[FG] Christ-Crain Mirjam

This study aims to fill the research gap by conducting a randomized trial comparing protein supplementation and fluid restriction to standard care (no specific intervention) in preventing post-pituitary surgery hyponatremia. Participants will receive one of the three treatments from days 4 to 8 post-surgery.

This randomized open-label study will evaluate the acceptance and patient preference of a new treatment involving protein supplementation of 80g per day over five days. This will be compared to the current first-line treatment, which is fluid restriction of <1000ml per day, in hospitalized patients with hyponatremia due to SIAD.

Disruption of the hypothalamic-pituitary axis, whether due to inflammation, tumours, or head trauma, can lead to AVP deficiency (AVP-D) – formerly known as central diabetes insipidus (cDI) – characterized by polyuria and polydipsia. Desmopressin, an AVP receptor analogue, is the established treatment for AVP deficiency. 

Despite treatment, patients frequently report residual psychological symptoms, including reduced empathy, heightened anxiety, social interaction difficulties, and decreased sexual desire, substantially affecting their quality of life. Given the anatomical proximity, local disruptions of the AVP system could also disturb the oxytocin (OXT) system, resulting in an additional OXT deficiency. Our recent study utilized a novel stimulation test with MDMA, and revealed for the first time an additional OXT deficiency in patients with AVP-D. These findings may potentially explain the observed psychopathology in these patients. Although psychological changes in patients with anterior pituitary dysfunction are well-recognized and managed with respective hormonal replacement therapy, few efforts have been made to assess psychological comorbidities in patients with isolated AVP deficiency. Research on this condition is generally limited due to its rarity (currently affecting approximately 15,000 patients in Europe), especially on sexual desire and related outcomes. 

Physiological interventional study (übriger klinischer Versuch, Risk category B, no IMP). The aim of this study is to investigate plasma oxytocin in response to low-dose MDMA as a physiological stimulating agent. We do not aim to use MDMA as a medication or to develop it into a medication.

The aims of this study are to investigate whether mannitol stimulates copeptin (part 1: proof-of-concept) and whether the copeptin levels upon mannitol infusion differ in primary polydipsia and arginine vasopressin deficiency (part 2: pilot study).

Hydration status assessment, i.e. identifying whether a patient needs fluid or has too much, is one of the greatest challenges in medicine, affecting both hospitalized and ambulatory patients. Particularly in patients with heart, liver or kidney failure, therapeutic decisions and recover depend strongly on the right hydration assessment. Misjudgments may result in giving fluids to patients who do not need them or removing fluids from those who do, both of which can lead to severe complications for the patient. Accurate hydration assessment is therefore essential for guiding therapy and avoiding iatrogenic harm. However, to date, no reliable non-invasive diagnostic tool exists. Clinical evaluation remains the reference standard, even though its accuracy is limited. Many laboratory tests exist, yet all with limited application field. Over recent decades, ultrasound (US) has been investigated as a non-invasive, radiation free tool for hydration assessment, however, its diagnostic performance is impaired by a lack of standardized protocols and high operator dependency.

This project aims to put the basis for a reliable tool to guide everyday therapeutic decisions by integrating validated clinical, laboratory and US assessments. It is organized in many interconnected subprojects, designed to systematically advance hydration status assessment 

Current projects

1. Recruitment completed, manuscript under review: https://clinicaltrials.gov/study/NCT06706960
2. Pilot phase completed: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-025-08925-4

Pyroglutamated apelin-13 ([Pyr1]apelin-13, Severn Biotech Ltd., Kidderminster, UK) is an endogenous molecule, which is the most common isoform of apelin naturally present in the blood. [Pyr1]apelin-13 was already administered as systemic infusion in several physiological studies in humans. [Pyr1]apelin-13 has a half-life of a few minutes so that no effect besides the immediate effects upon its administration are expected.

Thiazides and thiazide-like diuretics are one of the five major classes of antihypertensive drugs. This study is to investigate whether urinary PGE2 concentration at baseline (prior to thiazide initiation) is associated with the development of TIH within the first four weeks of treatment.