Measurement of Serum Osmolality during osmotherapy in patients with increased intracranial pressure: comparison of Measured and Calculated Serum Osmolality

COMPARISON OF MEASURED AND CALCULATED SERUM OSMOLALITY DURING OSMOTHERAPY IN PATIENTS WITH RAISED INTRACRANIAL PRESSURE. - nil

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/01/061156

Enrollment

100

Registered

2024-01-05

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

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

Conditions

Health Condition 1: G936- Cerebral edema

Interventions

Intervention1: HS bolus group: HS-bolus group will receive 300 ml bolus of 3% NaCl OVER 30 MINUTES Control Intervention1: M bolus group : M bolus group will receive 1.5g/kg IV bolus of 20% mannitol

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age ABOVE 18 YRS; 2. Patients requiring hyperosmolar therapy for treatment of raised intracranial pressure. 3. Patients presenting head injury within 8 hours with no primary osmotherapy treatment received from outside hospital

Exclusion criteria

Exclusion criteria: 1. Patients with blood sugar levels > 180-200mg/dl 2. History of alcohol consumption on admission. 3. Patients likely to undergo immediate decompression surgeries within 6 hours. 4. Patient with contraindications to osmotherapy with mannitol like Unstable hemodynamic condition, oliguric renal failure, head injuries like extradural haemorrhage 5. Serum sodium concentration below 130 mmol/L or above 155 mmol/L. 6. Terminal patients deemed by primary team to have life expectancy 7. Baseline ocular pathology like tumors, Grave’s disease and Sarcoidosis • 8. Previous ocular surgery

Design outcomes

Primary

Measure	Time frame
PRIMARY OUTCOME 1)Correlation of measured & estimated serum osmolality during hyperosmolar agent infusion over 6 hours from baseline. 2)Changes in the values measured & calculated serum osmolality, osmolal gap, urine osmolality ,serum & urine sodium concentration and haemodynamic during the infusion of experimental agents over 6 hours from baseline.Timepoint: Data will be collected immediately before the infusion of study osmotherapy agents(B0) , at 1 hour (B1), at 3 hours (B3 )and at 6 hours (B6) after the start of infusion of experimental agents	—

Measure

Time frame

PRIMARY OUTCOME 1)Correlation of measured & estimated serum osmolality during hyperosmolar agent infusion over 6 hours from baseline. 2)Changes in the values measured & calculated serum osmolality, osmolal gap, urine osmolality ,serum & urine sodium concentration and haemodynamic during the infusion of experimental agents over 6 hours from baseline.Timepoint: Data will be collected immediately before the infusion of study osmotherapy agents(B0) , at 1 hour (B1), at 3 hours (B3 )and at 6 hours (B6) after the start of infusion of experimental agents

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Secondary

Measure	Time frame
SECONDARY OUTCOME 1)Change in the optic nerve sheath diameter (?ONSD) at T1, T2 & T3. 2)Change in the mean arterial pressure before and after administration of bolus 20% mannitol and 3% hypertonic saline.Timepoint: Data will be collected immediately before the infusion of study osmotherapy agents(B0) , at 1 hour (B1), at 3 hours (B3 )and at 6 hours (B6) after the start of infusion of experimental agents	—

Measure

Time frame

SECONDARY OUTCOME 1)Change in the optic nerve sheath diameter (?ONSD) at T1, T2 & T3. 2)Change in the mean arterial pressure before and after administration of bolus 20% mannitol and 3% hypertonic saline.Timepoint: Data will be collected immediately before the infusion of study osmotherapy agents(B0) , at 1 hour (B1), at 3 hours (B3 )and at 6 hours (B6) after the start of infusion of experimental agents

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Countries

India

Contacts

Public ContactDr Ashish Nair

Bharati Vidyapeeth (DTU) University, Pune

suchetashiva@gmail.com9822051719

Outcome results

None listed

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