Skip to content

A multicenter clinical study on the improvement of critical congenital heart disease with a comprehensive target-oriented extracorporeal circulation strategy

A multicenter clinical study on the improvement of critical congenital heart disease with a comprehensive target-oriented extracorporeal circulation strategy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035664
Enrollment
Unknown
Registered
2020-08-15
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-08-17

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

Conditions

Congenital tracheal stenosis

Interventions

GDP group:GDP perfusion strategy
Normal CPB group:Conventional perfusion strategy

Sponsors

Shanghai Children's Medical Center affiliated to Shanghai Jiao Tong University
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. RACHS grade 3 or above surgical children; 2. All children with congenital heart disease requiring emergency or subemergency surgery or admitted to ICU before surgery; 3. Gestational age >=32 weeks, weight >=2000g; 4. There was no serious infection before surgery; 5. No history of rescue before surgery.

Exclusion criteria

Exclusion criteria: 1. Severe multiple organ dysfunction syndrome before surgery; 2. Preoperative ECMO/VAD support; 3. Reject THE GDP strategy.

Design outcomes

Primary

MeasureTime frame
Creatinine;urine output;renal area NIRS value;Brain NIRS value;Glial fibrillary acidic protein;Troponin;positive inotropic score;cardiac output inde;ejection fraction;IL-1;IL-2;IL-6;IL-10;TNF-alpha;

Secondary

MeasureTime frame
in-hospital mortality rate;Incidence of complications;Proportion of renal replacement therap;Proportion of auxiliary circulatory use;Ventilator time;ICU time;Delayed chest closure ratio;Length of hospital stay;lactic acid;standard bicarbonate concentration;aminotransferase;Gama - glutamyl transpeptidase;

Countries

Chian

Contacts

Public ContactYinyu Yang

Shanghai Children's Medical Center affiliated to Shanghai Jiao Tong University

yangyinyu@scmc.com.cn+86 18930830953

Outcome results

None listed

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