Effectiveness of MG350 hemoadsorption combined with Continuous Renal Replacement Therapy (CRRT) in treating septic shock patients.

Evaluation of the efficacy of hemoadsorption using MG350 cartridge combined with Continuous Renal Replacement Therapy (CRRT) in patients with septic shock: A prospective controlled study.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12626000498392

Enrollment

Registered

2026-04-22

Start date

2026-06-01

Completion date

2026-09-30

Last updated

2026-04-27

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

Conditions

None listed

Brief summary

Tan Thanh Pharmaceutical and Trading JSC is conducting a study to evaluate the safety and efficacy of MG350 in sepsis patients. The primary objective of this trial is to determine how well the treatment is tolerated and its impact on IL6 level. Participants will be randomly assigned to either the treatment group or the control group for a period of 6 months. Clinical assessments and laboratory tests will be performed at regular intervals to monitor progress. The findings from this study are expected to provide valuable data for the further development of this therapeutic intervention.

Interventions

Description of intervention(s) / exposure: Patients receive Continuous Renal Replacement Therapy (CRRT) combined with hemoperfusion using the MG350 cartridge (Resin polymer material). Location/setting: The intervention occurs in the Surgical Intensive Care Unit (SICU). Dose: 1 MG350 cartridge per session. Frequency: 1 session per day. Duration of a single session: 4 hours of hemoperfusion, alongside 18-20 hours of CRRT. Total duration of the intervention: 1 to 3 days (maximum total of 3 cartridges/sessions per patient). Adherence assessment: Adherence to the protocol is assessed continuously by trained ICU medical staff through direct observation, review of electronic medical records, and dialysis machine logs.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients aged 18 years or older. Diagnosed with Septic Shock according to Sepsis-3 definition. Sequential Organ Failure Assessment (SOFA) score greater than or equal to 8. Vasopressor dependency: Noradrenaline dosage greater than or equal to 0.2 mcg/kg/min.

Exclusion criteria

Patients or their legal representatives refuse to participate in the study. Patients with Acute Coronary Syndrome. Patients with surgical emergencies requiring immediate intervention. Incomplete data collection

Outcome results