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Tolvaptan Versus Fluid Restriction in SIADH

NCT04119206 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 334

Last updated 2019-10-08

No results posted yet for this study

Summary

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.

Conditions

  • Hyponatremia
  • Syndrome of Inappropriate ADH (SIADH) Secretion
  • Pituitary

Sponsors & Collaborators

  • University of Erlangen-Nürnberg Medical School

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-01
Primary Completion
2013-12-31
Completion
2013-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04119206 on ClinicalTrials.gov