8.4% sodium bicarbonate v 5% sodium chloride for raised intracranial pressure - a randomised controlled trial. - 8.4% sodium bicarbonate v 5% sodium chloride for raised ICP

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-012199-29-GB

Enrollment

Registered

2009-09-17

Start date

2009-07-20

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Intracranial hypertension with coma after severe head injury

Interventions

Product Name: Sodium Bicarbonate BP 8.4% Polyfusor B Pharmaceutical Form: Intravenous infusion INN or Proposed INN: 8.4% Sodium bicarbonate Concentration unit: % percent Concentration type: equal Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusions - Ventilated patients at risk of raised intracranial pressure, aged over 16 years. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusions - Age 155mmol/l, concurrent respiratory disease interfering with maintenance of a normal CO2. Pre-existing severe metabolic alkalosis.

Design outcomes

Primary

Measure	Time frame
Main Objective: The principle question relates to the effect on intracranial pressure. Is 8.4% sodium bicarbonate as effective as 5 % sodium chloride at lowering ICP in patients with raised ICP?;Secondary Objective: The secondary questions relate to the effects of each treatment on other parameters. 1)Is there a difference in effect on blood acidity between the 2 treatments? 2)Is there a difference in effect on blood sodium and osmolality? 3)What is the effect on blood pressure and cerebral perfusion pressure?;Primary end point(s): Is the treatment effective? The treatment will be considered effective if there is a drop in ICP of 10% within 10 minutes of treatment completion. How effective is the treatment? The difference between baseline ICP and the lowest IP recorded in the first hour will be calculated and compared between groups as will the time to reach threshold after a treatment.	—

Measure

Time frame

Main Objective: The principle question relates to the effect on intracranial pressure. Is 8.4% sodium bicarbonate as effective as 5 % sodium chloride at lowering ICP in patients with raised ICP?;Secondary Objective: The secondary questions relate to the effects of each treatment on other parameters. 1)Is there a difference in effect on blood acidity between the 2 treatments? 2)Is there a difference in effect on blood sodium and osmolality? 3)What is the effect on blood pressure and cerebral perfusion pressure?;Primary end point(s): Is the treatment effective? The treatment will be considered effective if there is a drop in ICP of 10% within 10 minutes of treatment completion. How effective is the treatment? The difference between baseline ICP and the lowest IP recorded in the first hour will be calculated and compared between groups as will the time to reach threshold after a treatment.

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Countries

United Kingdom

Outcome results

None listed

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