assessment of retinal and choroidal microvasculature with optical coherence tomography angiography (OCTA)

Septic Shock Non-Survivors; Septic Shock Survivors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital da Luz, Portugal: lead

Study Sites (1)

Hospital da Luz Lisboa

Lisbon, 1500-060, Portugal

RECRUITING

Related Publications (15)

• De Backer D, Cecconi M, Lipman J, Machado F, Myatra SN, Ostermann M, Perner A, Teboul JL, Vincent JL, Walley KR. Challenges in the management of septic shock: a narrative review. Intensive Care Med. 2019 Apr;45(4):420-433. doi: 10.1007/s00134-019-05544-x. Epub 2019 Feb 11.

  PMID: 30741328 BACKGROUND

• Lipinska-Gediga M. Sepsis and septic shock-is a microcirculation a main player? Anaesthesiol Intensive Ther. 2016;48(4):261-265. doi: 10.5603/AIT.a2016.0037. Epub 2016 Sep 23.

  PMID: 27660252 BACKGROUND

• Ince C. Hemodynamic coherence and the rationale for monitoring the microcirculation. Crit Care. 2015;19 Suppl 3(Suppl 3):S8. doi: 10.1186/cc14726. Epub 2015 Dec 18.

  PMID: 26729241 BACKGROUND

• Ait-Oufella H, Bourcier S, Lehoux S, Guidet B. Microcirculatory disorders during septic shock. Curr Opin Crit Care. 2015 Aug;21(4):271-5. doi: 10.1097/MCC.0000000000000217.

  PMID: 26103150 BACKGROUND

• Ince C. The rationale for microcirculatory guided fluid therapy. Curr Opin Crit Care. 2014 Jun;20(3):301-8. doi: 10.1097/MCC.0000000000000091.

  PMID: 24758985 BACKGROUND

• De Backer D, Donadello K, Sakr Y, Ospina-Tascon G, Salgado D, Scolletta S, Vincent JL. Microcirculatory alterations in patients with severe sepsis: impact of time of assessment and relationship with outcome. Crit Care Med. 2013 Mar;41(3):791-9. doi: 10.1097/CCM.0b013e3182742e8b.

  PMID: 23318492 BACKGROUND

• Spaide RF, Fujimoto JG, Waheed NK, Sadda SR, Staurenghi G. Optical coherence tomography angiography. Prog Retin Eye Res. 2018 May;64:1-55. doi: 10.1016/j.preteyeres.2017.11.003. Epub 2017 Dec 8.

  PMID: 29229445 BACKGROUND

• Onishi AC, Fawzi AA. An overview of optical coherence tomography angiography and the posterior pole. Ther Adv Ophthalmol. 2019 Apr 3;11:2515841419840249. doi: 10.1177/2515841419840249. eCollection 2019 Jan-Dec.

  PMID: 30984909 BACKGROUND

• Sambhav K, Grover S, Chalam KV. The application of optical coherence tomography angiography in retinal diseases. Surv Ophthalmol. 2017 Nov-Dec;62(6):838-866. doi: 10.1016/j.survophthal.2017.05.006. Epub 2017 Jun 1.

  PMID: 28579550 BACKGROUND

• Alnawaiseh M, Ertmer C, Seidel L, Arnemann PH, Lahme L, Kampmeier TG, Rehberg SW, Heiduschka P, Eter N, Hessler M. Feasibility of optical coherence tomography angiography to assess changes in retinal microcirculation in ovine haemorrhagic shock. Crit Care. 2018 May 29;22(1):138. doi: 10.1186/s13054-018-2056-3.

  PMID: 29843760 BACKGROUND

• Erikson K, Liisanantti JH, Hautala N, Koskenkari J, Kamakura R, Herzig KH, Syrjala H, Ala-Kokko TI. Retinal arterial blood flow and retinal changes in patients with sepsis: preliminary study using fluorescein angiography. Crit Care. 2017 Apr 10;21(1):86. doi: 10.1186/s13054-017-1676-3.

  PMID: 28395665 BACKGROUND

• De Backer D, Creteur J, Preiser JC, Dubois MJ, Vincent JL. Microvascular blood flow is altered in patients with sepsis. Am J Respir Crit Care Med. 2002 Jul 1;166(1):98-104. doi: 10.1164/rccm.200109-016oc.

  PMID: 12091178 BACKGROUND

• Sakr Y, Dubois MJ, De Backer D, Creteur J, Vincent JL. Persistent microcirculatory alterations are associated with organ failure and death in patients with septic shock. Crit Care Med. 2004 Sep;32(9):1825-31. doi: 10.1097/01.ccm.0000138558.16257.3f.

  PMID: 15343008 BACKGROUND

• Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

  PMID: 26903338 BACKGROUND

• Povoa P, Salluh JI, Martinez ML, Guillamat-Prats R, Gallup D, Al-Khalidi HR, Thompson BT, Ranieri VM, Artigas A. Clinical impact of stress dose steroids in patients with septic shock: insights from the PROWESS-Shock trial. Crit Care. 2015 Apr 28;19(1):193. doi: 10.1186/s13054-015-0921-x.

  PMID: 25928214 BACKGROUND

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• André Alexandre, MD

  11170

  PRINCIPAL INVESTIGATOR

Central Study Contacts

André Alexandre, MD

CONTACT

351217104400; andre.alexandre@hospitaldaluz.pt

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 19, 2020
• Study Start: February 16, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)