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Early versus Minimally-Invasive Goal-Directed Therapy on Delayed Cerebral Ischemia and Outcome after Subarachnoid Hemorrhage

Not Applicable
Conditions
Subarachnoid hemorrhage
Registration Number
JPRN-UMIN000007509
Lead Sponsor
Research Institute for Brain and Blood Vessels-AKITA
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
150
Inclusion Criteria

Not provided

Exclusion Criteria

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Occurrence of clinical deterioration caused by DCI. Favorable outcome, defined as the proportion of patients with a modified Rankin score of 0 to 3.
Secondary Outcome Measures
NameTimeMethod
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.
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