Copeptin as a Diagnostic Marker in the Management of Neurosurgical Patients With Disturbance of Water Homeostasis

Pituitary Adenoma Clinical Trial

Official title:

Copeptin as a Diagnostic Marker in the Management of Neurosurgical Patients With Disturbance of Water Homeostasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01465672
• Other study ID #: COOP Study
• Status: Completed
• Phase: N/A
• First received: October 28, 2011
• Last updated: May 19, 2014
• Start date: October 2011
• Est. completion date: December 2013

Study information

• Verified date: May 2014
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial Summary

Water imbalance and consecutive electrolyte disturbances are common in the postoperative course of neurosurgical patients after pituitary surgery. Diabetes insipidus (DI) may complicate the postoperative course in as many as 30% of patients. Early and accurate diagnosis of water and electrolyte disturbances postoperatively is important for an adequate fluid and drug administration. However, identifying the causes is challenging/ ambiguous in clinical practice. Levels of antidiuretic hormone (ADH) might contribute to a straightforward diagnosis, though, its measurement is cumbersome. ADH is derived from a larger precursor peptide along with copeptin, which is a more stable peptide directly mirroring the production of ADH. Copeptin can be assayed readily in plasma. Aim: To investigate whether copeptin can accurately diagnose postoperative disturbances of water homeostasis (i.e. Diabetes insipidus and SIADH) in a cohort of patients undergoing intracranial tumor surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• All consecutive patients who undergo surgery for an intra- or suprasellar lesion, either by craniotomy or by transphenoidal resection.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adenoma
• Pituitary Adenoma
• Pituitary Diseases
• Pituitary Neoplasms

Locations

Country	Name	City	State
Switzerland	Kantonsspital Aarau	Aarau
Switzerland	University Hospital Basel	Basel

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Kantonsspital Aarau

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnostic accuracy, i.e. difference of copeptin levels between patients without and patients with postoperative DI, of copeptin in the diagnosis of water disturbance in neurosurgical patients	daily blood sampling will allow to diagnose DI or SIADH during hospital stay. Copeptin levels will be compared between patients with uncomplicated postoperative course and patients with development of DI or SIADH.	daily during hospital stay of the patient, on average 1 week	No