Impact of Pre-operative Steroids on Adrenal Insufficiency
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|ClinicalTrials.gov Identifier: NCT02956707|
Recruitment Status : Completed
First Posted : November 6, 2016
Last Update Posted : January 15, 2019
|Condition or disease||Intervention/treatment|
|Adrenal Insufficiency Neonatal||Other: No pre-operative steroids|
|Study Type :||Observational|
|Actual Enrollment :||50 participants|
|Official Title:||Impact of Pre-operative Steroids on Adrenal Insufficiency and Clinical Outcomes After Neonatal Cardiac Surgery With Cardiopulmonary Bypass|
|Actual Study Start Date :||July 2016|
|Actual Primary Completion Date :||January 12, 2019|
|Actual Study Completion Date :||January 12, 2019|
No pre-operative steroids
This is a prospectively enrolling group of 40 subjects.
Our current clinical practice has changed. We no longer administer pre-oeprative steroids to neonates undergoing surgery with cardiopulmonary bypass. These patients still receive their post-operative steroid infusion that starts after termination from bypass. This is their standard of care and does not change due to study enrollment.
Subject's enrolled in this trial have a ACTH stimulation test performed: pre-operative, immediately post-cardiopulmonary bypass prior to the initiation of their clinical steroids, and prior to leaving the cardiac intensive care unit.
Other: No pre-operative steroids
Due to new information provide from previous studies at our center the investigator instituted a clinical practice change remove steroid administration in the pre-operative period for all neonates undergoing surgery with cardiopulmonary bypass. This study is to evaluate this change.
This is a retrospective group of 40 subjects who were previously administered pre-operative steroids. These subjects also had ACTH testing performed pre-operative and immediately post-separation from cardiopulmonary bypass.
- Incidence of AI in neonates who do not receive preoperative methylprednisolone [ Time Frame: 1 year ]
- Hemodynamic parameters-Heart rate [ Time Frame: 1.5 hours post-CPB ]hemodynamic parameters collected every 15 minutes post-CPB for 1.5 hours or until the end of the procedure-heart rate
- Hemodynamic parameters- Blood pressure [ Time Frame: 1.5 hours post-CPB ]hemodynamic parameters collected every 15 minutes post-CPB for 1.5 hours or until the end of the procedure systolic blood pressure
- Hemodynamic parameters- Central venous pressure [ Time Frame: 1.5 hours post-CPB ]hemodynamic parameters collected every 15 minutes post-CPB for 1.5 hours or until the end of the procedure central venous pressure
- Hemodynamic parameters- Flank Near infrared spectroscopy [ Time Frame: 1.5 hours post-CPB ]hemodynamic parameters collected every 15 minutes post-CPB for 1.5 hours or until the end of the procedure flank near infrared spectroscopy.
- Hemodynamic parameters- cerebral near infrared spectroscopy [ Time Frame: 1.5 hours post-CPB ]hemodynamic parameters collected every 15 minutes post-CPB for 1.5 hours or until the end of the procedure cerebral near infrared spectroscopy.
- Laboratory values- lactacte [ Time Frame: 1 week post-CPB ]serum lactate
- Laboratory values- Hematocrit [ Time Frame: 1 week post-CPB ]hematocrit
- Laboratory values- hemoglobin [ Time Frame: 1 week post-CPB ]hemoglobin
- Laboratory values- Mixed venous [ Time Frame: 1 week post-CPB ]mixed venous oxygen saturation
- Laboratory values- carbon dioxide [ Time Frame: 1 week post-CPB ]veno-arterial carbon dioxide difference is the carbon dioxide from the venous blood gas minus the carbon dioxide from the arterial blood gas.
- Laboratory values- oxygen content [ Time Frame: 1 week post-CPB ]arterial and venous oxygen content is the saturation from the arterial blood gas and the saturation from the venous blood gas
- Colloid/blood product volumes administered in the cardiovascular operating room [ Time Frame: intraoperative period ]volume in mililiters of crystalloids and colloids (albumin, fresh frozen plasma, packed red blood cells, and platelets) administered in the operating room
- Inotrope infusion doses [ Time Frame: 48 hours post-CPB ]incidence of low cardiac output syndrome based on inotropic support requirement in the post-operative period
- Inflammatory cytokines [ Time Frame: 48 hours post-CPB ]plasma will be collected and sent for inflammatory cytokine analysis at the following time points: pre-operative, 0 hour, 4 hour, 24 hour, and 48 hour post-cardiopulmonary bypass
- ACTH stimulation test [ Time Frame: 14 days post-CPB ]
ACTH testing will be performed preoperative, immediately post-CPB, and prior to CICU discharge. This testing includes the following:
Baseline ACTH and cortisol levels, administration of cosyntropin, 30 minutes post-cosyntropin cortisol level
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956707
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35233|