The Preventive Effect of Shenfu Injection on Myocardial Dysfunction in Sepsis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2026-09-30

Brief Summary

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This study focuses on improving heart function in patients with life-threatening blood infections (septic shock). When the body fights severe infections, the heart sometimes struggles to pump blood effectively, which can lead to dangerous complications. Current treatments like intravenous fluids and blood pressure medications have limitations in protecting heart function.

This multicenter clinical trial aims to evaluate whether adding Shenfu Injection - a traditional Chinese medicine preparation widely used to enhance cardiac function in cardiovascular diseases - to standard therapies can:

1. Prevent myocardial dysfunction during septic shock
2. Accelerate cardiac recovery if complications occur
3. Improve overall survival and clinical outcomes The randomized controlled design will compare therapeutic effects between two groups: one receiving standard septic shock treatment alone, and the other receiving standard treatment combined with Shenfu Injection.

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Detailed Description

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Conditions

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Septic Cardiomyopathy Septic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

In this clinical trial, in addition to the ultrasound assessors mentioned above, other members of the research team, including data analysts and study coordinators, will also be masked. These individuals will not have access to specific group assignment information during the trial to ensure the objectivity of data analysis and the reliability of the results. Furthermore, participants and their immediate family members will be informed about the basic aspects of the trial but will not be disclosed the specific treatment group assignments to minimize potential bias and influence. All randomization information will be managed by an independent randomization center to ensure the integrity of the masking process.

Study Groups

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Shenfu Injection Group

Treatment will be conducted in accordance with international and Chinese guidelines for sepsis. On this basis, Shenfu Injection will be administered at a dosage of 50-100 ml (according to the medication practices of each participating center), diluted with an equal volume of 5% glucose and infused intravenously twice a day

Group Type EXPERIMENTAL

Shenfu Injection

Intervention Type DRUG

The treatment will utilize Ginseng and Aconite Injection, which primarily consists of Red Ginseng and Aconite

Control Group

Treatment will be conducted in accordance with international and Chinese guidelines for sepsis.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Shenfu Injection

The treatment will utilize Ginseng and Aconite Injection, which primarily consists of Red Ginseng and Aconite

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 1\. Patients clinically diagnosed with septic shock must meet the diagnostic criteria of Sepsis 3.0;
* 2\. Age ≥ 18 years.

Exclusion Criteria

* 1\. Pregnant or breastfeeding women;
* 2\. Individuals with a history of allergies or known hypersensitivity to Ginseng and Aconite Injection or its components;
* 3\. Severe underlying diseases that may affect prognosis, including uncontrolled malignant tumors with multiple metastases that are unresectable, hematological disorders, cachexia, persistent active bleeding, severe malnutrition, HIV, etc.;
* 4\. Severe cardiac conditions within the last three months, including acute unstable myocardial infarction, dilated cardiomyopathy, acute coronary syndrome, acute or chronic valvular heart disease, and congestive heart failure (New York Heart Association \[NYHA\] Class IV);
* 5\. Any of the following medical procedures performed within the last three months: any form of cardiac surgery, thoracotomy, external cardiac compression, defibrillation, direct current cardioversion, or trauma;
* 6\. Use of Ginseng and Aconite Injection for less than 48 hours;
* 7\. Patients expected to die within 48 hours;
* 8\. Patients deemed unsuitable for this study by the investigator.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No