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Lipoic acid as adjunctive therapy for sepsis-related moderate-to-severe ARDS: a single-center, randomized, double-blind, placebo-controlled phase II trial

Lipoic acid as adjunctive therapy for sepsis-related moderate-to-severe ARDS: a single-center, randomized, double-blind, placebo-controlled phase II trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115388
Enrollment
Unknown
Registered
2025-12-25
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

acute respiratory distress syndrome (ARDS)

Interventions

Control group:Infusion of the same dose of normal saline through intravenous drip

Sponsors

Weifang People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >=18 years; 2. According to the Berlin definition—severe ARDS (PaO2/FiO2 =5 cmH2O), onset <=48 hours; 3. Assessed as sepsis-related ARDS (infection confirmed or highly suspected); 4. Currently on mechanical ventilation or expected to require mechanical ventilation within 24 hours; 5. Patient or legal representative has signed informed consent (ICU emergency consent process applicable).

Exclusion criteria

Exclusion criteria: 1. Known allergy to ALA; 2. Pregnant or breastfeeding; 3. Expected to die within 24 hours or have terminal illness; 4. Severe uncontrolled bleeding; 5. ALT/AST >5×ULN; 6. Currently receiving investigational drugs or high-dose combined antioxidant therapy that conflict with this trial; 7. Use of high-dose ALA within the past 30 days.

Design outcomes

Primary

MeasureTime frame
The absolute value and changes of PaO2/FiO2;

Secondary

MeasureTime frame
Changes in the SOFA score;The number of days the ventilator was used within 28 days;The rate of new initiation of renal replacement therapy within 28 days;Changes in inflammatory and oxidative stress biomarkers (IL-6, TNF-a, MDA, SOD, GSH);

Countries

China

Contacts

Public ContactHe Wenzheng

Weifang People's Hospital

wenzhenghe323@gmail.com+86 187 6568 3886

Outcome results

None listed

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