To assess the feasibility of a randomized clinical trial on induced hypertension, and to assess whether the studied intervention is effective in increasing CBF.
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. To test whether it is feasible to perform a multicentre randomised
controlled trial on induced hypertension to
improve neurological outcome after SAH.
Secondary outcome
1. Number of patients experiencing DCI as a proportion of the total amount of
SAH patients.
2. Reasons for exlusion
3. Number of patients (in retrospective) with other causes of neurological
deterioration.
4. Difference in cerebral haemodynamics between the intervention groups.
5. Neurological condition at the start and end of the study period.
6. Neurological condition at 6 weeks after SAH.
7. Number of complications and adverse events.
Background summary
Delayed cerebral ischaemia (DCI) is a major complication after aneurysmal
subarachnoid hemorrhage (SAH). The proportion of SAH patients who develop DCI
is around 30%. DCI is associated with a 1.5-3 fold higher mortality rate. Many
centers around the world use induced hypertension, alone or in combination with
haemodilution and hypervolaemia, so called Triple-H, as standard therapy in the
treatment of DCI, but the efficacy of induced hypertension in reducing DCI is
based on case series only, and not on a randomized clinical trial.
Study objective
To assess the feasibility of a randomized clinical trial on induced
hypertension, and to assess whether the studied intervention is effective in
increasing CBF.
Study design
Multi-centre, randomized, controlled feasibility trial
Intervention
1. No intervention (reference group)
2. Induced hypertension: increasing the mean arterial pressure with a maximum
of 30 mmHg with norepinephrine. In addition, the maximum MAP in these patients
will be 140 mmHg and the maximum systolic blood pressure 240 mmHg. The maximum
dosage of norepinephrine will be 1000 ng/kg/minute. If there is no clnical
improvement observed with 24 hours after reaching one of the above mentioned
maximum values the admisnitration of norepinephrine will be tapered.
Study burden and risks
Patients are randomized between 2 treatment groups. The medical and nursing
staff in this unit has large experience with induced hypertension and the
patient will be monitored continuously. All patients will have two perfusions
CT*s
Postbus 85500
3508 GA Utrecht
Nederland
Postbus 85500
3508 GA Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
1. Admission to the hospital
2. Age 18 years or over
3. Aneurysmal SAH, demonstrated on CT-angiography or cerebral agiograph, with onset less than 72 hours before admission
4. Glascow Coma Sum Score above 8.
5. DCI (decrease of 2 GSC points or all new neurological focal deficits), diagnosed by a neurologist, neurosurgeon or intensivist within 3 hours after deterioration.
6. Informed consent
Exclusion criteria
1. Symptomatic cerebral aneurysm not yet treated by coiling or clipping
2. Co-existing severe head injury.
3. A history of a cardiac rhythm disorder, necessitating medical treatment.
4. A history of a left ventricular pump failure, necessitating medical treatment.
5. Pregnancy.
6. Known allergy for CT-contrast agents.
7. Renal failure, defined as a serum creatinine > 150 µmol/l
8. Other causes cause for neurological deterioration (see page 15 of the study protocol for the differential diagnosis)
9. Severe hypertension, defined as a MAP of 120 mmHg or higher
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL22603.041.08 |