The Efficacy of YiQiFuMai Injection as an Adjunctive Treatment for Sepsis

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Status and phase: Not yet enrolling; Phase 4

Conditions: Sepsis

Treatments: Drug: YiQiFuMai; Drug: 0.9% Normal Saline 250ml

Study type: Interventional

Funder types: Other

Identifiers

NCT05265130

CI2021A02908

Details and patient eligibility

About

This is a prospective single center pilot randomized controlled study to assess the efficacy and safety of YiQiFuMai injection (YQFM), a widely used Chinese medicine, as an adjunctive treatment for sepsis.

Full description

Sepsis is a major clinical challenge with high mortality and morbidity worldwide. Sepsis is characterized by the dysregulated host response to an infection followed by organ dysfunction. Early sepsis mortality has diminished with advances in intensive care management and goal-directed interventions, only to surge after "recovery" from acute events, which prompts a search for sepsis-induced alterations in immune function. When suffered from sepsis, patients may have evidence of hyper-inflammation and immunosuppression. There are no high-quality evidence examining the effect of intravenous (IV) immunoglobulins or other immune modulators on the outcomes of patients with sepsis or septic shock. YiQiFuMai Injection (YQFM) is a redeveloped preparation based on the traditional Chinese medicine formula Sheng-Mai-San, which is widely used in clinical practice in China, mainly for the microcirculatory disturbance-related diseases. YQFM is proved to be effective for treating sepsis (unpublished data). And several researches reveal that YQFM attenuates acute respiratory distress syndrome and lipopolysaccharide-induced microvascular disturbance in vitro.

The purpose of this study is to explore the adjunctive treatment effect of YQFM to prognosis, immune dysfunction and organ dysfunction of sepsis.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Sepsis defined by Sepsis-3 definition
• Adult patients between the ages of 18 and 90.
• Informed consent is provided by patients or obtained by family member if patient is incapacitated.

Exclusion criteria

• Known severe allergic reaction to drugs including but not limited to YQFM.
• Pregnant patients or those who may be pregnant
• Patients with severe intracranial diseases (intracranial artery stenosis, intracranial infection, cerebral hemorrhage, cerebral infarction, brain trauma, subjects after intracranial surgery)
• Patients with extremely severe brain injury, after cardiopulmonary resuscitation, advanced malignant tumor, combined with serious primary diseases such as liver, lung, kidney and hematopoietic system, and poor prognosis;
• Autoimmune diseases, immune deficiency diseases, continuous use of immunosuppressants within the last 6 months, or organ transplants;
• Major surgery or trauma within the last 2 weeks;
• Participated in other clinical trials or took similar drugs within 1 month;
• The investigator considered that the subjects had poor compliance or other clinical, social, or family factors that were inappropriate for inclusion in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups, including a placebo group

YQFM group

Experimental group

Description:

YQFM 5.2g in 0.9% Normal Saline 250ml IV, about 40 drops per min, once a day.

Treatment:

Drug: YiQiFuMai

Placebo group

Placebo Comparator group

Description:

0.9% Normal Saline 250ml IV, about 40 drops per min.

Treatment:

Drug: 0.9% Normal Saline 250ml