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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03044483
Recruitment Status : Unknown
Verified January 2018 by University Hospitals, Leicester.
Recruitment status was:  Active, not recruiting
First Posted : February 7, 2017
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospitals, Leicester

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.


Condition or disease Intervention/treatment
Microcirculation Other: Measurement of sublingual microcirculatory parameters

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Establishing Normal Ranges of Microcirculatory Function as Determined by CytoCam-IDF Imaging
Actual Study Start Date : January 24, 2017
Estimated Primary Completion Date : July 31, 2018
Estimated Study Completion Date : July 31, 2018

Group/Cohort Intervention/treatment
18-34 year olds
Healthy adults aged 18-34 years old
Other: Measurement of sublingual microcirculatory parameters
Measurement of the sublingual microcirculatory function using the CytoCam-IDF imaging device to establish the normal range for each age group noted.

35-54 year olds
Healthy adults aged 35-54 years old
Other: Measurement of sublingual microcirculatory parameters
Measurement of the sublingual microcirculatory function using the CytoCam-IDF imaging device to establish the normal range for each age group noted.

55 and over year olds
Healthy adults aged 55 years old and over
Other: Measurement of sublingual microcirculatory parameters
Measurement of the sublingual microcirculatory function using the CytoCam-IDF imaging device to establish the normal range for each age group noted.




Primary Outcome Measures :
  1. Microvascular Flow Index (MFI, No units) [ Time Frame: 6 months ]
    Measurement of MFI in the the three stated age groups

  2. Total Vessel Density (TVD, mm/mm2) [ Time Frame: 6 months ]
    Measurement of TVD in the three stated age groups

  3. Perfused Vessel Density (PVD, mm/mm2) [ Time Frame: 6 months ]
    Measurement of PVD in the three stated age groups

  4. Proportion of Perfused Vessels (PPV, no units [ Time Frame: 6 months ]
    Measurement of PPV in the three stated age groups



Information from the National Library of Medicine

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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

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): NCT03044483


Locations
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United Kingdom
University Hospitals of Leicester
Leicester, Leicestershire, United Kingdom, LE1 5WW
Sponsors and Collaborators
University Hospitals, Leicester
Investigators
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Principal Investigator: Jonathan Thompson, MBChB Principal Investigator

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Responsible Party: University Hospitals, Leicester
ClinicalTrials.gov Identifier: NCT03044483    
Other Study ID Numbers: 214674
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018
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
Keywords provided by University Hospitals, Leicester:
Sepsis
Microcirculatory function