Saline Infusion Test in Hyponatremia

NCT06498856 | Not Yet Recruiting

• 1 other identifier: 23/12081
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Observational study of biochemical volume biomarker levels in response to a standardized intravenous isotonic saline infusion in patients with hyponatremia.

Conditions

Hyponatremia

Keywords

Arginine vasopressin; Copeptin; Antidiuretic hormone; Saline infusion test; Fluid- and volume regulation; Renin; Aldosterone

Outcome Measures

Primary Outcomes (1)

• Copeptin plasma levels

  Changes in copeptin levels in response to isotonic saline infusion

  240 minutes

Study Arms (1)

Adult patients with hypoosmolar hyponatremia

Patients admitted to hospital with hypo-osmolar hyponatremia with uncertain primary cause. Eligible patients will receive a standardized intravenous infusion of isotonic saline.

Other: Isotonic saline infusion

Interventions

Isotonic saline infusion OTHER

Volume expansion with one liter of isotonic saline intravenously over two hours.

Adult patients with hypoosmolar hyponatremia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to hospital with hyponatremia.

You may qualify if:

• Plasma sodium 120-130 mmol/L
• Effective osmolality (2 x plasma sodium + plasma glucose) \< 275 milliosmol/L
• Age \> 18 years

You may not qualify if:

• Intensive care unit (ICU) admission
• Adequate sodium correction rate: \> 4 mmol/L last 24 hours
• Primary polydipsia: urine osmolality \< 100 mOsm/L
• Hypertonic saline therapy
• Adrenal insufficiency
• Severe heart failure: ejection fraction \< 35 % or clinical suspicion of decompensated heart failure
• Ascites grade 3 (marked abdominal distention and discomfort)
• Chronic renal failure stage 4 or 5: estimated glomerular filtration rate \< 30
• Failure to submit informed consent

Sponsors & Collaborators

• University Hospital, Akershus: lead
• Hormone Laboratory, Aker University Hospital, Oslo, Norway: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and urine samples

MeSH Terms

Conditions

Hyponatremia; Diabetes Insipidus

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• Jacob A Winther, MD,PHD

  University Hospital, Akershus

  STUDY DIRECTOR

Central Study Contacts

Kaja Grønning, MD

CONTACT

67960000; Kaja.Gronning@ahus.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Endocrinology department

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 12, 2024
• Study Start: July 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 12, 2024

Record last verified: 2024-07