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

This study is currently recruiting participants.
Verified January 2013 by University Hospital, Basel, Switzerland
Sponsor:
Collaborator:
Kantonsspital Aarau
Information provided by (Responsible Party):
Mirjam Christ-Crain, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01465672
First received: October 28, 2011
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition
Pituitary Adenoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Copeptin as a Diagnostic Marker in the Management of Neurosurgical Patients With Disturbance of Water Homeostasis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • 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 [ Time Frame: daily during hospital stay of the patient, on average 1 week ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 125
Study Start Date: October 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
neurosurgical patients
Patients undergoing transphenoidal pituitary adenoma resection and patients with transcranial surgery of tumors close to the pituitary gland and hypothalamus.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing transphenoidal pituitary adenoma resection and patients with transcranial surgery of tumors close to the pituitary gland and hypothalamus.

Criteria

Inclusion Criteria:

  • All consecutive patients who undergo surgery for an intra- or suprasellar lesion, either by craniotomy or by transphenoidal resection.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01465672

Locations
Switzerland
Kantonsspital Aarau Not yet recruiting
Aarau, Switzerland
Contact: Beat Mueller, Prof Dr         happy.mueller@unibas.ch    
Principal Investigator: Beat Mueller, Prof Dr            
University Hospital Basel Recruiting
Basel, Switzerland, 4031
Contact: Mirjam Christ-Crain, Prof Dr     41 61 3287080     mirjam.christ-crain@unibas.ch    
Contact: Bettina Winzeler         bwinzeler@uhbs.ch    
Principal Investigator: Mirjam Christ-Crain, Prof Dr            
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Kantonsspital Aarau
  More Information

No publications provided

Responsible Party: Mirjam Christ-Crain, Leitende Aerztin, Prof. Dr. med., University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01465672     History of Changes
Other Study ID Numbers: COOP Study
Study First Received: October 28, 2011
Last Updated: January 15, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Basel, Switzerland:
copeptin
SIADH
Diabetes insipidus
transphenoidal pituitary adenoma resection
 pituitary adenoma
tumors close to pituitary gland
tumors close to hypothalamus

Additional relevant MeSH terms:
Pituitary Neoplasms
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Hypothalamic Neoplasms
Supratentorial Neoplasms
 Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hypothalamic Diseases
Pituitary Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013