We aim to investigate whether copeptin can be used as an early postoperative marker for development of DI. We will measure copeptin levels in patients just prior to and following transsphenoidal surgery to be able to investigate whether copeptin…
ID
Source
Brief title
Condition
- Hypothalamus and pituitary gland disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The difference in copeptin levels between patients who develop DI and those who
do not at several timepoints following surgery.
We will also determine a cut-off level of copeptin which can be used to predict
development of DI post surgery.
Secondary outcome
-
Background summary
Approximately 20-30% of patients develop central diabetes insipidus (DI)
following transsphenoidal surgery. DI can lead to severe morbidity and prolong
inpatient treatment. Early diagnosis of DI is thus important. Diagnosis of DI
nowadays depends on monitoring urine production and measurement of plasma
sodium and osmolality, which is labour-intensive.
Copeptin (CT-proADH) is a stable precursor of ADH and has been suggested as a
biomarker of development of DI. We hypothesize that patients who develop DI
following transsphenoidal surgery have reduced copeptin levels compared to
patients who do not develop DI.
Study objective
We aim to investigate whether copeptin can be used as an early postoperative
marker for development of DI. We will measure copeptin levels in patients just
prior to and following transsphenoidal surgery to be able to investigate
whether copeptin levels are indeed reduced in patients who develop DI. Besides
we will determine a cut-off value of copeptin for identification of DI patients
(with reduced copeptin secretion) post surgery.
Study design
Observational study, multicentre approach
Study burden and risks
This study involves 12x blood sampling (venepuncture, 12x4 ml), during
scheduled inpatient treatment and once during scheduled outpatient control, 3
weeks following surgery. Eight of 12 blood samplings will be performed during
regular blood sampling (thus require no additional venepuncture). There will be
no additional site visits, physical examinations or other tests. Participation
in this study will not influence regular treatment and no risks will be
expected from additional blood sampling.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
-adult patiënts scheduled for endoscopic transnasal pituitary surgery
Exclusion criteria
- patients <18 y old
- wilsonbekwamen
- patients with pre-existent diabetes insipidus
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL50722.018.14 |