The Efficacy of YiQiFuMai Injection as an Adjunctive Treatment for Sepsis

NCT05265130 | Unknown Phase 4 DMC

• 1 other identifier: CI2021A02908
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (9)

• All-cause Mortality [28 days after randomization]

  Death from all causes at 28-days

  In 28 days after randomization

• 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

• The secondary infection rate in 28 days.

  In 28 days after randomization

• Length of stay in ICU

  up to 28 days after randomization

• Absolute lymphocyte count in the routine blood test (*10^9g/L)

  Change from baseline at 14 days after randomization

• 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

• Concentration of inflammatory cytokines

  interleukin (IL) 1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-17, interferon (IFN) α, IFN-γ, and Tumor nuclear factor (TNF)-α. (pg/mL);

  Change from baseline at 14 days after randomization

• Concentration of Procalcitonin

  Change from baseline at 14 days after randomization

• Length of stay in hospital

  up to 28 days after randomization

Secondary Outcomes (17)

• Duration of mechanical ventilation (MV) in ICU

  up to 28 days after randomization

• Duration of continual renal replacement therapy (CRRT) in ICU

  up to 28 days after randomization

• Duration of vasopressor drugs in ICU

  up to 28 days after randomization

• Duration of fluid resuscitation in ICU

  up to 28 days after randomization

• Total amount of fluid resuscitation (mL) in ICU

  up to 28 days after randomization

Study Arms (2)

YQFM group

EXPERIMENTAL

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

Drug: YiQiFuMai

Placebo group

PLACEBO COMPARATOR

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

Drug: 0.9% Normal Saline 250ml

Interventions

YiQiFuMai DRUG

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 group

0.9% Normal Saline 250ml DRUG

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

Placebo group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Xiyuan Hospital of China Academy of Chinese Medical Sciences: lead

MeSH Terms

Conditions

Sepsis

Interventions

yi-qi-fu-mai; Saline Solution

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Zhixu Yang, Prof.

  Xiyuan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

An-lu Wang

CONTACT

+8662835151; wwanganlu@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: December 26, 2021
• First Posted: March 3, 2022
• Study Start: February 28, 2022
• Primary Completion: January 31, 2024
• Study Completion: October 31, 2024
• Last Updated: March 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share