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Randomized controlled study of Zuoximandan on cardiac insufficiency after congenital heart disease in children

Randomized controlled study of Zuoximandan on cardiac insufficiency after congenital heart disease in children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120489
Enrollment
Unknown
Registered
2026-03-16
Start date
2025-01-02
Completion date
Unknown
Last updated
2026-03-23

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

Conditions

Congenital heart disease ,insufficient heart function

Interventions

Experimental Group A:On the basis of conventional inotropic therapy, levosimendan at a maintenance dose of 0.2 ug/kg/min was administered for 24 hours.
Control Group B:Clinical routine basic cardiotonic drug therapy (such as dopamine, epinephrine, norepinephrine, milrinone, etc.). Then normal saline was given to simulate the infusion rate of levosime

Sponsors

Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 3 Years

Inclusion criteria

Inclusion criteria: 1. Knowing consent of parents or legal representatives; age 20 points.

Exclusion criteria

Exclusion criteria: 1.Severe arrhythmia; 2. Children with postoperative active bleeding; 3.Children with single ventricular physiological structure; 4.Those who are allergic to Zuoxin Mengdan and its drug components or are contraindicated; 5. The subject has any other major diagnosis or disease, and the investigator believes that these diagnosis or disease will affect the safety of the subject or the integrity of the study data; 6.The clinical data of the child is missing or missing follow-up;

Design outcomes

Primary

MeasureTime frame
Vital signs (include heart rate, blood pressure, central venous pressure);Central venous oxygen saturation, blood lactate, blood type B brain natriuretic peptide level;

Secondary

MeasureTime frame
Ejection Fraction,Tricuspid Annular Plane Systolic Excursion,Fractional Area Change,Ratio of Early Mitral Inflow Velocity to Mitral Annular Early Diastolic Velocity;

Countries

China

Contacts

Public ContactChunxiang Li

Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine

chunxiangli2008@163.com+86 21 3862 6161

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 3, 2026