Q24.9
Conditions
Interventions
Group 1: Participants: Patients with a congenital heart defect until the age of 18 years undergoing cardiac surgery with CPB (cardiopulmonary bypass).
Group 2: Participants: Patients with a congenital
Sponsors
Klinik für Angeborene Herzfehler/ Kinderkardiologie, Deutsches Herzzentrum Berlin
Eligibility
Sex/Gender
All
Age
0 Months to 18 Years
Inclusion criteria
Inclusion criteria: Patients with congenital heart defect undergoing a cardiac surgery with or without CBP. Patients are included under the condition of the documented informed consent of legal representatives concerning minor patients and informed consent of patients concerning patients of legal age.
Exclusion criteria
Exclusion criteria: Patients - With a gestational age = 37 weeks - With immundeficiencies (e.g. microdeletionssyndrom 22q11) or syndromes (trisomie 18 and 21) - With immunosuppressive therapies - Maternal alcohol-/drug addiction during pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| During the stay on the intensive care unit, we will assess - Mechanical ventilation time (in hours) and The amount of catecholamines. After the arrival on the intensive care unit, we assess the amount of catecholamines hourly. 24 h after the operation we will calculate the maximum and mean “Vasotropic Inotropic Score” by Gaies et al: Dopamine dose (mcg/kg/min)+ Dobutamine dose (mcg/kg/min) + 100 x Epinephrine dose (mcg/kg/min + 10 x Milrinine dose (mcg/kg/min) + 10.000 x Vasopressin dose (units/kg/min) + 100 x Norepinephrine does (mcg/kg/min) - Furthermore, we will assess the duration of stay on pediatric intensive care unit References: Gaies MG, Jeffries HE, Niebler RA, Pasquali SK, Donohue JE, Yu S, Gall C, Rice TB, Thiagarajan RR. Vasoactive-inotropic score is associated with outcome after infant cardiac surgery: an analysis from the Pediatric Cardiac Critical Care Consortium and Virtual PICU System Registries. Pediatr Crit Care Med 2014;15:529-37. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary enpoints will be assessed during the whole hospital stay: - 30-day mortality - The amount of blood products (erythrocytes, thrombocytes, FFP, AT III) and volume substitution (gelafundin, sterofundin) in ml - Clinical and laboratory-chemical signs for infection and organdysfunction (bodytemperature, CRP, leukocytes, urea, creatinine, AST, ALT, CK, CK-MB, lactate, LDH) - Capillary leak syndrome, which is defined by oedema, ascites or pleural effusion and and/or a positive fluid balance exceeding >10% bodyweight during the first 72h after operation and or blood pressure instability in need of volume substitution and/or a subcutaneous-thoracic ratio (S/T) with a threshold of >12,6% calculated from a chest X-ray based on Sonntag et al. 24 to 72h after operation. The postoperative chest X-ray will be compared with the preoperative chest X-ray. References: Sonntag J, Grunert U, Stöver B, Obladen M. The clinical relevance of subcutaneous-thoracic ratio in preterm newborns as a possibility for quantification of capillary leak syndrome. Z Geburtshilfe Neonatol 2003;207:208-12. - Amount of blood products, volume substitution - Clinical and laboratory-chemical signs for infection and organdysfunction (temperature, CRP, leukocytes, urea, creatinine, AST, ALT, CK, CK-MB, lactate, LDH) - Capillary leak syndrome | — |
Countries
Germany
Contacts
Public ContactJana Krech
Klinik für Angeborene Herzfehler/ Kinderkardiologie, Deutsches Herzzentrum Berlin
Outcome results
None listed