The Efficacy of YiQiFuMai Injection as an Adjunctive Treatment for Sepsis

Sepsis Clinical Trial

Official title:

Evaluation of Efficacy of YiQiFuMai Injection as an Adjunctive Treatment for Sepsis: a Single Center Randomized Controlled Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05265130
• Other study ID #: CI2021A02908
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: February 28, 2022
• Est. completion date: October 31, 2024

Study information

• Verified date: February 2022
• Source: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Contact: An-lu Wang
• Phone: +8662835151
• Email: wwanganlu[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 YQFM is proved to be effective for treating sepsis (unpublished data).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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: October 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

Drug:
• YiQiFuMai
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.
• 0.9% Normal Saline 250ml
0.9% Normal Saline 250ml IV, about 40 drops per min.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xiyuan Hospital of China Academy of Chinese Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause Mortality [28 days after randomization]	Death from all causes at 28-days	In 28 days after randomization
Primary	Mortality in ICU and several time points	Death from all causes at ICU discharge, 7 days, and 14 days after randomization	In 14 days after randomization
Primary	The secondary infection rate in 28 days.		In 28 days after randomization
Primary	Length of stay in ICU		up to 28 days after randomization
Primary	Absolute lymphocyte count in the routine blood test (*10^9g/L)		Change from baseline at 14 days after randomization
Primary	Concentration of T cells and B cells	CD3+CD4-CD8-, CD3+CD4+CD8-, CD3+CD4-CD8+, CD3+CD4+CD8+, CD3+CD19-, CD3-CD19+, CD3+(CD16+CD56)+, CD3-(CD16+CD56)+ ,CD4+CD25+,CD4+CD25+CD127- (cells/uL)	Change from baseline at 14 days after randomization
Primary	Concentration of inflammatory cytokines	interleukin (IL) 1ß, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-17, interferon (IFN) a, IFN-?, and Tumor nuclear factor (TNF)-a. (pg/mL);	Change from baseline at 14 days after randomization
Primary	Concentration of Procalcitonin		Change from baseline at 14 days after randomization
Primary	Length of stay in hospital		up to 28 days after randomization
Secondary	Duration of mechanical ventilation (MV) in ICU		up to 28 days after randomization
Secondary	Duration of continual renal replacement therapy (CRRT) in ICU		up to 28 days after randomization
Secondary	Duration of vasopressor drugs in ICU		up to 28 days after randomization
Secondary	Duration of fluid resuscitation in ICU		up to 28 days after randomization
Secondary	Total amount of fluid resuscitation (mL) in ICU		up to 28 days after randomization
Secondary	SOFA score	Total Sequential Organ Failure Assessment (SOFA) score (0-24), higher values represent a worse outcome	Change from baseline at 14 days after randomization
Secondary	APACHEII	Acute Physiology and Chronic Health Evaluation (include Acute physiology score, APS and age and Chronic physiology score, totally 0-71 Points)	change from baseline at 7 days after randomization
Secondary	Self-Rating Anxiety Scale (SAS) score	Score range from 0 to 80, higher values represent a worse outcome	change from baseline at 28 days after randomization
Secondary	Self-Rating Depression Scale (SDS) score	Score range from 0 to 80, higher values represent a worse outcome	change from Day 7 at 28 days after randomization
Secondary	Barthel score	Score range from 0 to 100, higher values represent a better outcome	change from baseline at 28 days after randomization
Secondary	The mean artery pressure (MBP)		change from baseline at 7 days after randomization
Secondary	The worst heart rate		change from baseline at 7 days after randomization
Secondary	Concentration of serum lactate		change from baseline at 14 days after randomization
Secondary	The rate of lactate clearance	(baseline lactate-lactate)/baseline lactate	change from baseline at 14 days after randomization
Secondary	The volume of urine output		change from baseline at 14 days after randomization
Secondary	Concentration of IgM, IgG, IgE (g/L) (blood)		change from baseline at 14 days after randomization
Secondary	Concentration of complement in serum (C3 and C4) (g/L)		change from baseline at 14 days after randomization