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SepsisPhase 4NCT05265130

The Efficacy of YiQiFuMai Injection as an Adjunctive Treatment for Sepsis

A Phase 4 study testing YiQiFuMai and 0.9% Normal Saline 250ml in people with Sepsis, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Sepsis
What is being tested?
YiQiFuMai and 0.9% Normal Saline 250ml
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
No sites listed yet
Study dates
28 Feb 2022to 31 Oct 2024
Phase
Phase 4
Are there results?
None posted in the registry

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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

No sites are listed yet.

An-lu Wang contact

+8662835151

wwanganlu@126.com

About this study

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

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.

Read the 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.

Conditions
Sepsis
Being tested
YiQiFuMai, 0.9% Normal Saline 250ml
Medical subject headings
Sepsis

What participants receive

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

  • YiQiFuMaiDrug

    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 250mlDrug

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

Study groups in NCT05265130
Study groupRoleWhat they receive
YQFM groupExperimentalYQFM 5.2g in 0.9% Normal Saline 250ml IV, about 40 drops per min, once a day.
Receives: Drug: YiQiFuMai
Placebo groupPlacebo comparator0.9% Normal Saline 250ml IV, about 40 drops per min.
Receives: Drug: 0.9% Normal Saline 250ml

What is being measured

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

  1. All-cause Mortality [28 days after randomization]

    Death from all causes at 28-days

    Measured: In 28 days after randomization

  2. Mortality in ICU and several time points

    Death from all causes at ICU discharge, 7 days, and 14 days after randomization

    Measured: In 14 days after randomization

  3. The secondary infection rate in 28 days.

    Measured: In 28 days after randomization

  4. Length of stay in ICU

    Measured: up to 28 days after randomization

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

    Measured: Change from baseline at 14 days after randomization

  6. 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)

    Measured: Change from baseline at 14 days after randomization

  7. 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);

    Measured: Change from baseline at 14 days after randomization

  8. Concentration of Procalcitonin

    Measured: Change from baseline at 14 days after randomization

  9. Length of stay in hospital

    Measured: up to 28 days after randomization

Secondary outcomes (17)

  1. Duration of mechanical ventilation (MV) in ICU

    Measured: up to 28 days after randomization

  2. Duration of continual renal replacement therapy (CRRT) in ICU

    Measured: up to 28 days after randomization

  3. Duration of vasopressor drugs in ICU

    Measured: up to 28 days after randomization

  4. Duration of fluid resuscitation in ICU

    Measured: up to 28 days after randomization

  5. Total amount of fluid resuscitation (mL) in ICU

    Measured: up to 28 days after randomization

  6. SOFA score

    Total Sequential Organ Failure Assessment (SOFA) score (0-24), higher values represent a worse outcome

    Measured: Change from baseline at 14 days after randomization

  7. APACHEII

    Acute Physiology and Chronic Health Evaluation (include Acute physiology score, APS and age and Chronic physiology score, totally 0-71 Points)

    Measured: change from baseline at 7 days after randomization

  8. Self-Rating Anxiety Scale (SAS) score

    Score range from 0 to 80, higher values represent a worse outcome

    Measured: change from baseline at 28 days after randomization

  9. Self-Rating Depression Scale (SDS) score

    Score range from 0 to 80, higher values represent a worse outcome

    Measured: change from Day 7 at 28 days after randomization

  10. Barthel score

    Score range from 0 to 100, higher values represent a better outcome

    Measured: change from baseline at 28 days after randomization

  11. The mean artery pressure (MBP)

    Measured: change from baseline at 7 days after randomization

  12. The worst heart rate

    Measured: change from baseline at 7 days after randomization

  13. Concentration of serum lactate

    Measured: change from baseline at 14 days after randomization

  14. The rate of lactate clearance

    (baseline lactate-lactate)/baseline lactate

    Measured: change from baseline at 14 days after randomization

  15. The volume of urine output

    Measured: change from baseline at 14 days after randomization

  16. Concentration of IgM, IgG, IgE (g/L) (blood)

    Measured: change from baseline at 14 days after randomization

  17. Concentration of complement in serum (C3 and C4) (g/L)

    Measured: change from baseline at 14 days after randomization

Timeline

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

  1. First posted3 Mar 2022
  2. Study start28 Feb 2022 (estimated)
  3. Primary completion31 Jan 2024 (estimated)
  4. Study completion31 Oct 2024 (estimated)

Resources

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
Single blind
Who is masked
Participant
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05265130
Sponsor's protocol ID
CI2021A02908
Status last verified
Feb 2022
First submitted
26 Dec 2021
Last updated
3 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing YiQiFuMai and 0.9% Normal Saline 250ml in people with Sepsis, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences.

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 3 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: status not confirmed, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

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

Contact An-lu Wang (+8662835151, wwanganlu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause Mortality [28 days after randomization] (time frame: In 28 days after randomization). The study lists 9 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 NCT05265130.

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 3 Mar 2022.

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