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A trial of Alpha lipoic acid in the treatment of sepsis with cardiac dysfunction

A multicenter, randomized controlled trial for the efficacy and safety of Alpha lipoic acid in the treatment of sepsis with cardiac dysfunction

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060784
Enrollment
Unknown
Registered
2022-06-11
Start date
2022-09-01
Completion date
Unknown
Last updated
2023-03-26

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

Conditions

sepsis

Interventions

Group 1:Alpha lipoic acid 1200 mg/day * 7days
Group 2:saline 100 mL/day * 7days

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with sepsis according to the Guidelines for Emergency Treatment of Sepsis/Septic Shock in China 2018 and hs-cTnT more than normal, NT-proBNP > 450 ng/L (18-49 years) or > 900 ng/L (50-74 years) or > 1200 ng/L (GFR < 60 mL/min); 2. Aged 18-75 years; 3. Sign written informed consent.

Exclusion criteria

Exclusion criteria: 1. More than 72 hours after meeting the inclusion criteria; 2. Patients with previous heart disease, such as myocardial infarction, coronary heart disease, congenital heart disease, cardiomyopathy, valvular disease, cardiothoracic surgery, after CRP or electrical cardioversion; 3. There are other life-threatening diseases such as cancer, renal failure (previously dependent on dialysis), severe chronic liver damage (Child-Pugh C); 4. Expected survival time < 24 hours; 5. Known or estimated limited treatment decisions (eg. no attempt at resuscitation or mechanical ventilation/dialysis); 6. Patients who are participating in other clinical trials; 7. Pregnant or breastfeeding women; 8. Patients who are allergic to ALA or similar drugs (B vitamins), and intolerant to the recommended dosage of ALA in the past; 9. Patients use immunosuppressive drugs or treated with chemoradiotherapy.

Design outcomes

Primary

MeasureTime frame
Sequential Organ Failure Assessment;

Secondary

MeasureTime frame
all-cause death;ICU admission;all-cause death in 3 month;

Countries

China

Contacts

Public ContactChenling Yao

Zhongshan Hospital, Fudan University

yao.chenling@zs-hospital.sh.cn+86 13681972052

Outcome results

None listed

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