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

Sponsor
Rambam Health Care Campus (Other)
Overall Status
Completed
CT.gov ID
NCT01684228
Collaborator
(none)
37
Enrollment
1
Location
25
Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    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 :
    Aug 1, 2010
    Actual Primary Completion Date :
    Sep 1, 2012
    Actual Study Completion Date :
    Sep 1, 2012

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      Inclusion Criteria:

      • 18 Years and older

      • End stage renal disease receiving hemodialysis

      Exclusion Criteria:

      • Age under 18

      • Pregnancy

      • Malignancy

      • Infectious diseases

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 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

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Rambam Health Care Campus
      ClinicalTrials.gov Identifier:
      NCT01684228
      Other Study ID Numbers:
      • 0271-10-RMB-CTIL
      First Posted:
      Sep 12, 2012
      Last Update Posted:
      May 7, 2015
      Last Verified:
      May 1, 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

      Study Results

      No Results Posted as of May 7, 2015