Hyponatremia of Multiple MyelomaNCT01425606
Pseudohyponatremia of Multiple Myeloma is True Hyponatremia
An observational study of Hyponatremia of Multiple Myeloma, run by Meir Medical Center at 1 site in Israel.
Trial summary
Hypothesis: the hyponatremia of multiple myeloma (m.m.)is true and not pseudohyponatremia by using the stewart approach to acid - base interpretation, would like to show that the positive charged m- proteins produced in m.m.result in true hyponatremia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyponatremia of Multiple Myeloma
- What is being tested?
- blood test
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2011to Jun 2012
- 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: patients with gammaglobulinemia and\or multiple myeloma.
Who may be able to join
- patients with multiple myeloma
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Meir Hospital
Kfar Saba
jeffrey sachs, MBChB, 97297471545, jeffrey.sachs@clalit.org.il
About this study
Official title: a Study to Evaluate the Electrolyte Changes in Particular Sodium,in Multiple Myeloma and the Effect of the m- Proteins on the Strong Ion Difference
Hypothesis: the hyponatremia of multiple myeloma (m.m.)is true and not pseudohyponatremia by using the stewart approach to acid - base interpretation, would like to show that the positive charged m- proteins produced in m.m.result in true hyponatremia.
- Conditions
- Hyponatremia of Multiple Myeloma
- Being tested
- blood test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood testOther
blood test to measure levels of: sodium, albumin and acid - base status in venous blood.
| Study group | Role | What they receive |
|---|---|---|
| blood test | to measure levels of sodium, albumin and acid - base status in venous blood Receives: Other: blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
hyponatremia present or not
Measured: one year
hyponatremia
pseoudohyponatremia or not
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyponatremia of Multiple MyelomaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01425606
- Sponsor's protocol ID
- 039-2011
- Status last verified
- Aug 2011
- First submitted
- 9 Jun 2011
- Last updated
- 30 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Study to Evaluate the Electrolyte Changes in Particular Sodium,in Multiple Myeloma and the Effect of the m- Proteins on the Strong Ion Difference
- ClinicalTrials.gov ID
- NCT01425606
- Acronym / sponsor ID
- 039-2011
- Conditions
- Hyponatremia of Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 30 Aug 2011 (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.
Hypothesis: the hyponatremia of multiple myeloma (m.m.)is true and not pseudohyponatremia by using the stewart approach to acid - base interpretation, would like to show that the positive charged m- proteins produced in m.m.result in true hyponatremia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| blood test | – | Other: blood testto measure levels of sodium, albumin and acid - base status in venous blood |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with gammaglobulinemia and\or multiple myeloma.
Key inclusion criteria (1 listed)
- patients with multiple myeloma
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| blood testblood test to measure levels of: sodium, albumin and acid - base status in venous blood. | Other | blood test |
Primary outcome
hyponatremia present or not
Time frame: one year
hyponatremia
Time frame: one year
pseoudohyponatremia or not
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2011.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyponatremia of Multiple Myeloma, run by Meir Medical Center at 1 site in Israel.
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 0 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 30 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hyponatremia present or not (time frame: one year). 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?
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 30 Aug 2011.