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

Phase 1

Conditions: Health Condition 1: G936- Cerebral edema

Registration Number: CTRI/2024/01/061156

Lead Sponsor: bharati hospital and research centre

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

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

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 <90 days.

7. Baseline ocular pathology like tumors, Grave’s disease and Sarcoidosis •

8. Previous ocular surgery

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PRIMARY OUTCOME <br/ ><br>1)Correlation of measured & estimated serum osmolality during hyperosmolar agent infusion over 6 hours from baseline. <br/ ><br> <br/ ><br>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

Secondary Outcome Measures

Name	Time	Method
SECONDARY OUTCOME <br/ ><br>1)Change in the optic nerve sheath diameter (?ONSD) at T1, T2 & T3. <br/ ><br>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