Non-invasive Determination of Anemia in Children With Renal Failure

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

Study Overview

• Status: Completed
• Conditions: Renal Failure

• Study Type: Observational
• Enrollment (Actual): 54

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The subjects (n ≈ 80) will be enrolled in the Fundación del Niño Enfermo Renal (FUNDANIER) in Guatemala-City. Approximately 50% of the patients in this institution are on hemodialysis and 50% are on peritoneal dialysis.

Description

Inclusion Criteria:

• all children in treatment for renal insufficiency in FUNDANIER

Exclusion Criteria:

• none

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin		1 day
Iron parameters	Serum iron, ferritin, transferrin, transferrin saturation, TIBC, hepcidin	1 day
Inflammation parameters	Ferritin, hepcidin, CRP, white blood cell count, ESR	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anthropometric data	weight, height, WAZ, HAZ and WHZ	1 day

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: February 17, 2015
• First Submitted That Met QC Criteria: February 17, 2015
• First Posted (Estimate): February 23, 2015

Study Record Updates

• Last Update Posted (Estimate): February 23, 2015
• Last Update Submitted That Met QC Criteria: February 17, 2015
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency
• Other Study ID Numbers: CeSSIAM_03