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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
September 10, 2012
September 12, 2012
May 7, 2015
August 2010
September 2012   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01684228 on ClinicalTrials.gov Archive Site
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Impact of Hemodialysis on Exhaled Volatile Organic Compounds in End Stage Renal Disease
Impact of Hemodialysis on Exhaled Volatile Organic Compounds in End Stage Renal Disease

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:
exhaled breath
Non-Probability Sample
Hemodialysis patients
End Stage Renal Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
September 2012
September 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Age under 18
  • Pregnancy
  • Malignancy
  • Infectious diseases
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT01684228
0271-10-RMB-CTIL
No
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Rambam Health Care Campus
Rambam Health Care Campus
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Principal Investigator: Suheir Assady, MD, Ph.D Department of Nephrology, Rambam-Health Care Campus
Rambam Health Care Campus
May 2015