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OpenTrials
Completed

NCT Number: NCT02369237

Non-invasive Determination of Anemia in Children With Renal Failure

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.

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Key information

Conditions

Renal Failure Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all children in treatment for renal insufficiency in FUNDANIER

Exclusion criteria

  • none

Treatment and study plan

Primary outcomes

  1. Hemoglobin

    Time frame: 1 day

  2. Iron parameters

    Time frame: 1 day

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

  3. Inflammation parameters

    Time frame: 1 day

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

Secondary outcomes

  1. anthropometric data

    Time frame: 1 day

    weight, height, WAZ, HAZ and WHZ

Sponsors and collaborators

Lead sponsor

Center for Studies of Sensory Impairment, Aging and Metabolism

Other

Collaborators

  • Hildegrad Grunow Foundation
  • MBR Optical Systems

Registry information

Official study title

A Non-invasive Device to Determine Iron Deficiency Anemia in Children of Different Age Groups With Renal Failure

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 23, 2015
Registry last updated
Feb 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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