Non-invasive Determination of Anemia in Children With Renal Failure

Renal Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02369237
• Other study ID #: CeSSIAM_03
• Status: Completed
• Phase: N/A
• First received: February 17, 2015
• Last updated: February 17, 2015
• Start date: April 2012
• Est. completion date: June 2012

Study information

• Verified date: February 2012
• Source: Center for Studies of Sensory Impairment, Aging and Metabolism
• Contact: n/a
• Is FDA regulated: No
• Health authority: Guatemala: Ministry of Public Health and Social Assistance
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• all children in treatment for renal insufficiency in FUNDANIER

Exclusion Criteria:

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Renal Failure
• Renal Insufficiency

Locations

Country	Name	City	State
n/a

Sponsors (3)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin		1 day	No
Primary	Iron parameters	Serum iron, ferritin, transferrin, transferrin saturation, TIBC, hepcidin	1 day	No
Primary	Inflammation parameters	Ferritin, hepcidin, CRP, white blood cell count, ESR	1 day	No
Secondary	anthropometric data	weight, height, WAZ, HAZ and WHZ	1 day	No