Heart Disease Congenital Complex Clinical Trial
Official title:
Effect of Postoperative Hydrocortisone on Cardiovascular and Respiratory Function in Neonates Undergoing Cardiopulmonary Bypass
This protocol is designed to offer insight into critical illness related corticosteroid insufficiency and steroid supplementation in neonates undergoing cardiac surgery with cardiopulmonary bypass by administering exogenous steroids in the immediate post-operative period.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | November 2013 |
| Est. primary completion date | November 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 28 Days |
| Eligibility |
Inclusion Criteria: 1. Neonate (< 28 days old) undergoing correct cardiac surgery, or infants undergoing the following surgery procedures: Norwood, Arterial Switch, Total Anomalous Pulmonary Venous Return Repair, Interrupted Aortic Arch Repair, Truncus Arteriosus Repair 2. Successfully weaned off cardiopulmonary bypass after cardiac surgery Exclusion Criteria: 1. requirement for extracorporeal membrane oxygenation (ECMO) in the operating room 2. Known immune deficiency 3. Having previously received systemic steroids (except for two routine preoperative doses) 4. A current signed Do not resuscitate (DNR) or limitation of care order 5. Current enrollment in another interventional clinical study 6. Refusal of parental consent 7. Previous diagnosis of adrenal insufficiency 8. > 28 days old at time of surgery whose repair dose not require CPB |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Alabama at Birmingham | Birmingham | Alabama |
| Lead Sponsor | Collaborator |
|---|---|
| University of Alabama at Birmingham |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of Low Cardiac Output Syndrome (LCOS) | Low Cardiac Output Syndrome (LCOS) within the first 48 hours after post-operative admission to the Pediatric Cardiac Intensive Care Unit was used as the primary outcome. This was defined as a double in inotropic support from post-operative admit, requiring Extracorporeal Membrane Oxygenation (ECMO) support, receiving Cardiopulmonary Resuscitation, or death. | first 48 hours after cardiac intensive care unit (CICU) admission post-op | No |
| Secondary | Mean Number of Days Subjects Alive and Ventilator Free | Respiratory variables include such as alive, ventilator free days at 28 days post-op will be used as secondary outcome. The mean number of days subjects were live and ventilator free up to the 28 days after surgery. | up to 28 days post op | No |
| Secondary | Hospital Length of Stay | The average length of hospital stay from the time the subject is admitted to the CICU post-op until they are discharged will be used as a secondary outcome. | Admit to CICU till hospital discharge, approximately 3 weeks | No |
| Secondary | Changes in Baseline Inflammatory Mediators | Changes in pre-op inflammatory mediators will be assessed at 0, 4, 12, 24 and 48 hours post bypass and used as a secondary outcome. | 0, 4,12, 24, and 48 hours post bypass | No |
| Secondary | Average Inotrope Score | Average inotrope score over first 48 hours after Cardiac Intensive Care Unit admission was used as a secondary outcome. Inotrope Score is calculated based on the dose of inotropes currently infusing at a given time points. The formula for calculation is as follows: Epinephrine/Norepinephrine (mcg/kg/min) dose x100, plus Dopamine/Dobutamine (mcg/kg/min) dose x 1, plus Neosynephrine (mcg/kg/min) dose x10, plus Vasopressin (units/kg/hr) [(dose x60)/10,000] = Inotrope Score. Our institution does not include Milrinone in our inotrope score calculation because every patient receives a continuous infusion in the immediate post-operative period. The higher the inotrope score the more cardiac support the patient is requiring or the worse their cardiac function is becoming. | first 48 hours post-op | No |
| Secondary | Fluid Balance | Hemodynamic variable such as total fluid balance within the first 48 hours post-op will be used as a secondary outcome. Fluid balance is a calculation of the overall fluid status for a given time period. The total input (fluid, medications, etc) that are given to a patient during a given time frame (24 hours) minus the total output (urine, stool, drainage, etc. ) that comes out of a patient during a given time frame. | 1st 48 hours post-op | No |
| Secondary | Changes in Baseline Arterial-venous Oxygen Saturation Difference | Respiratory values such as changes in baseline arterial-venous oxygen saturation difference at admission to the pediatric cardiac intensive care unit will be used as a secondary outcome. | admit to the CICU | No |
| Secondary | Time Until First Extubation | Respiratory values such as duration of intubation will be used as a secondary outcome. | Until discharge from hospital, approximately 2 weeks | No |
| Secondary | CICU Length of Stay | CICU length of stay will be calculated from the time the subject is admitted to the CICU post-op until they are discharged from the unit. This will be used as a secondary outcome. | approximately 1 week | No |
| Secondary | Mortality | Subject mortality will in the CICU will be used as a secondary outcome. | Duration of CICU stay, approximately 1 week | No |
| Secondary | ACTH Stimulation Test | AdrenoCorticoTropic Hormone stimulation test will be performed at least 24 hours pre-bypass and immediately after successful discontinuation of bypass and compared. These outcomes will be used as a secondary outcome. | 24 hours prebypass and 0 hours post-bypass | No |