Examination of Potassium Levels in Saliva in ESRD Patients

NCT ID: NCT02596386

Last Updated: 2015-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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ESRD

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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potassium level in saliva

Each willing participant will undergo Sialometry

sialometry

Intervention Type PROCEDURE

potassium evaluation

blood test

blood will be drawn from the dialysis connections for Biochemistry for potassium level evaluation

blood test

Intervention Type PROCEDURE

potassium evaluation

Interventions

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sialometry

potassium evaluation

Intervention Type PROCEDURE

blood test

potassium evaluation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Doron J Aframian, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Central Contacts

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Doron J Aframian, MD,PhD

Role: CONTACT

97226776140

References

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Seethalakshmi C, Koteeswaran D, Chiranjeevi V. Correlation of Serum and Salivary Biochemical Parameters in end Stage Renal Disease Patients Undergoing Hemodialysis in Pre and Post-Dialysis State. J Clin Diagn Res. 2014 Dec;8(12):CC12-4. doi: 10.7860/JCDR/2014/10404.5306. Epub 2014 Dec 5.

Reference Type BACKGROUND
PMID: 25653941 (View on PubMed)

Davidovich E, Davidovits M, Peretz B, Shapira J, Aframian DJ. Elevated salivary potassium in paediatric CKD patients, a novel excretion pathway. Nephrol Dial Transplant. 2011 May;26(5):1541-6. doi: 10.1093/ndt/gfq587. Epub 2010 Oct 4.

Reference Type BACKGROUND
PMID: 20921301 (View on PubMed)

Other Identifiers

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k001.HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id

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