Septic CardiomyopathyPhase 4SHIELD TrailNCT06898723

The Preventive Effect of Shenfu Injection on Myocardial Dysfunction in Sepsis

A Phase 4 study testing Shenfu Injection in people with Septic Cardiomyopathy and Septic Shock, run by First Affiliated Hospital of Wannan Medical College at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Septic Cardiomyopathy, Septic Shock
What is being tested?: Shenfu Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 440 participants
Where: 1 siteChina
Study dates: 1 Oct 2024to 30 Sep 2026
Phase: Phase 4
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Qiancheng Xu contact

86-18297529106

qianchengxu@wnmc.edu.cn

China1 site, 1 recruiting

The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)
Wuhu, Anhui, 241001
Shengsheng Tao, 86-18315329399, taoshengsheng@yjsyy.com
Recruiting

Other trials in China

About this study

Official title: The Preventive Effect of Shenfu Injection on Myocardial Dysfunction in Sepsis: a Multicenter, Randomized Controlled Study

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:

Prevent myocardial dysfunction during septic shock
Accelerate cardiac recovery if complications occur
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.

Conditions: Septic Cardiomyopathy, Septic Shock
Being tested: Shenfu Injection
Keywords: Septic Shock, Cardiac Dysfunction, Shenfu Injection, Myocardial Protection, Randomized Controlled Trial
Medical subject headings: Shock, Septic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06898723
Study group	Role	What they receive
Shenfu Injection Group	Experimental	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 Receives: Drug: Shenfu Injection
Control Group	No intervention	Treatment will be conducted in accordance with international and Chinese guidelines for sepsis.

What is being measured

The primary outcome is the main question the study is designed to answer.

The incidence of septic cardiomyopathy
Measured: Day 7
Duration of vasopressor administration
The duration of vasopressor administration refers to the total time a patient requires vasopressor medications, measured in hours or days, to maintain blood pressure and support circulation.
Measured: 28 days

Secondary outcomes (10)

The incidence of septic cardiomyopathy
Measured: Day 3
Improvement in Sequential Organ Failure Assessment (SOFA) score
The SOFA score is used to assess and track the degree of organ dysfunction in critically ill patients. It evaluates six organ systems: respiratory, cardiovascular, hepatic, renal, coagulation, and neurological. Each organ system is scored from 0 to 4, with 0 indicating normal function and 4 indicating the most severe dysfunction. The total SOFA score ranges from 0 to 24, with higher scores indicating more severe organ dysfunction.
Measured: Day 3
Improvement in Sequential Organ Failure Assessment (SOFA) Score
The SOFA score is used to assess and track the degree of organ dysfunction in critically ill patients. It evaluates six organ systems: respiratory, cardiovascular, hepatic, renal, coagulation, and neurological. Each organ system is scored from 0 to 4, with 0 indicating normal function and 4 indicating the most severe dysfunction. The total SOFA score ranges from 0 to 24, with higher scores indicating more severe organ dysfunction.
Measured: Day 7
Fluid Balance (Total Fluid Intake and Output Measurement in Milliliters)
Fluid balance will be assessed by measuring total fluid intake and output in milliliters over a specified time frame. Intake includes oral and intravenous fluids, while output includes urine output, and drainage. The net fluid balance will be calculated as intake minus output, providing an indication of fluid status and potential fluid overload or deficit.
Measured: 3 days
Fluid Balance (Total Fluid Intake and Output Measurement in Milliliters)
Fluid balance will be assessed by measuring total fluid intake and output in milliliters over a specified time frame. Intake includes oral and intravenous fluids, while output includes urine output, and drainage. The net fluid balance will be calculated as intake minus output, providing an indication of fluid status and potential fluid overload or deficit.
Measured: 7 days
Duration of mechanical ventilation
The duration of mechanical ventilation is the total time a patient is on a ventilator, measured from initiation to extubation or removal. It reflects the severity of respiratory failure and recovery progress.
Measured: 28 days
Length of Intensive Care Unit(ICU) stay
The length of ICU stay refers to the total duration a patient spends in the Intensive Care Unit, measured in days. It indicates the severity of the patient's condition and recovery progress.
Measured: 28 days
Length of hospital stay
The length of hospital stay refers to the total duration a patient remains in the hospital, measured in days, from admission to discharge. It reflects the overall recovery time and treatment needs.
Measured: 28 days
28-day mortality rate
The 28-day mortality rate refers to the percentage of patients who die within 28 days of admission, including those who are classified as deceased due to withdrawal of treatment or discharge against medical advice.
Measured: 28 days
7-day mortality rate
The 7-day mortality rate refers to the percentage of patients who die within 7 days of admission, including those who are classified as deceased due to withdrawal of treatment or discharge against medical advice.
Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 202430 Sep 2026

First posted27 Mar 2025
Study start1 Oct 2024
Primary completion30 Sep 2026 (estimated)
Study completion30 Sep 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Septic CardiomyopathyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 440 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06898723
Sponsor's protocol ID: 2024109
Acronym: SHIELD Trail
Status last verified: Mar 2025
First submitted: 15 Mar 2025
Last updated: 27 Mar 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Interested in taking part?

Qiancheng Xu

86-18297529106

qianchengxu@wnmc.edu.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Active, not recruitingObservational study
Sepsis in the ICU-II
Septic Shock, Sepsis
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Echocardiography-guided Cirrhosis and Liver Failure-Intensive Care Protocol Sepsis
Cirrhosis, Liver, Cirrhotic Cardiomyopathy
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Recombinant Human Brain Natriuretic Peptide for the Recovery Stage of Septic Shock
Sepsis-induced Cardiomyopathy, the Recovery Phase of Septic Shock
RecruitingObservational study
Diagnosis, Treatment, and Outcome Assessment of Septic Cardiomyopathy Using an Integrated Mathematical Model
Septic Cardiomyopathy

All Septic Cardiomyopathy trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Preventive Effect of Shenfu Injection on Myocardial Dysfunction in Sepsis: a Multicenter, Randomized Controlled Study
ClinicalTrials.gov ID: NCT06898723
Acronym / sponsor ID: SHIELD Trail / 2024109
Conditions: Septic Cardiomyopathy, Septic Shock
Keywords: Septic Shock, Cardiac Dysfunction, Shenfu Injection, Myocardial Protection, Randomized Controlled Trial
Phase: Phase 4
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 440 participants (estimated)
Lead sponsor: First Affiliated Hospital of Wannan Medical CollegeUniversity, hospital or other
Collaborators: Suzhou Municipal Hospital of Anhui Province, the Second of Affiliated Hospital of Wannan Medical College, Wuhu, China, Wuhu County Traditional Chinese Medicine Hospital, Wuhu first people's hospital, Wuhu City Second People's Hospital, Xuancheng People's Hospital, Tongling People's Hospital, The Second Hospital of Anhui Medical University, The Fourth Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Anhui Medical University, The Third People's Hospital of Bengbu, Fuyang people's hospital, Chaohu Hospital of Anhui Medical University, The First Affiliated Hospital of Bengbu Medical University, Guangde people's hospital, Fuyang Traditional Chinese Medicine Hospital, Taihe County Traditional Chinese Medicine Hospital
Study start: 1 Oct 2024 (actual)
Primary completion: 30 Sep 2026 (estimated)
Study completion: 30 Sep 2026 (estimated)
First posted: 27 Mar 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Prevent myocardial dysfunction during septic shock
Accelerate cardiac recovery if complications occur
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Shenfu Injection Group	Experimental	Drug: Shenfu InjectionTreatment 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
Control Group	No intervention	–Treatment will be conducted in accordance with international and Chinese guidelines for sepsis.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (8 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Shenfu InjectionThe treatment will utilize Ginseng and Aconite Injection, which primarily consists of Red Ginseng and Aconite	Drug	Shenfu Injection Group

Primary outcome

The incidence of septic cardiomyopathy
Time frame: Day 7
Duration of vasopressor administration
Time frame: 28 days
The duration of vasopressor administration refers to the total time a patient requires vasopressor medications, measured in hours or days, to maintain blood pressure and support circulation.

10 secondary outcomes

The incidence of septic cardiomyopathy
Time frame: Day 3
Improvement in Sequential Organ Failure Assessment (SOFA) score
Time frame: Day 3
Improvement in Sequential Organ Failure Assessment (SOFA) Score
Time frame: Day 7
Fluid Balance (Total Fluid Intake and Output Measurement in Milliliters)
Time frame: 3 days
Fluid Balance (Total Fluid Intake and Output Measurement in Milliliters)
Time frame: 7 days
Duration of mechanical ventilation
Time frame: 28 days
Length of Intensive Care Unit(ICU) stay
Time frame: 28 days
Length of hospital stay
Time frame: 28 days
28-day mortality rate
Time frame: 28 days
7-day mortality rate
Time frame: 7 days

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
Individual participant dataSharing planned: Yes

Related trials for Septic Cardiomyopathy

Active, not recruitingObservational study
Sepsis in the ICU-II
Septic Shock, Sepsis
Recruiting
Echocardiography-guided Cirrhosis and Liver Failure-Intensive Care Protocol Sepsis
Cirrhosis, Liver, Cirrhotic Cardiomyopathy
Not yet recruiting
Recombinant Human Brain Natriuretic Peptide for the Recovery Stage of Septic Shock
Sepsis-induced Cardiomyopathy, the Recovery Phase of Septic Shock
RecruitingObservational study
Diagnosis, Treatment, and Outcome Assessment of Septic Cardiomyopathy Using an Integrated Mathematical Model
Septic Cardiomyopathy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Qiancheng Xu contact

86-18297529106

qianchengxu@wnmc.edu.cn

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Shenfu Injection in people with Septic Cardiomyopathy and Septic Shock, run by First Affiliated Hospital of Wannan Medical College at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Qiancheng Xu (86-18297529106, qianchengxu@wnmc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of septic cardiomyopathy (time frame: Day 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06898723.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.