Clinical trial NCT05265130: The Efficacy of YiQiFuMai Injection as an Adjunctive Treatment for Sepsis
Official title: Evaluation of Efficacy of YiQiFuMai Injection as an Adjunctive Treatment for Sepsis: a Single Center Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Sepsis
Lead sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2022-03-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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 YQFM is proved to be effective for treating sepsis (unpublished data).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.

Eligibility criteria: 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.

Primary outcomes:
measure: All-cause Mortality [28 days after randomization]
timeFrame: In 28 days after randomization
measure: Mortality in ICU and several time points
timeFrame: In 14 days after randomization
measure: The secondary infection rate in 28 days.
timeFrame: In 28 days after randomization
measure: Length of stay in ICU
timeFrame: up to 28 days after randomization
measure: Absolute lymphocyte count in the routine blood test (*10^9g/L)
timeFrame: Change from baseline at 14 days after randomization
measure: Concentration of T cells and B cells
timeFrame: Change from baseline at 14 days after randomization
measure: Concentration of inflammatory cytokines
timeFrame: Change from baseline at 14 days after randomization
measure: Concentration of Procalcitonin
timeFrame: Change from baseline at 14 days after randomization
measure: Length of stay in hospital
timeFrame: up to 28 days after randomization
Secondary outcomes:
measure: Duration of mechanical ventilation (MV) in ICU
timeFrame: up to 28 days after randomization
measure: Duration of continual renal replacement therapy (CRRT) in ICU
timeFrame: up to 28 days after randomization
measure: Duration of vasopressor drugs in ICU
timeFrame: up to 28 days after randomization
measure: Duration of fluid resuscitation in ICU
timeFrame: up to 28 days after randomization
measure: Total amount of fluid resuscitation (mL) in ICU
timeFrame: up to 28 days after randomization
measure: SOFA score
timeFrame: Change from baseline at 14 days after randomization
measure: APACHEII
timeFrame: change from baseline at 7 days after randomization
measure: Self-Rating Anxiety Scale (SAS) score
timeFrame: change from baseline at 28 days after randomization
measure: Self-Rating Depression Scale (SDS) score
timeFrame: change from Day 7 at 28 days after randomization
measure: Barthel score
timeFrame: change from baseline at 28 days after randomization
measure: The mean artery pressure (MBP)
timeFrame: change from baseline at 7 days after randomization
measure: The worst heart rate
timeFrame: change from baseline at 7 days after randomization
measure: Concentration of serum lactate
timeFrame: change from baseline at 14 days after randomization
measure: The rate of lactate clearance
timeFrame: change from baseline at 14 days after randomization
measure: The volume of urine output
timeFrame: change from baseline at 14 days after randomization
measure: Concentration of IgM, IgG, IgE (g/L) (blood)
timeFrame: change from baseline at 14 days after randomization
measure: Concentration of complement in serum (C3 and C4) (g/L)
timeFrame: change from baseline at 14 days after randomization
Other outcomes:
Locations:
Study officials:
affiliation: Xiyuan Hospital
name: Zhixu Yang, Prof.
role: PRINCIPAL_INVESTIGATOR
References: