UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness of dual monitoring of cerebral oxygenation and cardiac output during hyperdynamic therapy for delayed cerebral ischemia after subarachnoid hemorrhage: A prospective study
Title of the study (Brief title)	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	Tatsushi Mutoh
Organization	Research Institute for Brain and Blood Vessels-AKITA
Division name	Department of Surgical Neurology
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	Tatsushi Mutoh
Organization	Research Institute for Brain and Blood Vessels-AKITA
Division name	Department of Surgical Neurology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 01 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
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.
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://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015521