Nervous system diseases, Subarachnoid hemorrhage
Conditions
Interventions
Twelve patients will be selected according to the inclusion and the exclusion criteria. All patients will follow the same protocol of treatment. After clinical stabilization and aneurysm occlusion, th
the measurement of lactate/pyruvate ratio by brain microdialysis will be carried out hourly. For evaluation of vasospasm, Lindegaard index will be accessed by transcranial Doppler daily. The criteria
2) three continuous days without sedation and without any alteration in the multimodality monitoring parameters, 3) permanence for seven days. The multimodality monitoring parameters to be controlled
procedure/surgery
E07.305.250.319
E01.370.350.578.937.260.850
Sponsors
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Patients of 18 to 65 years of age; have been hospitalized at Clinical Hospital, University of São Paulo Medical School within the first 72 h after the first hemorrhage; presenting Hunt and Hess grade IV or V; presenting anterior circulation aneurysm.
Exclusion criteria
Exclusion criteria: Having undergone some neurosurgical procedure at another facility (e.g. placement of an external ventricular drain) before admission at Clinical Hospital, University of São Paulo Medical School; presenting severe systemic disease; presenting either a Glasgow coma scale score of 3 or pathological posture accompanied by bilateral mydriasis with fixed pupils; unavailable information regarding level of consciousness previously to sedation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the mortality in 90 days after bleeding. Each biomarker mentioned below is a parameter. For each biomarker, a correlation analysis regarding the primary outcome will be carried out. The primary outcome regarding each of the 12 patients included in this project will be evaluated in relation to the presence or absence of altered parameter until 90 days after bleeding. For the continuously measured parameters, the parameter will be regarded as altered if the value of the parameter remained out of the normal range for more than 30 minutes at least once. For the intermittently measured parameters, a parameter will be regarded altered if at least one measurement was out of the normal range. The type of parameter, the parameters to be evaluated, the frequency of evaluation of the parameters, and the normal values of the parameters are, respectively: 1)Clinical data, body temperature, continuous measurement, altered if > or = 37.5°C; 2)Physiological data, intracranial pressure, continuous measurement, altered if > 20 mmHg; 3)Physiological data, brain temperature, continuous measurement, altered if > or = 37.5°C; 4)Physiological data, brain tissue oxygenation, continuous measurement, altered if 40; 6)Physiological data, decrease in alpha/delta ratio > 50%, as measured by electroencephalogram; 7)Physiological data, Lindegaard index (middle cerebral artery velocity / internal carotid artery velocity), daily measurement by transcranial Doppler, altered if > 6; 8)Pro-inflammatory markers in the blood (each marker will be analyzed separately as a predictor); tumor necrosis factor alpha (TNF-alpha), interferon gama (IFN-gama), interleukins (IL-1beta, IL-2, IL-6), matrix metalloproteinases (MMP-2, MMP-9), endothelin, intercellular adhesion molecule-1 (ICAM-1), C reactive protein (CPR); blood collection in the days of external ventricular drain placement and removal, and 7, 14, 21, 28 and 90 days after subarachnoid hemorrhage; normal value for each predic | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome is the functional result in 90 days after bleeding. The functional result will be referred to as good prognosis or poor prognosis. Good prognosis corresponds to a score in the modified Rankin scale equal to 0-3. Poor prognosis corresponds to a score in the modified Rankin scale equal to 4-6. The biomarkers to be analyzed as predictors of the secondary outcome are the same biomarkers used for the primary outcome. The analysis of the biomarkers regarding the secondary outcome will be the same as that regarding the primary outcome. | — |
Countries
Brazil
Contacts
Public ContactAdriano Nogueira
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Outcome results
None listed