European Arginine Vasopressin Deficiency [central diabetes insipidus] Study – the EU-AVP-D Study

Research summary

This observational cohort study will mainly use routinely collected data,e.g.,medical history,available laboratory blood/urine results,patient-reported health data,and documented treatment errors/complications of scheduled routine consultations and planned or emergency hospitalisations,with two data collection methods (Figure 1):  First,a retrospective & cross-sectional assessment of variables of interest from the time of study inclusion back to the time of onset and diagnosis of the condition.  Second,a prospective design assessing variables of interest from the time of inclusion up to five years of follow-up. Patients with an already established diagnosis of AVP deficiency will be assessed retrospectively and prospectively; those with newly diagnosed AVP deficiency will only be assessed prospectively Primary objective Data from this study will be mainly analysed explanatory. However,one of the main objectives of this study is to assess desmopressin-induced hyponatraemia. We hypothesise that active education on the correct use of desmopressin and alerting patients on symptoms and clinical signs of hyponatraemia will reduce the rate of desmopressin-induced hyponatremia. Therefore,the primary endpoint is to assess in a first step,desmopressin-induced hyponatremia in retrospective and to compare these data with the rate of hyponatremia in the prospective period of 5 years. Secondary objective The overall endpoints of this study are to determine: A. Demographic characteristics (age,sex,weight,height,ethnicity) B. General disease-specific characteristics,including: I. Cause and duration of AVP deficiency II. Clinical symptoms of AVP deficiency III. Radiographic findings related to AVP deficiency IV. Other diagnosed pituitary hormone deficiencies or excesses (dose and types of hormone therapies) V. Methods of diagnosing AVP deficiency VI. Current dose and type of desmopressin VII. Previous dose and type of desmopressin VIII. Use of the ‘desmopressin escape’ method IX. Blood/Urine laboratory X. Fluid and desmopressin management risk in the sub-group of patients with adipsic AVP deficiency XI. Complications directly related to the adipsic form of AVP deficiency (e.g.,venous thrombo-embolism) XII. Disease course in the sub-group of patients with transient AVP deficiency C. In- and out-hospital complications since diagnosis I. Number and setting (in- vs out-hospital) of laboratory-confirmed hyponatraemic episodes II. Course of plasma sodium levels during hyponatraemic episodes III. Involvement of endocrine specialist during hyponatraemic episodes IV. Complications related to hyponatraemic episodes (e.g.,osmotic demyelination syndrome) V. Number and setting (in- vs out-hospital) of laboratory-confirmed hypernatraemic episodes VI. Course of plasma sodium levels during hypernatraemic episodes VII. Involvement of endocrine specialist during hypernatraemic episodes VIII. Involvement of endocrine specialist during hospitalisations for any medical and surgical reasons (planned or emergency hospitalisations) IX. Treatment errors during hospitalisations (e.g.,wrong fluid management,missed prescription of desmopressin,wrong treatment/medication due to confusion etc.) D. Patients’ perspective on awareness and knowledge in the medical team I. Patient-reported treatment errors during hospitalisations II. Patient-reported effects of the name-change of the condition E. Co-morbidities,including: I. Current endocrine,cardiovascular,respiratory,gastrointestinal,haematological/oncological,renal,urogenital,musculoskeletal,dermatological,and neurological diseases F. Psychological co-morbidities,quality of life,and subjective assessment of disease control (usually not included in clinical routine) I. Current and previously diagnosed psychological conditions (type,treatment,duration) II. Assessment of subjective symptom control using standardised questions III. Disease control and Quality of Life by using the Nagasaki Diabetes Insipidus Questionnaire (NDI-QoL) IV. Disease control and Quality of Life by using the Posterior-Pituitary Quality of Life Questionnaire (PP-QoL) V. Anxiety Levels assessed by using the State-Trait Anxiety Inventory (STAI) VI. Alexithymia by using the Toronto Alexithymia Scale (TAS-20) VII. Depression by using the Becks’ Depression Inventory II (BDI-II) G. Gynaecological and obstetric difficulties (only in female patients) I. Number of children born before and after the onset of the disease II. Route of delivery (vaginal birth vs caesarean section [primary planned or secondary due to intra-partum complications]) III. Need for augmentation therapies during delivery (intravenous oxytocin or prostaglandin) IV. Post-partum complications and difficulties (e.g.,depression,haemorrhage,breastfeeding difficulties) V. Desmopressin dose changes during pregnancy and post-partum period

Principal Investigator

Dr Aparna Pal

Contact us

Email: diabetes.research1@ouh.nhs.uk

IRAS number

343866