The Second Intensive Blood Pressure Reduction in Acute Ce... | NCT00716079

NCT00716079

Status Module

Name	Class
National Health and Medical Research Council, Australia	OTHER

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intensive BP lowering	Other	Management policy to lower the systolic Blood pressure (BP) to a target of 140mmHg within 1 hour of randomization and sustained for 24 hours. Sites were provided with protocols for different intravenous agents and used whichever routinely available drugs were in their hospital.	Other: Blood pressure management policies
Guideline recommended BP lowering	Other	Patients received management of BP based on the standard guidelines at the time, as published by the American Heart Association (AHA) in 2007 and 2010. The attending clinician may consider commencing BP treatment if the systolic level is greater than 180 mmHg, however and the first line treatment will be oral (including nasogastric if required) and/or transdermal routes. Should control of systolic BP not be achieved via these routes, intravenous treatment may be started until the target systolic BP of 180 mmHg is achieved.	Other: Blood pressure management policies

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood pressure management policies	Other	The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets.

Outcomes Module

Measure	Description	Time Frame
A Composite of Death or Dependency, With Dependency Being Defined by a Score of 3 to 5 on the Modified Rankin Scale (mRS)		90 days

Measure	Description	Time Frame
Death at 90 Days		90 days

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Craig Anderson, PhD	The George Institute	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic		Rochester	Minnesota	55905	United States
Regional Coordinating Centre Argentina

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18396107	Background	Anderson CS, Huang Y, Wang JG, Arima H, Neal B, Peng B, Heeley E, Skulina C, Parsons MW, Kim JS, Tao QL, Li YC, Jiang JD, Tai LW, Zhang JL, Xu E, Cheng Y, Heritier S, Morgenstern LB, Chalmers J; INTERACT Investigators. Intensive blood pressure reduction in acute cerebral haemorrhage trial (INTERACT): a randomised pilot trial. Lancet Neurol. 2008 May;7(5):391-9. doi: 10.1016/S1474-4422(08)70069-3. Epub 2008 Apr 7.
20446945

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Intensive Blood-Pressure Lowering	Intensive Blood pressure (BP) lowering therapy is given via an intravenous drip for 24 hours. The target is to reach a systolic BP <140mmHg within 1 hour. Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Intensive Blood-Pressure Lowering	Intensive Blood pressure (BP) lowering therapy is given via an intravenous drip for 24 hours. The target is to reach a systolic BP <140mmHg within 1 hour. Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets.
BG001	Guideline-Recommended Blood-Pressure Lowering	Patients will receive management of BP that is based on a standard guideline, as published by the American Heart Association (AHA). The attending clinician may consider commencing BP treatment if the systolic level is greater than 180 mmHg, however and the first line treatment will be oral (including nasogastric if required) and/or transdermal routes. Should control of systolic BP not be achieved via these routes, intravenous treatment may be started until the target systolic BP of 180 mmHg is achieved. Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020
Between 18 and 65 years

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00063.0± 13.1 BG00164.1± 12.6 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000505 BG001554 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Argentina

Title	Measurements
	BG0002 BG0012 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

A Composite of Death or Dependency, With Dependency Being Defined by a Score of 3 to 5 on the Modified Rankin Scale (mRS)

In the intensive group 12 patients were alive at 90 days but missing data on mRS (required for primary outcome), and 9 patients in the guideline group

Posted

Number

participants

90 days

ID	Title	Description
OG000	Intensive Blood-Pressure Lowering	Intensive Blood pressure (BP) lowering therapy is given via an intravenous drip for 24 hours. The target is to reach a systolic BP <140mmHg within 1 hour. Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets.
OG001	Guideline-Recommended Blood-Pressure Lowering	Patients will receive management of BP that is based on a standard guideline, as published by the American Heart Association (AHA). The attending clinician may consider commencing BP treatment if the systolic level is greater than 180 mmHg, however and the first line treatment will be oral (including nasogastric if required) and/or transdermal routes. Should control of systolic BP not be achieved via these routes, intravenous treatment may be started until the target systolic BP of 180 mmHg is achieved. Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets.

Units	Counts
Participants	OG0001382 OG0011412

Title

Denominators

Categories

Title	Measurements
	OG000719 OG001785

Secondary

Death at 90 Days

Posted

Number

participants

90 days

ID	Title	Description
OG000	Intensive Blood-Pressure Lowering	Intensive Blood pressure (BP) lowering therapy is given via an intravenous drip for 24 hours. The target is to reach a systolic BP <140mmHg within 1 hour. Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets.
OG001	Guideline-Recommended Blood-Pressure Lowering	Patients will receive management of BP that is based on a standard guideline, as published by the American Heart Association (AHA). The attending clinician may consider commencing BP treatment if the systolic level is greater than 180 mmHg, however and the first line treatment will be oral (including nasogastric if required) and/or transdermal routes. Should control of systolic BP not be achieved via these routes, intravenous treatment may be started until the target systolic BP of 180 mmHg is achieved. Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets.

Units	Counts

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Intensive Blood-Pressure Lowering	Intensive Blood pressure (BP) lowering therapy is given via an intravenous drip for 24 hours. The target is to reach a systolic BP <140mmHg within 1 hour. Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets.			324	1,399	0	0
EG001	Guideline-Recommended Blood-Pressure Lowering	Patients will receive management of BP that is based on a standard guideline, as published by the American Heart Association (AHA). The attending clinician may consider commencing BP treatment if the systolic level is greater than 180 mmHg, however and the first line treatment will be oral (including nasogastric if required) and/or transdermal routes. Should control of systolic BP not be achieved via these routes, intravenous treatment may be started until the target systolic BP of 180 mmHg is achieved. Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets.			329	1,430	0	0

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Direct effects of primary ICH event	General disorders	Non-systematic Assessment	EG000143 affected1,399 at risk EG001154 affected1,430 at risk
ICH	Vascular disorders	Non-systematic Assessment	EG0005 affected1,399 at risk EG0017 affected1,430 at risk
Ischaemic/undifferentiated stroke	Vascular disorders	Non-systematic Assessment	EG0009 affected1,399 at risk EG0018 affected1,430 at risk
Acute MI/coronary event/other	Cardiac disorders	Non-systematic Assessment	EG0005 affected1,399 at risk EG0016 affected1,430 at risk
Other vascular disease	Vascular disorders	Non-systematic Assessment	EG00015 affected1,399 at risk EG00116 affected1,430 at risk
Other cardiac disease	Cardiac disorders	Non-systematic Assessment	EG00024 affected1,399 at risk EG00127 affected1,430 at risk
Renal failure	Renal and urinary disorders	Non-systematic Assessment	EG0006 affected1,399 at risk EG00111 affected1,430 at risk
Severe hypotension	Vascular disorders	Non-systematic Assessment	EG0008 affected1,399 at risk EG00112 affected1,430 at risk
Respiratory infections	Infections and infestations	Non-systematic Assessment	EG00066 affected1,399 at risk EG00177 affected1,430 at risk
Sepsis (includes other infections)	Infections and infestations	Non-systematic Assessment	EG00026 affected1,399 at risk EG00124 affected1,430 at risk
Non-vasular medical	General disorders	Non-systematic Assessment	EG00052 affected1,399 at risk EG00150 affected1,430 at risk
Non-vasular injury (including fracture)	Injury, poisoning and procedural complications	Non-systematic Assessment	EG000107 affected1,399 at risk EG00196 affected1,430 at risk

Ancestor Terms

ID	Term
D020300	Intracranial Hemorrhages
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D006470	Hemorrhage
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Ancestor Terms

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D012457	Salicylamides
D000577	Amides
D000588	Amines
D050198	Phenoxypropanolamines
D011412	Propanolamines
D020005	Propanols
D010793	Phthalazines
D011724	Pyridazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D009574	Nitro Compounds
D007093	Imidazoles
D001393	Azoles
D004095	Dihydropyridines
D011725	Pyridines
D048288	Imidazolines
D004656	Enalapril
D004151	Dipeptides
D009842	Oligopeptides
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins

ID	Term
D002543	Cerebral Hemorrhage
D020521	Stroke
D006973	Hypertension

ID	Term
D007741	Labetalol
D008790	Metoprolol
D006830	Hydralazine
D005996	Nitroglycerin
D010646	Phentolamine
D009529	Nicardipine
C015568	urapidil
C036604	esmolol
D003000	Clonidine
D015773	Enalaprilat