Unique ID issued by UMIN | UMIN000007509 |
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Receipt number | R000008863 |
Scientific Title | Early versus Minimally-Invasive Goal-Directed Therapy on Delayed Cerebral Ischemia and Outcome after Subarachnoid Hemorrhage |
Date of disclosure of the study information | 2012/03/15 |
Last modified on | 2018/09/06 13:23:04 |
Early versus Minimally-Invasive Goal-Directed Therapy on Delayed Cerebral Ischemia and Outcome after Subarachnoid Hemorrhage
Early vs. Miminally-Invasive Goal-Directed Therapy and SAH Outcome
Early versus Minimally-Invasive Goal-Directed Therapy on Delayed Cerebral Ischemia and Outcome after Subarachnoid Hemorrhage
Early vs. Miminally-Invasive Goal-Directed Therapy and SAH Outcome
Japan |
Subarachnoid hemorrhage
Neurosurgery | Intensive care medicine | Adult |
Others
NO
Goal-directed fluid therapy based on cardiac output (CO) and intravascular volume is of paramount importance for preventing delayed cerebral ischemia (DCI) and improving outcome after subarachnoid hemorrhage (SAH), but questions regarding the timing of intensive management and method of monitoring still unresolved.
Others
We aimed to determine the effectiveness of early-intensive or minimally-invasive hemodynamic management guided with advanced monitoring (transpumonary thermodilution [PiCCO], uncalibrated arterial pulse contour analysis [FloTrac], and non-invasive electrical velocimetry [Aesculon]) on DCI and outcomes after SAH, compared with conventional management using a pulmonary artery(Swan-Ganz) catheter.
Confirmatory
Pragmatic
Not applicable
Occurrence of clinical deterioration caused by DCI. Favorable outcome, defined as the proportion of patients with a modified Rankin score of 0 to 3.
Ischemic lesion 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). Occurrences of cardiopulmonary complications, daily fluid intake/loss, and fluid balance calculated daily by subtracting urinary volume from total oral and intravenous intake. 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.
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
2
Treatment
Device,equipment | Maneuver |
Early-intensive group, day 0 to 14 after SAH onset
Minimally-invasive group, day 0 to 14 after SAH onset
30 | years-old | <= |
85 | years-old | >= |
Male and Female
Patients were eligible if they were treated with surgical clipping or endovascular coiling for aneurysm.
Exclusion criteria were 1) both good grade (World Federation of Neurological Surgery [WFNS] grade I) and modest bleeds (Fisher CT grade<2), 2) renal disease (creatinine level >2.0 mg/dl) that may limit appropriate fluid loading for volume therapy, and 3) severe left ventricular dysfunction (ejection fraction <35%), intracardiac shunt, permanent cardiac arrhythmia, significant valvular heart disease, or occlusive peripheral arterial disease that may cause inaccurate CO analysis or may restrict hyperdynamic therapy using inotropic pressors.
150
1st name | |
Middle name | |
Last name | Tatsushi Mutoh |
Research Institute for Brain and Blood Vessels-AKITA
Department of Surgical Neurology
6-10 Senshu-Kubota-machi, Akita 010-0874, Japan
018-833-0115
tmutoh@tiara.ocn.ne.jp
1st name | |
Middle name | |
Last name | Tatsushi Mutoh |
Research Institute for Brain and Blood Vessels-AKITA
Department of Surgical Neurology
6-10 Senshu-Kubota-machi, Akita 010-0874, Japan
018-833-0115
tmutoh@tiara.ocn.ne.jp
Research Institute for Brain and Blood Vessels-AKITA
Akita prefecture
Local Government
Japan
NO
秋田県立脳血管研究センター、手稲渓仁会病院、社会保険(現JCHO)神戸中央病院
2012 | Year | 03 | Month | 15 | Day |
Unpublished
Completed
2005 | Year | 04 | Month | 01 | Day |
2005 | Year | 04 | Month | 01 | Day |
2012 | Year | 03 | Month | 14 | Day |
2018 | Year | 09 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008863
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