Congenital Heart Disease. Congenital malformations of cardiac chambers and connections
Conditions
Interventions
Intervention 1: Intervention group: In group (B), the Del-Nido cardioplegia solution will enter the extracorporeal circulation after suctioning at the end of surgery and will enter the systemic circu
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
5 Months to 5 Years
Inclusion criteria
Inclusion criteria: All children with a weight of 5 to 18 kg undergoing heart surgery for congenital defects.
Exclusion criteria
Exclusion criteria: Absence of written parental consent to enter the study presence of coagulation disorders before surgery liver dysfunction with an increase in SGOT or SGPT more than 1.5 times the baseline level before surgery presence of congenital kidney diseases death of the child during surgery need To perform complex surgery children with RACHS score higher than 2 occurrence of fever resistant to treatment after surgery occurrence of confirmed sepsis after surgery until the time of admission to ICU procalcitonin level greater than 0.5 ng/dL with signs of infection CPB or transverse aortic clamp time more than 120 minutes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in serum osmolarity considering serum levels of sodium, glucose and blood urea nitrogen. Timepoint: - Serum glucose, blood urea nitrogen, and sodium levels of children will be measured and recorded before entering the operating room (T1), after entering the ICU (T2), and 24 hours after entering the ICU (T3). .- The serum creatinine level of children will be measured and recorded before entering the operating room (T1), after entering the ICU (T2), and 24 hours after entering the ICU (T3). Method of measurement: Preparation of blood test samples at specified times. | — |
Secondary
| Measure | Time frame |
|---|---|
| The time of separation from mechanical ventilation, the occurrence of neurological complications, the probable mortality index of children, the occurrence of acute renal failure (AKI). Timepoint: Other patient information including: age, sex, weight, height, disease diagnosis, cardioplegia volume, aortic transverse clamp time, and cardiopulmonary bypass (CPB) time will be recorded.In case of dysrhythmia in children, the type of dysrhythmia will be recorded until admission to ICU.Postoperative morbidities including neurological complications, dysrhythmias, pulmonary congestion, pneumonia, and acute kidney injury will be recorded. Neurological complications include: Seizures, coma, brain edema or brain damage based on the data obtained from specialized imaging. Acute kidney injury is based on an increase of more than 50% in serum creatinine level or an increase in serum creatinine by 0.3 mg/dL will be defined as the baseline.The length of stay in the ICU will be recorded.Mortality of patients will be recorded in two groups. Method of measurement: Heart and lung monitoring, blood test sample, Glasgow Coma level of consciousness scale, chest X-ray and CT scan or magnetic resonance imaging or MRI if needed. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMahmoud Hossein Zadeh
Mashhad University of Medical Sciences
Outcome results
None listed