Skip to content

A multicenter study for Traditional Chinese Medicine combined with standard bundled strategies in the treatment of sepsis

A multicenter study for Traditional Chinese Medicine combined with standard bundled strategies in the treatment of sepsis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800020435
Enrollment
Unknown
Registered
2018-12-29
Start date
2019-01-02
Completion date
Unknown
Last updated
2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sepsis

Interventions

Group 2:Shenfu injection and standard bundle therapy
Group 1:standard bundle therapy

Sponsors

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 80 years old; 2. Signing the informed consent; 3. meeting the diagnostic criteria for sepsis; 4. lactic acid was increased or hypoperfused: Serum lactic acid concentration (>4 mmol/L); The main manifestations of hypoperfusion were mental disorder, pale and cold skin, and decreased urine volume. Diagnostic criteria for sepsis: (1) Identify or suspect the presence of an infectious lesion, meeting at least one of the following criteria: The growth of pathogenic microorganisms in blood or sterile parts; the appearance of abscesses or some infected tissues; Suspected infection, supported by at least one of the following evidences: white blood cells in normal sterile sites; visceral perforation; imaging evidence of pneumonia with purulent secretions; and high-risk infection-related syndrome. (2) Secondary organ dysfunction refers to the increase of (>2) at baseline level according to the Sequential Organ Failure Assessment (SOFA) score.

Exclusion criteria

Exclusion criteria: 1) Age < 18 2) Known pregnancy 3) The following diseases should be clearly diagnosed: - Acute cerebrovascular diseases - Acute coronary syndrome - Acute pulmonary edema - Acute attack of asthma - Severe arrhythmia (as a primary disease) - epilepsy - Drug poisoning - Burn or trauma 4) Hemodynamic instability due to active gastrointestinal bleeding 5) Existence of definite immunodeficiency disorders or other definite immunosuppressive states 6) AIDS 7) Incomplete acceptance of standard cluster therapies 8) Participate in other clinical treatment studies at the same time 9) Unable to receive and complete the informed notification within 24 hours of the diagnosis of sepsis.

Design outcomes

Primary

MeasureTime frame
28-day mortality;

Secondary

MeasureTime frame
vital signs;traditional Chinese medicine Syndrome Score;Disease severity score;laboratory examinations;Adjuvant therapy;

Countries

China

Contacts

Public ContactQu Hongping

Ruijin Hospital

hongpingqu0412@hotmail.com+86 021 53305091

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 27, 2026