Examination of Potassium Levels in Saliva in ESRD Patients

NCT02596386 | Unknown

• 1 other identifier: k001.HMO-CTIL
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

ESRD

Outcome Measures

Primary Outcomes (2)

• potassium level in saliva

  7 days

• Standard Biochemistry of blood

  7 days

Study Arms (2)

potassium level in saliva

Each willing participant will undergo Sialometry

Procedure: sialometry

blood test

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

Procedure: blood test

Interventions

sialometry PROCEDURE

potassium evaluation

potassium level in saliva

blood test PROCEDURE

potassium evaluation

blood test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

ESRD patients on Hemodialysis

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Related Publications (2)

• 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.

  PMID: 25653941 BACKGROUND

• 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.

  PMID: 20921301 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Doron J Aframian, MD,PhD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Doron J Aframian, MD,PhD

CONTACT

97226776140; dorona@hadassah.org.il

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2015
• First Posted: November 4, 2015
• Study Start: November 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2017
• Last Updated: November 4, 2015

Record last verified: 2015-10