NCT01425606

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2011

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 30, 2011

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

August 30, 2011

Status Verified

August 1, 2011

Enrollment Period

9 months

First QC Date

June 9, 2011

Last Update Submit

August 28, 2011

Conditions

Hyponatremia of Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

  • hyponatremia present or not

    one year

  • hyponatremia

    pseoudohyponatremia or not

    one year

Study Arms (1)

blood test

to measure levels of sodium, albumin and acid - base status in venous blood

Other: blood test

Interventions

blood testOTHER

blood test to measure levels of: sodium, albumin and acid - base status in venous blood.

blood test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with gammaglobulinemia and\\or multiple myeloma.

You may qualify if:

  • patients with multiple myeloma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Hospital

Kfar Saba, Israel

Location

MeSH Terms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2011

First Posted

August 30, 2011

Study Start

September 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

August 30, 2011

Record last verified: 2011-08

Locations

IL(1)