Acceptance and Effect of Increased Protein Intake on the Treatment of Low Blood Sodium Levels
Résumé de l'étude
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)
Intervention étudiée
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)
Maladie en cours d'investigation
Low blood sodium levels (Hyponatremia)
(BASEC)
Patients with hyponatremia in the hospital (BASEC)
Critères d'exclusion
Severe kidney and liver dysfunction. Allergies to ingredients in the protein drinks. Severe uncontrolled diabetes mellitus / hypothyroidism / adrenal insufficiency. (BASEC)
Lieu de l’étude
Bâle
(BASEC)
Sponsor
Mirjam Christ-Crain
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Mirjam Chirst-Crain
+4161 265 25 25
mirjam.christ-crain@clutterusb.chUniversity Hospital Basel
(BASEC)
Informations générales
Universittsspital Basel
+41 61 328 70 80+41 61 328 70 80
mirjam.christ-crain@clutterusb.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Date d'approbation du comité d'éthique
11.12.2024
(BASEC)
Identifiant de l'essai ICTRP
NCT06821802 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
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)
Titre académique
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)
Titre public
Protein Supplementation in Hyponatremia Due to the Syndrome of Inappropriate Antidiuresis (ICTRP)
Maladie en cours d'investigation
HyponatremiaSyndrome of Inappropriate Antidiuresis (ICTRP)
Intervention étudiée
Dietary Supplement: Moltein PURE Protein PowderBehavioral: Fluid restriction (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
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)
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Critères d'évaluation principaux et secondaires
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)
Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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 secondaires
2024-02282, kt25ChristCrain2 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT06821802 (ICTRP)
Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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