Ischemic Cerebral Infarction
Conditions
Keywords
acute ischemic stroke,, ischemic heart disease,
Brief summary
1. Clarify novel systemic and local inflammatory mechanisms underlying the cross talk between brain and heart ischemic states, 2. Investigate the new aspects of NAC beyond traditional therapy, in cerebral and myocardial ischemic conditions, both in animal models and clinical cases.
Detailed description
The study was conducted on 121 adult acute ischemic stroke patients admitted to stroke unit; either intermediate care or intensive care, of Kasr El Ainy Medical Hospital, Cairo University. Five patients were excluded as they didn't meet our eligibility criteria. Oral form of NAC was given. Patients were divided into 4 groups: * Group I (AIS-IHD): critically ill AIS patients who had past history and / or current evidence of IHD (30 patients), Without administration of NAC (as a control group). * Group II (AIS-IHD-NAC): critically ill AIS patients who had past history and / or current evidence of ischemic heart disease (IHD) (30 patients), With nasogastric or oral administration of NAC. * Group III (AIS-NON-IHD): critically ill AIS patients who had Neither past history Nor current evidence of IHD (27 patients), Without administration of NAC (as a control group). * Group IV (AIS-NON-IHD-NAC): critically ill AIS patients who had Neither past history Nor current evidence of IHD (29 patients), With nasogastric or oral administration of NAC.
Interventions
* NAC was administered in a dose of 600 mg, every 8 hours, for 3 consecutive days, either through direct oral route, or indirectly through Ryle tube (in Ryle-feeding patients). * NAC was started shortly after hospital admission, following baseline assessment of patient. * NAC sachet form was used, so it was administrated as liquid oral solution, which was prepared from pure NAC powder, dissolved in water. * This recommended dose is within the approved therapeutic range (World Health Organization, 2021).
50 ml normal saline was administered either through direct oral route or through nasogastric tube in Ryle feeding patients.
Sponsors
Helwan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Lab Technicians
Intervention model description
* NAC was administered shortly after hospital admission, in a dose of 600 mg, every 8 hours, for 3 consecutive days, either through direct oral route, or indirectly through Ryle tube (in Ryle-feeding patients). * NAC sachet form was administrated as liquid oral solution, prepared from pure NAC powder, dissolved in water. This recommended dose is within the approved therapeutic range. * Clinical functional assessment of stroke patients was done on admission, on day 4, and before discharge, by Glasgow Coma Score, Modified Rankin Scale, and National Institutes of Health Stroke Scale. * Biochemical assessment of stroke patients was done on admission, and on day 4, by C-reactive protein, total leucocytic count, and autophagy markers (LC3B and BECN1). * Length of stay in hospital was calculated by means of total number of days between date of admission and date of discharge. * Clinical outcome (mortality and morbidity) was assessed at discharge to all patients.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age above 18 years * AIS patients admitted into stroke unit * Onset within 48 hours * Glasgow coma scale (GCS) ≥ 8 * Out of window or contraindicated for thrombolytics * Not arrested before
Exclusion criteria
* Age below 18 years * Cerebral haemorrhage * Dural sinus thrombosis * Glasgow coma scale (GCS) \< 8 * Patients received thrombolytic * Post arrest
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detect the effect of oral administration of NAC in critically ill acute ischemic stroke patients on the functional outcome. | At admission (on day 1), after 3 days (on day 4), and at discharge from hospital (up to day 30). | This outcome was assessed by evaluation of Glasgow Coma Score, the minimum and the worst = 3, and the maximum and the best = 15. It depends on assessment of Eye opening, Verbal response, Motor response. Also, evaluation of Modified Rankin Scale, for measuring the degree of disability following stroke, the maximum and the worst = 6, the minimum and the best = 0. Furthermore, evaluation of National Institutes of Health Stroke Scale (NIHSS), the most widely used functional assessment score for stroke, the maximum and the worst = 42, and the minimum and the best = 0. It depends on assessment of various clinical aspects, e.g., consciousness, orientation, vision, gaze, fascial palsy, speech, motor power, coordination, and sensation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detect the effect of oral administration of NAC in critically ill acute ischemic stroke patients on the inflammatory storm and autophagy markers. | At admission (on day 1) and after 3 days (on day 4). | Inflammatory storm and autophagy markers were evaluated by measuring serum levels of C-Reactive Protein, Total Leucocytic Count, and LC3B, BECN1, respectively. |
Countries
Egypt
Outcome results
None listed