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Comparison of 5% sodium chloride injection methods in the correction of hyponatremia

Comparison of efficacy of 5% sodium chloride bolus versus intravenous infusion in the correction of hyponatremia in adult patients with traumatic brain injury admitted to the intensive care unit

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20251208068246N1
Enrollment
62
Registered
2026-01-16
Start date
2026-01-12
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Trauma. Diffuse traumatic brain injury

Interventions

Intervention 1: Intervention group: The treatment group is the 5% sodium chloride intravenous bolus treatment group, which receives 50 cc twice a day. This 50 cc is given over 15 minutes. If the plasm

Sponsors

Ahvaz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patients with severe head trauma (GCS less than 8) admitted to the ICU who have a sodium level less than 125 millimoles per liter Patients older than 20 years of age Patient consent to participate in the study

Exclusion criteria

Exclusion criteria: Patients with Syndrome of inappropriate antidiuretic hormone ADH release History of surgery History of previous brain trauma History of seizures History of glucocorticoid deficiency History of thyroid disease History of pituitary surgery Patients receiving diuretics Patients with heart failure Patients with renal failure

Design outcomes

Primary

MeasureTime frame
Plasma Sodium. Timepoint: At the start of treatment and then every 4 hours for 48 hours from the initiation of treatment. Method of measurement: Electrolyte Analyzer.;Urine specific gravity. Timepoint: At the start of treatment and then every 4 hours for 48 hours from the initiation of treatment. Method of measurement: Refractometer.

Secondary

MeasureTime frame
Patient's consciousness. Timepoint: During the ICU stay. Method of measurement: Glasgow Coma Scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFereshte Amiri

Ahvaz University of Medical Sciences

amiri-f@ajums.ac.ir+98 61 3320 4536

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026