NCT00541944

Brief Summary

The prospective clinical diagnosis of hyponatremia is often very difficult- but requirement for an appropriate and riskless treatment of hyponatremia. This study try to establish an algorithm handling a prospective clinical categorization of hyponatremia and approving together the start of an appropriate symptomatic therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
138

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 10, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

May 21, 2024

Status Verified

May 1, 2024

Enrollment Period

1.7 years

First QC Date

October 9, 2007

Last Update Submit

May 18, 2024

Conditions

Hyponatremia

Keywords

hyponatremiadiagnosis and treatment of hyponatremiaclassification of hyponatremia

Outcome Measures

Primary Outcomes (1)

  • Establishment of an clinical algorithm to differentiate the different causes of hyponatremia

    One year

Eligibility Criteria

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

Patients treated in an University Hospital in Germany

You may qualify if:

  • hypoosmolar hyponatremia with serum sodium concentration ≤129 mmol/l and serum osmolality ≤ 280 mosm/kg;
  • age \> 18 years;
  • letter of agreement.

You may not qualify if:

  • gravidity and lactation;
  • restricted decision-making-ability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wuerzburg

Würzburg, 97080, Germany

Location

Related Publications (1)

  • Fenske W, Stork S, Koschker AC, Blechschmidt A, Lorenz D, Wortmann S, Allolio B. Value of fractional uric acid excretion in differential diagnosis of hyponatremic patients on diuretics. J Clin Endocrinol Metab. 2008 Aug;93(8):2991-7. doi: 10.1210/jc.2008-0330. Epub 2008 May 13.

    PMID: 18477658DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, plasma and urine

MeSH Terms

Conditions

HyponatremiaDisease

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bruno Allolio, MD

    Universtiy of Wuerzburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
I am only the successor of the PI of the study, Bruno Allolio, who unfortunately died in the meantime

Study Record Dates

First Submitted

October 9, 2007

First Posted

October 10, 2007

Study Start

April 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

May 21, 2024

Record last verified: 2024-05

Locations

DE(1)