Examination of Potassium Levels in Saliva in ESRD Patients

ESRD Clinical Trial

Official title:

Examination of Potassium Levels in Saliva in ESRD Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02596386
• Other study ID #: k001.HMO-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: November 3, 2015
• Last updated: November 3, 2015
• Start date: November 2015
• Est. completion date: November 2017

Study information

• Verified date: October 2015
• Source: Hadassah Medical Organization
• Contact: Doron J Aframian, MD,PhD
• Phone: 97226776140
• Email: dorona[@]hadassah.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: November 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• ESRD

Intervention

Procedure:
• sialometry
potassium evaluation
• blood test
potassium evaluation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	potassium level in saliva		7 days	No
Primary	Standard Biochemistry of blood		7 days	No