Hyponatremia Clinical Trial
Official title:
Comparison of the Vasopressin-2 Antagonist Tolvaptan and Fluid Restriction in the Treatment of Hyponatremia Following Pituitary Surgery
NCT number | NCT04119206 |
Other study ID # | Tolvaptan |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2009 |
Est. completion date | December 31, 2013 |
Verified date | October 2019 |
Source | University of Erlangen-Nürnberg Medical School |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Context. The relevance of hyponatremia has been acknowledged by guidelines from the United
States of America (2013) and Europe (2014). However, treatment recommendations differ due to
limited evidence.
Objective. In hyponatremia following pituitary surgery - caused by the syndrome of
inappropriate antidiuretic hormone (SIADH) secretion - the investigators compared fluid
restriction with the pharmacological increase of water excretion by blocking the vasopressin
2 receptors with tolvaptan at a low and moderate dose.
Design. Prospective observational study.
Setting. Neurosurgical Department of a University hospital with more 200 pituitary procedures
per year.
Patients. Participants undergoing surgery for sellar lesions and developing a serum sodium
below 135 mmol/L. The diagnosis of SIADH was established by eu- or hypervolemia (daily
measurement of body weight and fluid balance daily), an inappropriately concentrated urine
(specific gravity) and exclusion of a cortico- and thyreotropic insufficiency.
Intervention. Participants were treated with fluid restriction (n=38) or tolvaptan at 3.75
(n=38) or 7.5 mg (n=48) orally.
Main Outcome Measures. Treatment efficacy was assessed by the duration of hyponatremia,
sodium nadir and length of hospitalization. Safety was established by an increment serum
sodium below 10 mmol/L per day and exclusion of side effects.
Status | Completed |
Enrollment | 334 |
Est. completion date | December 31, 2013 |
Est. primary completion date | December 31, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Informed written consent was given by the participant or the next-of-kin. Exclusion Criteria: Age below 18 years Pregnancy Tolvaptan intolerance. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Erlangen-Nürnberg Medical School |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean serum sodium concentration | Postoperative mean serum sodium | Day 1 post-op up to 15 days | |
Primary | Serum sodium nadir concentration | Postoperative serum sodium nadir | Day 1 post-op up to 15 days | |
Primary | Number of days with serum sodium concentration below 136mmol/L | No. of postoperative days serum sodium was below 136mmol/L | Day 1 post-op up to 15 days | |
Primary | Number of days with serum sodium concentration below 133mmol/L | No. of postoperative days serum sodium was below 133mmol/L | Day 1 post-op up to 15 days | |
Secondary | Number of events with mild serum sodium overcorrection | Serum sodium overcorrection > 5mmol/L*24hrs | Day 1 post-op up to 15 days | |
Secondary | Number of events with severe serum sodium overcorrection | Serum sodium overcorrection > 10mmol/L*24hrs | Day 1 post-op up to 15 days | |
Secondary | Number of days in the hospital | Duration of hospital stay | Up to 1 month |
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