Induced Hypertension for Delayed Cerebral Ischaemia After Aneurysmal Subarachnoid Haemorrhage:a Feasibility Study

NCT00841633 | Terminated Phase 3

• 1 other identifier: 08-137
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the feasibility of a trial on induced hypertension to improve neurological outcome in patients with subarachnoid haemorrhage that developed the serious complication "delayed cerebral ischemia", and to assess whether induced hypertension results in improved cerebral blood flow (CBF) as measured by means of perfusion-CT.

Conditions

Cerebral Ischemia; Subarachnoid Hemorrhage

Keywords

subarachnoid hemorrhage; ischemia; vasospasm; CT; perfusion; induced hypertension; delayed cerebral ischemia

Outcome Measures

Primary Outcomes (1)

• The main study parameter will be the number of SAH patients with a diagnosis of DCI who were randomised to one of the intervention groups, in whom the intervention was adequately performed, during the duration of the trial.

  duration of the trial

Secondary Outcomes (1)

• Related to the inclusion, to the influence on cerebral haemodynamics, to the neurological condition and to adverse events

  cerebral haemodynamics: 24-36 hours, neurological condition: 6 weeks

Study Arms (2)

1

NO INTERVENTION

No induced hypertension (reference group)

2

EXPERIMENTAL

Induced hypertension with a MAP of 30 mmHg above the average MAP on the previous day; during 24-36 hours, until a perfusion CT scan has been performed

Drug: Induced hypertension with norepinephrine

Interventions

Induced hypertension with norepinephrine DRUG

Hypertension will be induced with norepinephrine. Administration of norepinephrine results in vasoconstriction, leading to an increase in blood pressure. The normal blood pressure of the patient will be calculated as the average MAP of the day before the start of the study. To achieve the intended hypertension (30 mmHg above the normal MAP for patients allocated to index group 2) in most cases a dose of 100-300 ng/kg/minute must be administered. Norepinephrine will be started on a dose of 100 ng/kg/minute, after which the dosing will be adjusted to achieve the desired blood pressure level. The maximum dose to be used in the study is 1000 ng/kg/minute. Norepinephrine is administered through the central venous catheter.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admission to the UMC Utrecht.
• Age 18 years or over.
• Aneurysmal SAH, demonstrated on CT-angiography or cerebral angiography, with onset less than 72 hours before admission.
• A level of consciousness corresponding to a Glasgow Coma Sum Score above 8, as in patients with lower Glasgow Coma Sum Scores, assessment of further deterioration may be less reliable.

You may not qualify if:

• Co-existing severe head injury.
• A history of a cardiac rhythm disorder, necessitating medical treatment.
• A history of a left ventricular pump failure, necessitating medical treatment.
• Pregnancy.
• Known allergy for CT-contrast agents.
• Renal failure, defined as a serum creatinine \> 150 µmol/l, because of the risk of contrast nephropathy.

Sponsors & Collaborators

• UMC Utrecht: lead
• Netherlands Organisation for Scientific Research: collaborator

Study Sites (1)

UMC Utrecht

Utrecht, Utrecht, 3508GA, Netherlands

Location

MeSH Terms

Conditions

Brain Ischemia; Subarachnoid Hemorrhage; Ischemia

Interventions

Norepinephrine

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr. A.J.C. Slooter

Study Record Dates

• First Submitted: October 10, 2008
• First Posted: February 11, 2009
• Study Start: February 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: October 12, 2011

Record last verified: 2011-10

Locations

NL (1)