Acceptance and Effect of Increased Protein Intake on the Treatment of Low Blood Sodium Levels
Descrizione riassuntiva dello studio
We are conducting this study to investigate a new treatment method for patients with low sodium levels (one of our blood salts) caused by the syndrome of inappropriate antidiuretic hormone secretion (SIAD). A low sodium level in the blood is an important and serious condition, as sodium plays a central role in the body. Sodium is crucial for regulating water balance and the function of nerves and muscles. When sodium levels are too low, it can cause various symptoms and health problems, such as concentration issues, headaches, nausea, muscle weakness, and confusion. In severe cases, hyponatremia can even lead to seizures, disturbances of consciousness, or coma. A low sodium level is particularly relevant for patients affected by SIAD. In these patients, the body retains too much water, which further lowers the sodium level in the blood. Since this can impact health status, it is important to find new and better treatment options to stabilize sodium levels. The goal is to find an effective and more pleasant alternative to fluid restriction (current standard therapy), which may lead to a long-term improvement in treatment options for SIAD patients.
(BASEC)
Intervento studiato
Protein therapy: You will receive four small protein drinks daily, each containing 20 grams of protein. You will consume these over four days. On the fifth day (or on the day of discharge if you are discharged earlier), you will come for the final examination. Fluid restriction: You will limit your fluid intake to a maximum of 1 liter per day for four days. A final examination will also be conducted on the fifth day or your discharge day.
(BASEC)
Malattie studiate
Low blood sodium levels (Hyponatremia)
(BASEC)
Patients with hyponatremia in the hospital (BASEC)
Criteri di esclusione
Severe kidney and liver dysfunction. Allergies to ingredients in the protein drinks. Severe uncontrolled diabetes mellitus / hypothyroidism / adrenal insufficiency. (BASEC)
Luogo dello studio
Basilea
(BASEC)
Sponsor
Mirjam Christ-Crain
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Mirjam Chirst-Crain
+4161 265 25 25
mirjam.christ-crain@clutterusb.chUniversity Hospital Basel
(BASEC)
Informazioni generali
Universittsspital Basel
+41 61 328 70 80+41 61 328 70 80
mirjam.christ-crain@clutterusb.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
11.12.2024
(BASEC)
ID di studio ICTRP
NCT06821802 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Effect of Protein Supplementation in Hospitalized Patients with Hyponatremia Due to the Syndrome of Inappropriate Antidiuresis – a monocentric randomised open-label active-controlled trial – the TREASUREx Trial (BASEC)
Titolo accademico
Effect of Protein Supplementation in Hospitalized Patients With Hyponatremia Due to the Syndrome of Inappropriate Antidiuresis - a Monocentric Randomized Open-label Pragmatic Active-controlled Trial - the TREASUREx Trial (ICTRP)
Titolo pubblico
Protein Supplementation in Hyponatremia Due to the Syndrome of Inappropriate Antidiuresis (ICTRP)
Malattie studiate
HyponatremiaSyndrome of Inappropriate Antidiuresis (ICTRP)
Intervento studiato
Dietary Supplement: Moltein PURE Protein PowderBehavioral: Fluid restriction (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
Inclusion Criteria:
- Adult patients with confirmed SIAD during the hospital stay or at screening, defined
by:
- Plasma sodium concentration <135 mmol/L
- Plasma osmolality <300 mOsm/kg
- Urine osmolality >100 mOsm/kg
- Urine sodium concentration >30 mmol/L
- Clinical euvolemia (no signs of hypovolemia or hypervolemia)
Exclusion Criteria:
- Lactose intolerance, milk protein allergy, soy allergy, nuts allergy, or
hypersensitivity to components of the protein supplement.
- Inborn metabolic disorders affecting carbohydrate, lipid, or protein metabolism.
- Severe symptomatic hyponatremia requiring 3% NaCl or intensive care.
- New (within the last five days) treatment with SGLT2 inhibitors, vaptans or oral
urea
- Uncontrolled severe hypothyroidism (untreated)
- Uncontrolled adrenal insufficiency (morning cortisol <150nmol/l)
- eGFR <45 mL/min/1.73 m (KDIGO G3b-5) or end-stage renal disease (dialysis)
- Severe hepatic impairment or advanced symptomatic liver disease defined as past or
current hepatic encephalopathy, liver cirrhosis Child C, or decompensated (bleeding,
jaundice, hepatorenal syndrome)
- Pregnancy, breastfeeding, or plans to become pregnant during the study.
- End-of-life care
- Lack of capacity or other reasons preventing from giving informed consent or
following study procedures (e.g., due to language problems, psychological disorders,
dementia, etc.)
- Treatment with thiazid diuretic (must be stopped at least 48 hours before inclusion)
Post-randomization Exclusion Criteria:
- Type 1 diabetes or uncontrolled type 2 diabetes (HbA1c >8.0%) (ICTRP)
non disponibile
Endpoint primari e secondari
Acceptability of Intervention Measure (AIM) questionnaire (ICTRP)
Plasma sodium levels;Estimated glomerular filtration rate (eGFR);Changes in blood electrolytes;Changes in urine electrolytes;Changes in glucose levels;Changes kidney parameters;Plasma sodium levels one day after treatment start;Endocrine parameters;General well-being;Symptoms of hyponatremia;Fluid intake;Changes in body weight;Changes in blood pressure;Changes in heart rate;Differences in clinical outcomes - length of hospital stays;Need for additional hyponatremia treatment and treatment escalation;Treatment compliance;Quality of life (EQ-5D-5L) questionnaire (ICTRP)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
Mirjam Christ-Crain, Prof. MDMirjam Christ-Crain, Prof. MDMirjam Christ-Crain, mirjam.christ-crain@usb.chmirjam.christ-crain@usb.ch, +41 61 328 70 80+41 61 328 70 80, Universittsspital Basel (ICTRP)
ID secondari
2024-02282, kt25ChristCrain2 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06821802 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile