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Prospective randomized controlled study of the timing of vasopressin in children with complex right heart disease after surgery

Prospective randomized controlled study of the timing of vasopressin in children with complex right heart disease after surgery

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117002
Enrollment
Unknown
Registered
2026-01-19
Start date
2022-12-14
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

congenital heart disease

Interventions

Preventive Use Group:The measured SRVI =30, VIS>=20 within 2h, and hypotension remained after ultrasound assessment except for anatomic residual malformation and severe cardiac hypofunction (LVEF<=40%

Sponsors

Fuwai Hospital, Chinese Academy of Medical Science
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0.5 Years to 14 Years

Inclusion criteria

Inclusion criteria: To be included in the study population, the following conditions must be met at the same time: (1) children with complex right heart disease admitted to the Pediatric Surgery Center of our hospital from December 1, 2022 to December 1, 2023; (2) Specific diseases: In order to reduce the impact of disease heterogeneity on clinical outcomes, the diseases to be included in this study are common complex right heart lesions, including severe TOF and TOF DORV, PAA/VSD, and extrapulmonary stenosis; (3) The specific surgical methods were radical operation under extracorporeal circulation, palliative right ventricle-pulmonary artery connection or re-replacement of external conduit stenosis; (4) The age was between 6 months and 14 years old; (5) The parents or legal guardians of the children and the children with certain autonomy signed the informed consent voluntarily.

Exclusion criteria

Exclusion criteria: Patients with ECMO support during the operation; microemboli and ischemic purpura were found in the extremities before returning to ICU after the operation; residual cardiac malformation was found after operation; diaphragmatic paralysis was found; severe airway stenosis or malacia was found; tracheoplasty was performed at the same time of cardiac repair; severe lesions or malformations of other systems were found.Any of the above can be excluded.

Design outcomes

Primary

MeasureTime frame
Duration of Ventilator Support;Length of ICU stay;

Secondary

MeasureTime frame
Mortality and associated complication rates;Time required to reach the hemodynameic target (BP, HR, CVP);oxygen metabolism improvement;Improvement in demand for fluid volume and vasoactive-intrope medicines;

Countries

China

Contacts

Public ContactZhongyuan Lu

Fuwai Hospital, Chinese Academy of Medical Science; National Center for Cardiovascular Diseases

luzhongyuan5255029@163.com+86 138 1013 0013

Outcome results

None listed

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