UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013395 |
|---|---|
| Receipt number | 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 13:23:24 |
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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
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
tmutoh@tiara.ocn.ne.jp
Sponsor or person
Institute
Research Institute for Brain and Blood Vessels-AKITA
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015521
