Nimodipine for Treating Acute Massive Cerebral Infarction
Ключові слова
Анотація
Опис
In the clinic, physicians are reluctant to use thrombolysis, Defibrase and anticoagulation therapy because of the severity of symptoms, poor prognosis, risk of hemorrhage and high fatality rate that occur with acute massive cerebral infarction. Nimodipine, as a selective Ca2+ antagonist, is highly liposoluble, effectively crosses the blood-brain barrier, selectively acts on intracranial blood vessels, and is an accepted neuroprotective agent that can be applied in the clinic. The aim of the present study is to perform a double-blind, randomized and controlled trial of the clinical efficacy and safety of nimodipine administered as an intravenous drip in the early stages of acute massive cerebral infarction.
Patients will receive nimodipine within 3 days of infarction onset. We will closely monitor the following: (1) Blood pressure and heart rate of the patient before treatment, since nimodipine is contraindicated in patients with hypotension and low heart rate. Where blood pressure is ≥ 100/80 mmHg and heart rate ≥ 60 BPM, nimodipine will be administered. (2) Speed of infusion. This should not be too fast; we suggest 1-2 drops per minute initially, increasing gradually until the drop in systolic pressure exceeds 10 mmHg. The average drip speed should be 6-8 drops/minute, and the fastest drip speed 10 drops/minute. (3) During the infusion, physicians should monitor adverse reactions such as headache, dizziness, flushing or sweating. If any occur, the infusion speed must be reduced. If the patients remain uncomfortable, nimodipine should be withdrawn. (4) Liver and kidney function should be monitored throughout nimodipine administration.
Although nimodipine is relatively safe, there is still a risk of some adverse effects, such as cardiovascular system reactions (blood pressure decreases, bradycardia, angina, and atrioventricular block), headache, dizziness, edema, and liver and kidney dysfunction. It is necessary to determine the optimal therapeutic time window and dose of nimodipine in multi-center, large-scale clinical trials.
Дати
| Востаннє перевірено: | 03/31/2018 |
| Перший поданий: | 09/21/2014 |
| Орієнтовна реєстрація подана: | 09/22/2014 |
| Опубліковано вперше: | 09/24/2014 |
| Останнє оновлення надіслано: | 04/27/2018 |
| Останнє оновлення опубліковано: | 04/30/2018 |
| Фактична дата початку навчання: | 09/30/2014 |
| Розрахункова дата первинного завершення: | 08/31/2015 |
| Розрахункова дата завершення дослідження: | 08/31/2015 |
Стан або захворювання
Втручання / лікування
Drug: Nimodipine
Drug: Saline + citicoline
Фаза
Групи рук
| Рука | Втручання / лікування |
|---|---|
| Experimental: Saline + citicoline The control group will receive physiological saline + citicoline 2.0 g, once a day, via intravenous drip, for 10 consecutive days. Patients will receive additional drugs to treat dehydration, prevent infection and upper gastrointestinal bleeding, and maintain water and electrolyte balance. Patients with complications will receive symptomatic treatment. | Drug: Saline + citicoline physiological saline + citicoline 2.0 g, once a day, via intravenous drip, for 10 consecutive days. |
| Experimental: Nimodipine The treatment group will receive 10 mg of nimodipine in 500 ml of physiological saline via intravenous drip, at a rate of 1-2 drops per minute initially, increasing gradually until systolic pressure decreases by 10 mmHg. Maximum drip speed is 10 drops/minute, administered once a day for 7 consecutive days. The nimodipine must be kept in the dark. Blood pressure and heart rate will be monitored throughout the administration period.
Patients in control group will receive additional drugs to treat dehydration, prevent infection and upper gastrointestinal bleeding, and maintain water and electrolyte balance. Patients with complications will receive symptomatic treatment. | Drug: Nimodipine Jiangsu Jichuan Pharmaceutical Co., Ltd., Jiangsu Province, China |
Критерії прийнятності
| Вік, придатний для навчання | 18 Years До 18 Years |
| Стать, яка підходить для вивчення | All |
| Приймає здорових добровольців | Так |
| Критерії | Inclusion Criteria: - First onset at age ≤ 80 years, no other severe medical complications; - Clear consciousness or mild disturbance of consciousness; paralysis of upper and lower extremities on one side with grade 0-3 muscle strength in paralyzed limbs; - CT reveals early massive cerebral infarction (without cerebral hemorrhage or old infarction); - Blood pressure within, or higher than, the normal range. Exclusion Criteria: - Clinical manifestations are noticeably improved before treatment; - Disorders of consciousness, manifesting as severe lethargy or coma; - Mild neurological deficits, such as pure sensory disturbances, ataxia, dysarthria, and hemiparesis; - Severe hypotension (systolic pressure < 90 mmHg, diastolic pressure < 60 mmHg); - Heart rate < 60 BPM; sinus bradycardia; - Severe heart, brain or kidney dysfunction, or malignant tumor. |
Результат
Заходи первинного результату
1. Neurological deficits [up to 90 days]
