Examination of Potassium Levels in Saliva in ESRD Patients

November 3, 2015 updated by: Hadassah Medical Organization

Dialysis patients typically undergo 3 treatments a week every other day with an almost 3 day gap during the weekend. After this gap and before the first dialysis of the week the serum Potassium level is expected to be maximal.

Participants will be recruited from the dialysis clinic at Hadassah Ein Kerem Hospital. The research team would personally meet the patients who answer inclusion criteria f and ask whether they wish to participate.

Each willing participant will undergo Sialometry and blood will be drawn from the dialysis connections for CBC and Biochemistry to establish a baseline.

The study measurements namely Sialometry and collection of Saliva as well as blood test will be taken before the initiation of the dialysis.

Blood testing will be done via the laboratories of the Hadassah hospital. Saliva analysis will be done in the research lab of Prof. Doron Aframian.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

ESRD patients on Hemodialysis

Description

Inclusion Criteria:

  • Present a predialysis serum potassium level over 5 mmol/L.

Exclusion Criteria:

  • Pregnancy

Patients diagnosed with a pathology of the salivary glands such as Sjogren's syndrome, Sialosis, Sialadenitis.

Patients who have received previous radiation therapy to the head and neck region

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
potassium level in saliva
Each willing participant will undergo Sialometry
Procedure: sialometry
potassium evaluation
blood test
blood will be drawn from the dialysis connections for Biochemistry for potassium level evaluation
Procedure: blood test
potassium evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
potassium level in saliva
Time Frame: 7 days
7 days
Standard Biochemistry of blood
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Investigators

  • Principal Investigator: Doron J Aframian, MD,PhD, Hadassah Medical Organization

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

November 1, 2017

Study Registration Dates

First Submitted

November 3, 2015

First Submitted That Met QC Criteria

November 3, 2015

First Posted (Estimate)

November 4, 2015

Study Record Updates

Last Update Posted (Estimate)

November 4, 2015

Last Update Submitted That Met QC Criteria

November 3, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • k001.HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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