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Evaluation of Intra-Aortic Balloon Pumping in Sepsis-Associated Cardiogenic Shock: A Multicenter Randomized Controlled Trial

Evaluation of Intra-Aortic Balloon Pumping in Sepsis-Associated Cardiogenic Shock: A Multicenter Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113320
Enrollment
Unknown
Registered
2025-11-27
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-12-01

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

Conditions

Sepsis-Associated Cardiogenic Shock

Interventions

Conventional therapy group:infection control, fluid management, vasopressors, and inotropes (according to the Surviving Sepsis Campaign 2021 Guidelines). If clinical deterioration occurs, escalation t
IABP group:conventional therapy plus IABP support

Sponsors

Zhejiang Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age 18–80 years; 2. Diagnosis of sepsis (Sepsis-3.0): infection + ?SOFA >= 2; 3. Diagnosis of cardiogenic shock, defined by: (1) Hemodynamics: cardiac index = 0.1 µg/kg/min and dobutamine >= 5 µg/kg/min; or systolic blood pressure = 0.1 µg/kg/min and dobutamine >= 5 µg/kg/min, plus LVEF = 2 mmol/L; (3) Hypovolemia excluded (CVP >= 7 mmHg).

Exclusion criteria

Exclusion criteria: 1. Acute myocardial infarction (ruled out by ECGs more than 2 hours, coronary CT, or coronary angiography); 2. Moderate to severe aortic valve insufficiency; 3. Ruptured aortic sinus aneurysm; 4. Aortic diseases such as aortic dissection, aortic aneurysm, or aortic trauma; 5. Severe peripheral vascular disease; 6. Severe active bleeding and hemorrhagic disorders; 7. End-stage disease; 8. Any other condition deemed unsuitable for this trial by the investigator.

Design outcomes

Primary

MeasureTime frame
28-day all-cause mortality;

Secondary

MeasureTime frame
Hemodynamic parameters;Duration of hemodynamic stability within each 24-hour period (defined as continuous MAP = 65 mmHg);Catecholamine index (CAI) ;Duration of catecholamine therapy;SOFA score (cardiovascular component);Inflammatory markers (CRP, PCT);Lactate levels;ICU length of stay;duration of mechanical ventilation;APACHE II score;Need for renal replacement therapy;Escalation to VA-ECMO;

Countries

China

Contacts

Public ContactXianghong Yang

Zhejiang Provincial People's Hospital

jyy623@163.com+86 571 8589 4225

Outcome results

None listed

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