Renal FailureNCT02369237
Non-invasive Determination of Anemia in Children With Renal Failure
An observational study of Renal Failure, run by Center for Studies of Sensory Impairment, Aging and Metabolism.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Renal Failure
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- all children in treatment for renal insufficiency in FUNDANIER
Who cannot join
- none
About this study
Official title: 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.
- Conditions
- Renal Failure
- Medical subject headings
- Renal Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin
Measured: 1 day
Iron parameters
Serum iron, ferritin, transferrin, transferrin saturation, TIBC, hepcidin
Measured: 1 day
Inflammation parameters
Ferritin, hepcidin, CRP, white blood cell count, ESR
Measured: 1 day
Secondary outcomes (1)
anthropometric data
weight, height, WAZ, HAZ and WHZ
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study startApr 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Studies of Sensory Impairment, Aging and Metabolism
- Sponsor type
- University, hospital or other
- Collaborators
- Hildegrad Grunow Foundation, MBR Optical Systems
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02369237
- Sponsor's protocol ID
- CeSSIAM_03
- Status last verified
- Feb 2012
- First submitted
- 17 Feb 2015
- Last updated
- 23 Feb 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-invasive Device to Determine Iron Deficiency Anemia in Children of Different Age Groups With Renal Failure
- ClinicalTrials.gov ID
- NCT02369237
- Acronym / sponsor ID
- CeSSIAM_03
- Conditions
- Renal Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Center for Studies of Sensory Impairment, Aging and MetabolismUniversity, hospital or other
- Collaborators
- Hildegrad Grunow Foundation, MBR Optical Systems
- Study start
- Apr 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 23 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- all children in treatment for renal insufficiency in FUNDANIER
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hemoglobin
Time frame: 1 day
Iron parameters
Time frame: 1 day
Serum iron, ferritin, transferrin, transferrin saturation, TIBC, hepcidin
Inflammation parameters
Time frame: 1 day
Ferritin, hepcidin, CRP, white blood cell count, ESR
1 secondary outcome
anthropometric data
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Failure, run by Center for Studies of Sensory Impairment, Aging and Metabolism.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2015.