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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000013395
Receipt No. R000015521
Scientific Title Effectiveness of dual monitoring of cerebral oxygenation and cardiac output during hyperdynamic therapy for delayed cerebral ischemia after subarachnoid hemorrhage: A prospective study
Date of disclosure of the study information 2014/03/11
Last modified on 2018/09/06

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Basic information
Public title Effectiveness of dual monitoring of cerebral oxygenation and cardiac output during hyperdynamic therapy for delayed cerebral ischemia after subarachnoid hemorrhage: A prospective study
Acronym Efficacy of NIRS and CO dual monitoring in the treatment of post-SAH DCI
Scientific Title Effectiveness of dual monitoring of cerebral oxygenation and cardiac output during hyperdynamic therapy for delayed cerebral ischemia after subarachnoid hemorrhage: A prospective study
Scientific Title:Acronym Efficacy of NIRS and CO dual monitoring in the treatment of post-SAH DCI
Region
Japan

Condition
Condition Postoperative aneurysmal subarachnoid hemorrage patients
Classification by specialty
Neurosurgery Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Delayed cerebral ischemia (DCI) is one of the main causes of severe disability and death after aneurysmal subarachnoid hemorrhage (SAH). Systemic hemodynamic insufficiency such as decreased intravascular volume and low cardiac output (CO) can contribute to the development of DCI. We have performed inotropic hyperdynamic therapy for reversing DCI-related neurologic deterioration; however the precise mechanism(s) in reversing the symptoms is unclear. This prospective study aimed to determine the factors in reversing DCI by hyperdynamic therapy, using parameters derived from dual continuous hemodynamic monitoring with near infrared spectroscopy (NIRS)-based regional cerebral oxygenation (rSO2) and radial arterial waveform-based CO analysis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Occurrence of clinical deterioration caused by DCI. Favorable outcome, defined as the proportion of patients with a modified Rankin score of 0 to 3.
Key secondary outcomes Ischemic lesion retaled to DCI was assessed by cerebral blood flow using SPECT combined with 3D-SSP analysis (days 7 and 14) and MR diffusion weighted images (days 14 and 21); Therapy related complication; relationship among cerebral autoregulation index (analyzed by rSO2 and blood pressure correlation), CO change (maximum change, slope), and rSO2 uptake to relieve neurologic deficits. Fluid responsiveness using stroke volume variation, central venous pressure or pulmonary artery wedge pressure. Reliability of cardiac output and stroke volume among monitoring devices was also assessed.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The inclusion criteria were: (1) age 18 years or older, (2) initial aneurysmal subarachnoid hemorrhage (SAH), (3) pre-morbid modified Rankin Scale (mRS) score of 0 or 1, (4) aneurysm treatment performed during the first 72 hours (post-SAH day 3) after the initial hemorrhage, and (5) informed consent from the patient or the patient's legal representative. If the patient was not capable of giving informed consent and no legal representative was available, informed consent was given by an independent physician who was not involved in the patient's treatment or in conducting the trial.
Key exclusion criteria The exclusion criteria were: (1) SAH of other than aneurysmal origin, (2) no hemorrhage visible on the initial the CT scan (modified Fisher Grade 1),1 (3) concurrent participation in another interventional trial (participation in an observational trial was not considered grounds for exclusion), (4) life expectancy of less than 1 year for reasons other than the current SAH, and (5) other concomitant severe disease (e.g., intracardiac shunting, long-term cardiac arrhythmia, significant valvular heart disease, or occlusive peripheral arterial disease) that might affect treatment requirements. After screening and recruitment, patients were not enrolled in any other DCI prevention trials.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsushi Mutoh
Organization Research Institute for Brain and Blood Vessels-AKITA
Division name Department of Surgical Neurology
Zip code
Address 6-10 Senshu-Kubota-machi, Akita 010-0874, Japan
TEL 018-833-0115
Email tmutoh@tiara.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsushi Mutoh
Organization Research Institute for Brain and Blood Vessels-AKITA
Division name Department of Surgical Neurology
Zip code
Address 6-10 Senshu-Kubota-machi, Akita 010-0874, Japan
TEL 018-833-0115
Homepage URL
Email tmutoh@tiara.ocn.ne.jp

Sponsor
Institute Research Institute for Brain and Blood Vessels-AKITA
Institute
Department

Funding Source
Organization Akita prefecture
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 秋田県立脳血管研究センター(秋田県)、手稲渓仁会病院(北海道)、社会保険神戸中央病院(兵庫県)、仙台東脳神経外科病院(宮城県)

Other administrative information
Date of disclosure of the study information
2014 Year 03 Month 11 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results Strong relationship was found between peak CO slope and NIRS-based rSO2 elevation for dobutamine-induced hyperdynamic therapy, while a poor correlation was found between peak CO change and rSO2.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2008 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Preliminary results of this study were partially presented at AHA scientific sessions 2011, 2012, International stroke conference 2014 and published in Neurocritical Care. 2010;13:331-338.

Management information
Registered date
2014 Year 03 Month 11 Day
Last modified on
2018 Year 09 Month 06 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015521

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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