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Induced hypertension for delayed cerebral ischaemia after aneurysmal subarachnoid haemorrhage: a feasibility study

Induced hypertension for delayed cerebral ischaemia after aneurysmal subarachnoid haemorrhage: a feasibility study - Induced hypertension for DCI after SAH

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35291
Enrollment
24
Registered
2008-07-29
Start date
2009-02-01
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

"intra-cerebral haemorrhage"

Interventions

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

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
1. To test whether it is feasible to perform a multicentre randomised controlled trial on induced hypertension to improve neurological outcome after SAH.

Secondary

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)