Establishing Normal Ranges of Microcirculatory Function as Determined by CytoCam-IDF Imaging

NCT03044483 | Completed

• 1 other identifier: 214674
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

When infection strikes, the body's immune system reacts by producing chemicals in the bloodstream and changes in white blood cells to attack the infecting organism (bacteria, viruses or other organisms) and prevent it spreading. This is termed the 'inflammatory response'. Though beneficial in fighting infection, this response can sometimes be excessive, causing harmful effects on body organs. This is termed the 'systemic inflammatory response syndrome' and when linked to infection is termed 'sepsis'. Previous research has shown that in patients who have sepsis, the small blood vessels supplying oxygen and nutrients to muscles and other organs (the microcirculation) become abnormal and do not function as they would in health. However, it is difficult to assess the function of microcirculation in clinical practice, and we want to find new, easier ways of doing so. The aim of this study is to test a new method for assessing the function of these small blood vessels, by directly visualising them using a highly sensitive microscope, the size of a pen, placed under the tongue. By understanding the flow of blood in these vessels in healthy individuals, we will gain a better understanding of how these vessels are affected in illness.

Conditions

Microcirculation

Keywords

Sepsis; Microcirculatory function

Outcome Measures

Primary Outcomes (4)

• Microvascular Flow Index (MFI, No units)

  Measurement of MFI in the the three stated age groups

  6 months

• Total Vessel Density (TVD, mm/mm2)

  Measurement of TVD in the three stated age groups

  6 months

• Perfused Vessel Density (PVD, mm/mm2)

  Measurement of PVD in the three stated age groups

  6 months

• Proportion of Perfused Vessels (PPV, no units

  Measurement of PPV in the three stated age groups

  6 months

Study Arms (3)

18-34 year olds

Healthy adults aged 18-34 years old

Other: Measurement of sublingual microcirculatory parameters

35-54 year olds

Healthy adults aged 35-54 years old

Other: Measurement of sublingual microcirculatory parameters

55 and over year olds

Healthy adults aged 55 years old and over

Other: Measurement of sublingual microcirculatory parameters

Interventions

Measurement of sublingual microcirculatory parameters OTHER

Measurement of the sublingual microcirculatory function using the CytoCam-IDF imaging device to establish the normal range for each age group noted.

18-34 year olds; 35-54 year olds; 55 and over year olds

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

Healthy adults aged 18 years and over, with no acute illness

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study.
• Male or Female, aged 18 years or above.
• No current acute illness
• No changes to chronic medications in the 4-weeks preceding recruitment.
• Able and willing to comply with all study requirements.

You may not qualify if:

• Participant aged under 18 years old.
• Participant has an acute illness, as identified by clinical history
• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
• Participants awaiting maxillofacial surgery for any reason.
• Participants who have participated in another research study involving an investigational product in the past 12 weeks

Sponsors & Collaborators

• University Hospitals, Leicester: lead

Study Sites (1)

University Hospitals of Leicester

Leicester, Leicestershire, LE1 5WW, United Kingdom

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

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

Study Officials

• Jonathan Thompson, MBChB

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2017
• First Posted: February 7, 2017
• Study Start: July 6, 2017
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: December 12, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)