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Impact of Hemodialysis on Exhaled Volatile Organic Compounds in End Stage Renal Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01684228
First Posted: September 12, 2012
Last Update Posted: May 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rambam Health Care Campus
  Purpose

End stage renal disease (ESRD) is a severe clinical state of irreversible loss of endogenous kidney function, shortening life expectancy, if left untreated. In the state of ESRD, over 5000 uremic toxins are accumulated in the body causing dysfunction of various organ systems. The survival of these patients depends on renal replacement therapies, such as hemodialysis (HD), which artificially purifies the blood from toxins. The investigators assume that some of the uremic toxins are also present in the patient's exhaled breath, and could be detected by a non-invasive and highly sensitive test: a NA-NOSE artificial olfactory system. It is based on analysis of volatile organic compounds (VOCs), a novel, non-invasive field in medical diagnostics. The NA-NOSE is made from an array of nanosensors, and was developed by our collaborator Dr. Hossam Haick (Chemical Engineering, Technion).

In the current study, the investigators utilize this technology to identify VOCs in the exhaled breath of dialysis patients, and to characterize certain patterns of expression that could potentially help in future monitoring of HD adequacy. The investigators plan to collect 150 breath samples from patients before and during dialysis, and from healthy subjects. All participants provide a signed informed consent. Subsequently, analysis of samples will be done at Dr. Haick's laboratory, using Gas-Chromatography/Mass-Spectrometry and parameters extracted from each sensor response.


Condition
End Stage Renal Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Impact of Hemodialysis on Exhaled Volatile Organic Compounds in End Stage Renal Disease

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Biospecimen Retention:   Samples Without DNA
exhaled breath

Enrollment: 37
Study Start Date: August 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Hemodialysis patients
Criteria

Inclusion Criteria:

  • 18 Years and older
  • End stage renal disease receiving hemodialysis

Exclusion Criteria:

  • Age under 18
  • Pregnancy
  • Malignancy
  • Infectious diseases
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01684228


Locations
Israel
Rambam Health Care Campus
Haifa, Israel, 31096
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Suheir Assady, MD, Ph.D Department of Nephrology, Rambam-Health Care Campus
  More Information

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01684228     History of Changes
Other Study ID Numbers: 0271-10-RMB-CTIL
First Submitted: September 10, 2012
First Posted: September 12, 2012
Last Update Posted: May 7, 2015
Last Verified: May 2015

Keywords provided by Rambam Health Care Campus:
End stage renal disease
hemodialysis
breath test
volatile organic compound
dialysis adequacy

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency