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

NCT ID: NCT01684228

Last Updated: 2015-05-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 37 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2012-09-30

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.

Conditions

End Stage Renal Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Age under 18
• Pregnancy
• Malignancy
• Infectious diseases

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rambam Health Care Campus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suheir Assady, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Department of Nephrology, Rambam-Health Care Campus

Locations

Rambam Health Care Campus

Haifa, , Israel

Countries

Israel

Other Identifiers

0271-10-RMB-CTIL

Identifier Type: -

Identifier Source: org_study_id