Primary objective is: - To evaluate the effects of dehydration and subsequent rehydration on coagulation and fibrinolytic parameters.Secondary objectives are:- To evaluate whether the response of coagulation and fibrinolytic parameters to fluid…
ID
Source
Brief title
Condition
- Other condition
- Endocrine and glandular disorders NEC
Synonym
Health condition
vochthuishouding
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Coagulation and fibrinolysis activation markers: F1+2 (fragment 1+2), ETP
(endogenous thrombin potential), D-dimer, Plasminogen Activator Inhibitor-1
(PAI-1) activity.
Endothelial cell activation and platelet activation markers: von Willebrand
factor activity (vWf:C), clotting factor VIII activity (fVIII:C).
Blood coagulation time: PT.
Secondary outcome
urine osmolality, plasma osmolality, antidiuretic hormone, hematocrit.
Background summary
The therapeutic use of ADH is still under investigation. Desmopressin, a
synthetic analogue of the natural pituitary hormone ADH (DDAVP), has been
widely used in several European countries as an alternative to the use of blood
products in the treatment of von Willebrand disease and mild hemophilia A.3 It
was discovered that this drug, when administered either intranasally or
intravenously, results in a rapid two- to threefold increase in all components
of the factor VIII system. Due to this fast action, it was always believed that
DDAVP does not stimulate the production of coagulation factors, but rather a
release of pre-made factors from storage granules in the endothelial cells.4;5
Although the effects of administered DDAVP in von Willebrand disease, mild
hemophilia A and even healthy subjects on haemostasis have been the subject of
extensive investigation, the physiologic effects of fluid deprivation and
subsequent, physiologic, rise of ADH on coagulation and fibrinolysis has not
yet been investigated.
Study objective
Primary objective is:
- To evaluate the effects of dehydration and subsequent rehydration on
coagulation and fibrinolytic parameters.
Secondary objectives are:
- To evaluate whether the response of coagulation and fibrinolytic parameters
to fluid restoration is mediated by ADH.
- To evaluate whether the response of coagulation and fibrinolytic parameters
to dehydration is influenced by an coexisting infection.
Study design
Observational clinical study/pilot study.
Study burden and risks
As these patients are already admitted to the hospital with, amongst others,
serious signs of dehydration there are no additional risks when participating
in this study. The number of times that blood is taken remains the same, only
the total amount is more. Participating in this study will not change the
treatment or duration or the duration of hospital stay for these patients.
Louwesweg 6
1066 EC Amsterdam
NL
Louwesweg 6
1066 EC Amsterdam
NL
Listed location countries
Age
Inclusion criteria
a. Adults >= 18 years old.
b. Able to provide informed consent.
c. Confirmed infection of any cause (for 6 patients)
Exclusion criteria
a. Strong suspection of an infection of any cause (for 6 patients) see definition of infection
b. Primary polydipsia and diabetes insipidus.
c. Untreated thyroid and adrenal hormone abnormalities.
d. Pregnancy or puerperium.
e. Common etiologies of the syndrome of inappropriate antidiuretic hormone (SIADH); Active malignancy, inflammatory diseases (multiple sclerosis, meningitis, systemic lupus erythematosus), acquired immuno- deficiency syndrome (AIDS), infections (tuberculosis, pneumonia, empyema) (only for those 6 patients without signs of infection), cystic fibrosis, drugs (Selective serotonine reuptake inhibitors, tricyclic antidepressants, carbamazepine, clofibrate, narcotics, antipsychotic drugs, cytotoxic drugs)
f. Potentiation of AVP antidiuretic effects: desmopressin, vasopressin, oxytocin, prostaglandin synthesis inhibitors
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 | NL36961.048.11 |