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Low-dose Hydrocortisone for Post-cardiotomy Low Cardiac Output Syndrome in Adults: A Multicenter, Prospective, Randomized Controlled Trial

Low-dose Hydrocortisone for Post-cardiotomy Low Cardiac Output Syndrome in Adults: A Multicenter, Prospective, Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124036
Enrollment
Unknown
Registered
2026-05-06
Start date
2026-05-11
Completion date
Unknown
Last updated
2026-05-11

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

Conditions

Low Cardiac Output Syndrome

Interventions

Hydrocortisone group:The hydrocortisone group will receive 200 mg/day via continuous intravenous infusion over 24 hours for 7 consecutive days or until transfer out of the CICU, whichever occurs first

Sponsors

Northern Jiangsu People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age = 18 years; 2. Post-cardiac surgery low cardiac output syndrome (LCOS): patients who have undergone cardiac surgery and meet any of the following criteria: (1) use of mechanical circulatory support (MCS); (2) cardiac index (CI) < 2.0 L/min/m² on two consecutive measurements; (3) concurrent use of two or more inotropic agents for more than 24 hours, with at least one CI measurement < 2.0 L/min/m²; (4) use of two or more inotropic agents for more than 24 hours due to low cardiac output. 3. Signed informed consent by the patient or their legally authorized representative.

Exclusion criteria

Exclusion criteria: 1. LCOS diagnosed for more than 24 hours; 2. Sepsis present at enrollment; 3. Received corticosteroid treatment within 4 weeks prior to enrollment; 4. Received etomidate treatment prior to enrollment; 5. Immunosuppression; 6. Hypersensitivity to hydrocortisone; 7. Pregnancy or lactation.

Design outcomes

Primary

MeasureTime frame
Vasopressor-free days in both groups;

Secondary

MeasureTime frame
28-day all-cause mortality; ICU mortality and in-hospital mortality; ICU length of stay and total hospital length of stay;

Countries

China

Contacts

Public ContactJun Shao

Northern Jiangsu Peopl's Hospital

sjun1982@163.com+86 180 5106 9587

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 16, 2026