ESRDNCT02596386
Examination of Potassium Levels in Saliva in ESRD Patients
An observational study of ESRD, run by Hadassah Medical Organization.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ESRD
- What is being tested?
- sialometry and blood test
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ESRD patients on Hemodialysis
Who may be able to join
- Present a predialysis serum potassium level over 5 mmol/L.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read more
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
- Being tested
- sialometry, blood test
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sialometryProcedure or surgery
potassium evaluation
blood testProcedure or surgery
potassium evaluation
| Study group | Role | What they receive |
|---|---|---|
| potassium level in saliva | Each willing participant will undergo Sialometry Receives: Procedure: sialometry | |
| blood test | blood will be drawn from the dialysis connections for Biochemistry for potassium level evaluation Receives: Procedure: blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
potassium level in saliva
Measured: 7 days
Standard Biochemistry of blood
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2016 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ESRDStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Doron J Aframian, MD,PhD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596386
- Sponsor's protocol ID
- k001.HMO-CTIL
- Status last verified
- Oct 2015
- First submitted
- 3 Nov 2015
- Last updated
- 4 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25653941Davidovich 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.
PubMed 20921301
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Potassium Levels in Saliva in ESRD Patients
- ClinicalTrials.gov ID
- NCT02596386
- Acronym / sponsor ID
- k001.HMO-CTIL
- Conditions
- ESRD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 4 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| potassium level in saliva | – | Procedure: sialometryEach willing participant will undergo Sialometry |
| blood test | – | Procedure: blood testblood will be drawn from the dialysis connections for Biochemistry for potassium level evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ESRD patients on Hemodialysis
Key inclusion criteria (1 listed)
- Present a predialysis serum potassium level over 5 mmol/L.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sialometrypotassium evaluation | Procedure or surgery | potassium level in saliva |
| blood testpotassium evaluation | Procedure or surgery | blood test |
Primary outcome
potassium level in saliva
Time frame: 7 days
Standard Biochemistry of blood
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2015.
- Background: PubMed 25653941Seethalakshmi 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.
- Background: PubMed 20921301Davidovich 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doron J Aframian, MD,PhD principal investigator
Hadassah Medical Organization
Questions about this trial
What is this clinical trial studying?
An observational study of ESRD, run by Hadassah Medical Organization.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Doron J Aframian, MD,PhD (97226776140, dorona@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
potassium level in saliva (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02596386, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2015.