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Is hypertonic saline the medicine used for patients with head injury causing low sodium levels when compared to mannitol

Is hypertonic saline causing delayed hyponatremia in traumatic brain injury patients undergoing osmotherapy – A randomized controlled trial between hypertonic saline and mannitol - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/075262
Enrollment
160
Registered
2024-10-15
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

Health Condition 1: S061- Traumatic cerebral edema

Interventions

Intervention1: 3% NaCl: If weight less than 80 kgs, 3% NaCl administered at 100 mL Q6H x 8 doses (2 days) followed by 50 ml Q6H x 4 doses (1 day) and stopped. If weight more than 80 kgs, 3% NaCl admin

Sponsors

Christian Medical College Vellore
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients above the age of 18 years admitted following traumatic brain injury requiring osmotherapy.

Exclusion criteria

Exclusion criteria: Patients with serum sodium level less than 135 mmol/L at admission. Patients receiving diuretics or patients with renal failure – AKI/CKD. Patients who require surgery within the first 24 hours of admission. Patients who were primarily managed elsewhere. Patients with bilaterally fixed and non-reactive pupils. Pregnant women.

Design outcomes

Primary

MeasureTime frame
Incidence of delayed hyponatremia defined as serum sodium dropping below 135 mmol/L after the initiation of osmotherapy and within seven days of trauma.Timepoint: Within seven days of trauma.

Secondary

MeasureTime frame
Duration of ICU stay. Duration of hospital stay. Requirement of Fludrocortisone. Need for surgical intervention Development of hyperchloremic metabolic acidosis.Timepoint: Within seven days of trauma.

Countries

India

Contacts

Public ContactMathew Joseph

Christian Medical College, Vellore

mjoseph@cmcvellore.ac.in9894032018

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026