Hyponatremia Registry for Patients With Euvolemic and Hypervolemic Hyponatremia
Status: | Completed |
---|---|
Conditions: | Metabolic |
Therapuetic Areas: | Pharmacology / Toxicology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 7/11/2015 |
Start Date: | September 2010 |
End Date: | March 2012 |
An Observational Prospective Registry to Identify Demographic and Clinical Characteristics of Patients Hospitalized With Euvolemic and Hypervolemic Hyponatremia and Assess the Comparative Effectiveness of Available Treatments and the Impact on Resource Utilization
The registry is a multi-center, prospective, observational study designed to collect data in
patients with euvolemic and hypervolemic hyponatremia in the hospital setting in the USA and
hyponatremia secondary to syndrome of inappropriate antidiuretic hormone secretion (SIADH)
in Europe; patients with hypovolemic hyponatremia will be excluded from the registry. The
registry is observational in design, and the registry will collect data on patients with a
serum sodium ≤130 mmol/L. Data from the patients' chart will be collected throughout the
duration of the hospital, from admission to discharge, and the data will be entered into the
case report form (CRF) or into an electronic data capture (EDC) system. These patients will
be entered into the registry over the duration of 18 months at community, tertiary, and
academic medical centers from diverse multiple regions of the USA and Europe.
A patient's treatment will be determined by their caregiver and not by this protocol. Thus,
the registry will provide a unique opportunity to evaluate how the patients are managed
under real-world management conditions.
patients with euvolemic and hypervolemic hyponatremia in the hospital setting in the USA and
hyponatremia secondary to syndrome of inappropriate antidiuretic hormone secretion (SIADH)
in Europe; patients with hypovolemic hyponatremia will be excluded from the registry. The
registry is observational in design, and the registry will collect data on patients with a
serum sodium ≤130 mmol/L. Data from the patients' chart will be collected throughout the
duration of the hospital, from admission to discharge, and the data will be entered into the
case report form (CRF) or into an electronic data capture (EDC) system. These patients will
be entered into the registry over the duration of 18 months at community, tertiary, and
academic medical centers from diverse multiple regions of the USA and Europe.
A patient's treatment will be determined by their caregiver and not by this protocol. Thus,
the registry will provide a unique opportunity to evaluate how the patients are managed
under real-world management conditions.
Inclusion Criteria:
- Adults ≥18 years old who are hospitalized
- Euvolemic or hypervolemic hyponatremia with serum sodium ≤130mmol/L
- For euvolemic hyponatremia:
- Euvolemia is defined as: absence of clinical and historical evidence of
extracellular fluid volume depletion or sequestration; and absence of edema and
ascites; or
- Physician diagnosis of SIADH
- For hypervolemic hyponatremia (applies to USA sites only):
- Hypervolemia is defined as: excess extracellular fluid volume manifesting as
dependent edema or ascites
- Patients may have one or more of the following underlying co-morbid conditions:
- Congestive heart failure
- Cirrhosis and/or liver failure
- Nephrotic syndrome
Exclusion Criteria:
- Patients with hypovolemic hyponatremia
- Use of investigational drug, biologic, or device during the study
We found this trial at
75
sites
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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
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Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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1800 West Charleston Boulevard
Las Vegas, Nevada 89102
Las Vegas, Nevada 89102
(702) 383-2000
University Medical Center of Southern Nevada University Medical Center is dedicated to providing the highest...
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Mount Sinai School of Medicine Icahn School of Medicine at Mount Sinai is proud to...
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The Florida Hospital Florida Hospital is one of the country’s largest not-for-profit health care providers...
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University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Maimonides Medical Center At 103 years old, Maimonides Medical Center remains a vital and thriving...
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Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
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Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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701 Park Ave
Minneapolis, Minnesota 55415
Minneapolis, Minnesota 55415
(612) 873-3000
Hennepin County Medical Center - Minneapolis Hennepin Healthcare System, Inc. operates Hennepin County Medical Center...
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Sentara Norfolk General Hospital Sentara Norfolk General Hospital is recognized as the number one ranked...
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Creighton University Creighton University, located in Omaha, Neb., offers a top-ranked education in the Jesuit...
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Virginia Commonwealth University Medical Center The Virginia Commonwealth University Health System is an urban, comprehensive...
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Virginia Commonwealth University Medical Center The Virginia Commonwealth University Health System is an urban, comprehensive...
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
Washington, District of Columbia 20007
(202) 444-2000
Georgetown University Hospital MedStar Georgetown University Hospital is a not-for-profit, acute-care teaching and research hospital...
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