Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04254744 |
| Other study ID # |
SIRS, cardiac surgery |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 4, 2020 |
| Est. completion date |
February 4, 2021 |
Study information
| Verified date |
March 2021 |
| Source |
Cukurova University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Systemic inflammatory response syndrome (SIRS) is frequently observed in children after
open-heart surgery and has been associated with both cardiopulmonary bypass and surgical
trauma. Children with congenital cyanotic heart disease (CCHD) have complex changes in all
blood values and clotting profiles due to chronic hypoxemia. Increased erythrocyte count
decreases plasma and coagulation factors, platelet count and function. Therefore, blood and
blood products transfusion may increase during intraoperative and postoperative periods. In
addition, durations of cardiopulmonary bypass may prolong due to the complex defects of
children with CCHD. The aim of this study is to investigate postoperative SIRS rates and risk
factors in cyanotic and acyanotic children undergoing open heart surgery for congenital heart
disease.
Description:
Systemic inflammatory response syndrome (SIRS) in adults has been defined as a non-specific
systemic inflammatory process in the absence of infection, following incidents such as
trauma, burns, pancreatitis, or major surgery. For children, age-specific SIRS criteria were
established by the International Pediatric Sepsis Consensus Conference in 2005. SIRS was
defined as presence of at least two out of four parameters, one of which must be an abnormal
temperature or leukocyte count. The two other criteria consist of either an elevated heart
rate or respiratory rate. SIRS is frequently observed in children after open-heart surgery
and has been associated with both cardiopulmonary bypass and surgical trauma. Following
cardiac surgery the pathophysiological mechanisms of SIRS involve a cytokine-mediated general
capillary leakage followed by intravascular volume depletion, generalized edema, circulatory
compromise, and altered microcirculation. The inflammatory process may further impair the
function of the lung, myocardium, kidney, liver, intestine, and brain.
Children with congenital cyanotic heart disease (CCHD) have complex changes in all blood
values and clotting profiles due to chronic hypoxemia. Increased erythrocyte count decreases
plasma and coagulation factors, platelet count and function. Therefore, blood and blood
products transfusion may increase during intraoperative and postoperative periods. In
addition, durations of cardiopulmonary bypass may prolong due to the complex defects of
children with CCHD. Previous studies have reported that the duration of CPB and the amount of
fresh frozen plasma transfusion increase SIRS formation.
The aim of this study is to investigate postoperative SIRS rates and risk factors in cyanotic
and acyanotic children undergoing open heart surgery for congenital heart disease.
Patients aged between 0-16 years and undergoing open heart surgery for cyanotic and acyanotic
congenital heart disease will be included in the study. Patients with preoperative renal
failure or hepatic disease will be excluded. Patient's age, weight, comorbidities, details of
previous operation will be recorded. Preoperative hematocrit value, white blood cell and
platelet counts, biochemical parameters (blood urea nitrogen, creatinine, electrolyte
values), diagnosis of CCHD, RACHS1 (risk adjustment for surgery for congenital heart disease)
will be recorded. In intraoperative period; operation time, CPB time, aortic cross-clamp
time, circulatory arrest time, body temperature and lowest body temperature reached during
CPB, cardioplegia amount, The ACT (activated coagulation time), urine amount will be
recorded. Intraoperative blood gas values, lactate, mean arterial pressure, glucose values
will be recorded at 30 min intervals. The amount of crystalloid and colloid, erythrocyte,
fresh frozen plasma, platelet and cryoprecipitate used in intraoperative period will be
recorded. Heparin and protamine doses administered will be recorded. Vasoactive agents
(dopamine, dobutamine, adrenaline, nitroglycerine) used in intraoperative period will be
recorded.
During the postoperative intensive care period; arterial blood gases and lactate, hematocrit,
liquid (crystalloid and colloid) and blood products administered will be monitored at 6th,
24th and 48th hours. The vasoactive agents used, the inotropic score, the amount of urine and
the use of diuretics will be recorded. Length of stay ICU, duration of mechanical
ventilation, length of stay hospital will be recorded.
Diagnosis of SIRS; in the postoperative period, the age-specific SIRS criteria determined by
the International Pediatric Sepsis Consensus Conference will be used. Patients will be
evaluated for the diagnosis of SIRS at postoperative 6th, 12th, 24th and 48th hours. SIRS
rates and risk factors in cyanotic and acyanotic patients will be determined.
