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Cardiac arrest is one of the critical illnesses that is directly life-threatening, and patients who survive cardiac arrest develop severe neurological deficits or even die. The effectiveness of drugs to improve neurological function in resuscitated brain-injured patients has been a focus of research in the field of resuscitation. Butanephthalein has an ameliorating effect on the damage of central nervous function in patients with acute ischemic stroke, and can promote the improvement of patients' neurological deficits. On this basis, the present study was designed as a multicenter, prospective randomized controlled experiment, with internationally accepted methods for assessing near-term and long-term neurological function, to determine the effectiveness of butalbital in improving neurological function after cardiac arrest, with the aim of searching for new methods and ideas to improve neurological function and prognosis after cardiac arrest.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Butylphthalide | Experimental | Butylphthalide and Sodium Chloride Injection 100ml ivgtt bid 14days |
|
| Saline Solution | Placebo Comparator | Saline Solution 100ml ivgtt bid 14days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Butylphthalide and Sodium Chloride Injection | Drug | All enrolled patients will undergo standard treatment as per international guidelines, concurrently receiving either NBP or placebo therapy. Patients in the experimental group will receive intravenous infusion of 100ml NBP injection twice daily, while patients in the control group will receive intravenous infusion of 100ml saline solution twice daily. Each patient will receive continuous medication for 14 days. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with a Cerebral Performance Category (CPC) Score of 1-2 | The primary outcome is the proportion of patients with a Cerebral Performance Category (CPC) score of 1-2 at 6months after randomization in each group. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ziren Tang, Ph.D | Contact | +86 010-85231530 | tangziren1970@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chao-Yang Hospital | Recruiting | Beijing | Beijing Municipality | 100020 | China |
All IPD that underlie results in a publication
Starting 6 months after publication
The de-identified survey data will be made available for research purposes by contacting the corresponding authors
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C027125 | 3-n-butylphthalide |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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|
| Saline Solution | Drug | All enrolled patients will undergo standard treatment as per international guidelines, concurrently receiving either NBP or placebo therapy. Patients in the experimental group will receive intravenous infusion of 100ml NBP injection twice daily, while patients in the control group will receive intravenous infusion of 100ml saline solution twice daily. Each patient will receive continuous medication for 14 days. |
|
| D017670 |
| Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |