Effect of Postop Steroids on Cardiovascular/Respiratory Function in Neonates Undergoing Cardiopulmonary Bypass

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jeffrey Alten, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01595386
First received: March 16, 2012
Last updated: October 12, 2015
Last verified: October 2015
Results First Received: January 28, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Heart Disease Congenital Complex
Interventions: Drug: Hydrocortisone
Drug: Normal Saline

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Normal Saline

The subjects will receive a bolus after successful completion of bypass and the post-pump adrenocorticotrophic hormone (ACTH) stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.

Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm.

Hydrocortisone

Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of cardiopulmonary bypass (CPB) and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.

Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off.


Participant Flow:   Overall Study
    Normal Saline     Hydrocortisone  
STARTED     21     19  
COMPLETED     21     19  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Normal Saline-Placebo

The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.

Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm.

Hydrocortisone

Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.

Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off.

Total Total of all reporting groups

Baseline Measures
    Normal Saline-Placebo     Hydrocortisone     Total  
Number of Participants  
[units: participants]
  21     19     40  
Age  
[units: Days]
Median (Inter-Quartile Range)
  6  
  (5 to 11)  
  5  
  (4 to 7)  
  6  
  (5 to 8)  
Gender  
[units: participants]
     
Female     8     5     13  
Male     13     14     27  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     5     3     8  
White     16     16     32  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     21     19     40  
Surgical Procedure  
[units: number of patients]
     
Norwood     7     6     13  
Arterial switch operation     6     6     12  
Interrupted aortic arch repair     3     4     7  
Aortic arch augmentation     1     1     2  
Truncus arteriosus repair     3     0     3  
other     1     2     3  



  Outcome Measures
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1.  Primary:   Incidence of Low Cardiac Output Syndrome (LCOS)   [ Time Frame: first 48 hours after cardiac intensive care unit (CICU) admission post-op ]

2.  Secondary:   Mean Number of Days Subjects Alive and Ventilator Free   [ Time Frame: up to 28 days post op ]

3.  Secondary:   Hospital Length of Stay   [ Time Frame: Admit to CICU till hospital discharge, approximately 3 weeks ]

4.  Secondary:   Changes in Baseline Inflammatory Mediators   [ Time Frame: 0, 4,12, 24, and 48 hours post bypass ]

5.  Secondary:   Average Inotrope Score   [ Time Frame: first 48 hours post-op ]

6.  Secondary:   Fluid Balance   [ Time Frame: 1st 48 hours post-op ]

7.  Secondary:   Changes in Baseline Arterial-venous Oxygen Saturation Difference   [ Time Frame: admit to the CICU ]

8.  Secondary:   Time Until First Extubation   [ Time Frame: Until discharge from hospital, approximately 2 weeks ]

9.  Secondary:   CICU Length of Stay   [ Time Frame: approximately 1 week ]

10.  Secondary:   Mortality   [ Time Frame: Duration of CICU stay, approximately 1 week ]

11.  Secondary:   ACTH Stimulation Test   [ Time Frame: 24 hours prebypass and 0 hours post-bypass ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
small, single-center trial; included subjects from more than one surgeon; all patients received preoperative and rescue steroids; definition of low cardiac output syndrome although appropriate must ultimately be arbitrary.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jeffrey Alten, M.D., Director of Clinical and Translational Research Department
Organization: University of Alabama at Birmingham, Pediatric Cardiac Critical Care
phone: 205-975-3123
e-mail: jalten@peds.uab.edu



Responsible Party: Jeffrey Alten, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01595386     History of Changes
Other Study ID Numbers: Postop Steroids after CPB
Study First Received: March 16, 2012
Results First Received: January 28, 2015
Last Updated: October 12, 2015
Health Authority: United States: Institutional Review Board