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

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. Identifier: NCT01684228
Recruitment Status : Completed
First Posted : September 12, 2012
Last Update Posted : May 7, 2015
Information provided by (Responsible Party):
Rambam Health Care Campus

Brief Summary:

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 or disease
End Stage Renal Disease

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Study Type : Observational
Actual Enrollment : 37 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Impact of Hemodialysis on Exhaled Volatile Organic Compounds in End Stage Renal Disease
Study Start Date : August 2010
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Biospecimen Retention:   Samples Without DNA
exhaled breath

Information from the National Library of Medicine

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

Inclusion Criteria:

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

Exclusion Criteria:

  • Age under 18
  • Pregnancy
  • Malignancy
  • Infectious diseases

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 identifier (NCT number): NCT01684228

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

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Responsible Party: Rambam Health Care Campus Identifier: NCT01684228    
Other Study ID Numbers: 0271-10-RMB-CTIL
First Posted: September 12, 2012    Key Record Dates
Last Update Posted: May 7, 2015
Last Verified: May 2015
Keywords provided by Rambam Health Care Campus:
End stage renal disease
breath test
volatile organic compound
dialysis adequacy
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency