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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01684228
First received: September 10, 2012
Last updated: September 12, 2012
Last verified: September 2012
  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


Estimated Enrollment: 150
Study Start Date: August 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01684228     History of Changes
Other Study ID Numbers: 0271-10-RMB-CTIL
Study First Received: September 10, 2012
Last Updated: September 12, 2012
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on September 18, 2014