Efficacy of 8.4% sodium bicarbonate in adult patients with closed head injuries and intracranial hypertension.

Conditions: Raised intracranial pressure after severe head injury.
MedDRA version: 9.1Level: LLTClassification code 10022764Term: Intracranial hypertension

Registration Number: EUCTR2008-000219-14-GB

Lead Sponsor: orth Bristol NHS Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Adult patients in Frenchay Hospital intensive care unit who are intubated, ventilated and sedated after a severe head injury will be considered for enrollment in the trial.
They will all have continuous intracranial pressure monitoring in situ and will be at risk of raised intracranial pressure.
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

Patients aged under 16 years will be excluded.
Patients with an initial serum sodium concentration greater than 155mmol/l will be excluded.
Patients with concurrent respiratory disease that interferes with the maintenance of a normal arterial carbon dioxide tension will be excluded.
Patients with a severe pre-existing severe metabolic alkalosis will be excluded.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of the trial is to establish the ability of 8.4%sodium bicarbonate to lower intracranial pressure below 20mmHg in patients with head injuries and raised intracranial pressure (i.e intracranial pressure above 20mmHg). The duration of any fall in intracranial pressure will also be recorded.;Secondary Objective: The secondary objective of the trial is to establish the effect of 8.4%sodium bicarbonate on the acid/base status of patient's to which it is administered.;Primary end point(s): The primary end point is a fall in intracranial pressure to below 20 mmHg after treatment with 8.4%sodium bicarbonate.

Secondary Outcome Measures