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Non-invasive Determination of Anemia in Children With Renal Failure

Sponsor
Center for Studies of Sensory Impairment, Aging and Metabolism (Other)
Overall Status
Completed
CT.gov ID
NCT02369237
Collaborator
Hildegrad Grunow Foundation (Other), MBR Optical Systems (Other)
54
Enrollment
2
Duration (Months)

Study Details

Study Description

Brief Summary

Anemia and inflammation are very common in patients with renal diseases. The most common procedure to detect anemia is to determine blood hemoglobin concentrations. The Haemospect® is a portable device for non-invasive hemoglobin determination that works with a sensor that is applicable in infants and adults alike.

The objective of this trial is to collect spectra with the non-invasive Haemospect® device in children of different age groups with renal failure and different hemoglobin concentrations. In parallel, corresponding hemoglobin values shall be obtained invasively to form the basis for the development of an algorithm for the device.

To determine inflammation, the frequencies of vasomotion and oxygenation of the tissue are measured non-invasively with the Haemospect®. Various blood parameters for iron and inflammation will also be determined, such as ferritin, hepcidin, transferrin, serum iron, white blood cell count and CRP.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    54 participants
    Time Perspective:
    Cross-Sectional
    Official Title:
    A Non-invasive Device to Determine Iron Deficiency Anemia in Children of Different Age Groups With Renal Failure
    Study Start Date :
    Apr 1, 2012
    Actual Primary Completion Date :
    Jun 1, 2012
    Actual Study Completion Date :
    Jun 1, 2012

    Outcome Measures

    Primary Outcome Measures

    1. Hemoglobin [1 day]

    2. Iron parameters [1 day]

      Serum iron, ferritin, transferrin, transferrin saturation, TIBC, hepcidin

    3. Inflammation parameters [1 day]

      Ferritin, hepcidin, CRP, white blood cell count, ESR

    Secondary Outcome Measures

    1. anthropometric data [1 day]

      weight, height, WAZ, HAZ and WHZ

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • all children in treatment for renal insufficiency in FUNDANIER
    Exclusion Criteria:
    • none

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Center for Studies of Sensory Impairment, Aging and Metabolism
    • Hildegrad Grunow Foundation
    • MBR Optical Systems

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Center for Studies of Sensory Impairment, Aging and Metabolism
    ClinicalTrials.gov Identifier:
    NCT02369237
    Other Study ID Numbers:
    • CeSSIAM_03
    First Posted:
    Feb 23, 2015
    Last Update Posted:
    Feb 23, 2015
    Last Verified:
    Feb 1, 2012
    Additional relevant MeSH terms:
    Renal Insufficiency

    Study Results

    No Results Posted as of Feb 23, 2015