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Pseudohyponatremia of Multiple Myeloma is True Hyponatremia

This study is not yet open for participant recruitment.
Verified August 2011 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01425606
First received: June 9, 2011
Last updated: August 28, 2011
Last verified: August 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Hyponatremia of Multiple Myeloma
 Other: blood test
 Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • hyponatremia present or not [ Time Frame: one year ] [ Designated as safety issue: No ]
  • hyponatremia [ Time Frame: one year ] [ Designated as safety issue: No ]
    pseoudohyponatremia or not


Estimated Enrollment: 50
Study Start Date: September 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
blood test
to measure levels of sodium, albumin and acid - base status in venous blood
 Other: blood test
blood test to measure levels of: sodium, albumin and acid - base status in venous blood.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with gammaglobulinemia and\or multiple myeloma.

Criteria

Inclusion Criteria:

  • patients with multiple myeloma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01425606

Locations
Israel
Meir Hospital Not yet recruiting
Kfar Saba, Israel
Contact: jeffrey sachs, MBChB     97297471545     jeffrey.sachs@clalit.org.il    
Sponsors and Collaborators
Meir Medical Center
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01425606     History of Changes
Other Study ID Numbers: 039-2011
Study First Received: June 9, 2011
Last Updated: August 28, 2011
Health Authority: Israel: Ethics Commission

Additional relevant MeSH terms:
Water-Electrolyte Imbalance
Hyponatremia
Multiple Myeloma
Neoplasms, Plasma Cell
Metabolic Diseases
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
 Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013