UMIN-CTR Clinical Trial

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

Postoperative aneurysmal subarachnoid hemorrage patients

Classification by specialty

Neurosurgery

Intensive care medicine

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Research Institute for Brain and Blood Vessels-AKITA

Institute

Department

Personal name

Organization

Akita prefecture

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2014

Year

03

Month

11

Day

URL releasing protocol

Publication of results

Partially published

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

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 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.

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