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A multicenter clinical study on the effect of 'warming yang', activating blood circulation therapy (Xinmailong injection) on sepsis induced myocardiac dysfunction

A multicenter clinical study on the effect of 'warming yang', activating blood circulation therapy (Xinmailong injection) on sepsis induced myocardiac dysfunction

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-16009212
Enrollment
Unknown
Registered
2016-09-17
Start date
2016-09-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

severe sepsis

Interventions

control group:Normal saline+convention medicine (SSC 2012 guaidline)
experimental group:xinmailong injection+convention medicine (SSC 2012 guaidline)

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) Diagnostic criteria for severe sepsis; (2) Syndrome of Yang Qi Deficiency and Blood Stasis Syndrome; (3) Older than 18 years old; (4) Informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with acute myocardial infarction; (2) Severe heart failure (LVEF less than 30% or IV grade of heart function); (3) Patients with severe sepsis of other syndromes, such as excess syndrome and yin deficiency syndrome etc.; (4) Patients with severe bleeding tendency or active bleeding; (5) Allergic or allergic skin test in patients with the effect of drugs; (6) Patients who could not cooperate with the study and who had died within ICU24 hours, as well as the expected short period of death (12 points; (7) Renal insufficiency, Cr > 300, or need emergency CRRT; (8) Liver dysfunction, total bilirubin >100umol/L; (9) Pregnant and lactating women; (10) Mental or legal disability; (11) Clinical trials of other drugs in the first 3 months of the trial.

Design outcomes

Primary

MeasureTime frame
Incidence of sepsis induced myocardiac dysfunction;

Secondary

MeasureTime frame
LVEF, CO, FS, LVEDD, E/A;HR, MAP, CVP;Lac, ScvO2, Pv-aCO2;BNP, cTnI;28 day mortality;SOFA score;

Countries

China

Contacts

Public ContactGuo Liheng

Guangdong Provincial Hospital of Chinese Medicine

guolh782@163.com+86 13798067825

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026