Neuroprotective Effect of Butylphthalide for Cardiac Arrest Patients
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorTang Ziren
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-80 years old.
Glasgow Coma Scale (GCS) scores ≤8 upon admission.
Return of Spontaneous Circulation (ROSC) ≥30min.
Signed the informed consent form.
Disqualifiers
Cardiac arrest due to irreversible causes such as trauma, poisoning, etc.
Cardiac arrest due to end-stage conditions such as advanced cancer.
Persistent cardiogenic shock that is unreversed (defined as a systolic blood pressure persistently <90mmHg despite treatment with fluid resuscitation, vasopressor agents, and inotropic medications).
Presence of pre-existing cerebrovascular disease prior to cardiac arrest or confirmed intracranial hemorrhage by CT scan following admission.
Trial design
Design model
Parallel
Treatments tested in this trial
Butylphthalide and Sodium Chloride Injection
DrugAll 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.
Saline Solution
DrugAll 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.
Treatment groups
350 Participants
are divided into 2 treatment groupsGroup A: ButylphthalideExperimental treatment 1 intervention
Group B: Saline SolutionPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Tang Ziren
Lead sponsor
Capital Medical University
Sponsor institution
Source ClinicalTrials.gov