NCT02369237

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2012

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2015

Completed
Last Updated

February 23, 2015

Status Verified

February 1, 2012

Enrollment Period

2 months

First QC Date

February 17, 2015

Last Update Submit

February 17, 2015

Conditions

Renal Failure

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • anthropometric data

    1 day

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • all children in treatment for renal insufficiency in FUNDANIER

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2015

First Posted

February 23, 2015

Study Start

April 1, 2012

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

February 23, 2015

Record last verified: 2012-02