Corticosteroids in Postoperative Critically Ill Neonates With Low Cardiac Output Syndrome With Congenital Heart Disease (Corti)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Heather Dickerson, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00590018
First received: December 28, 2007
Last updated: April 20, 2016
Last verified: April 2016
Results First Received: February 23, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Cardiac Output, Low
Interventions: Drug: Hydrocortisone
Drug: Placebo

  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
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Reporting Groups
  Description
Hydrocortisone Subjects in this arm will receive a 5 day tapering course of hydrocortisone. Hydrocortisone: Hydrocortisone taper (100mg/m2/day --> 25mg/m2/day) over 5 days intravenously.
Placebo Subjects in this arm will receive 5 days of placebo. Placebo: Placebo for 5 days intravenously.

Participant Flow:   Overall Study
    Hydrocortisone     Placebo  
STARTED     9     9  
COMPLETED     9     9  
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.
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Reporting Groups
  Description
Hydrocortisone Subjects in this arm will receive a 5 day tapering course of hydrocortisone. Hydrocortisone: Hydrocortisone taper (100mg/m2/day --> 25mg/m2/day) over 5 days intravenously.
Placebo Subjects in this arm will receive 5 days of placebo. Placebo: Placebo for 5 days intravenously.
Total Total of all reporting groups

Baseline Measures
    Hydrocortisone     Placebo     Total  
Number of Participants  
[units: participants]
  9     9     18  
Age  
[units: participants]
     
<=18 years     9     9     18  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: days]
Mean (Standard Deviation)
  10  (10.58)     7  (4.12)     8.5  (7.94)  
Gender  
[units: participants]
     
Female     5     4     9  
Male     4     5     9  
Region of Enrollment  
[units: participants]
     
United States     9     9     18  
Inotrope score [1]
[units: units on a scale]
Mean (Standard Deviation)
  23.46  (3.79)     22.11  (2.31)     22.78  (3.12)  
[1] Inotrope score: epinephrine (mcg/kg/min x 100) + norepinephrine (mcg/kg/min x 100) + phenylephrine (mcg/kg/min x 100) + dopamine (mcg/kg/min x1) + dobutamine (mcg/kg/min x 1) + milrinone (mcg/kg/min x15). The higher the score the higher the inotrope requirements and generally the sicker the patient. Minimum would be 0. Maximum would be 85.



  Outcome Measures
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1.  Primary:   Blood Pressure.   [ Time Frame: 2 days ]

2.  Secondary:   Change in Inotrope Score. This is the Change in the Inotrope Score Between 15 Minutes Prior to Drug Administration and at 2 Days After Drug Administration.   [ Time Frame: 2 days ]


  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
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  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: Dr. Heather Dickerson
Organization: Baylor College of Medicine
phone: 832-826-5637
e-mail: had@bcm.edu


Publications:

Responsible Party: Heather Dickerson, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00590018     History of Changes
Other Study ID Numbers: H-12030
Study First Received: December 28, 2007
Results First Received: February 23, 2016
Last Updated: April 20, 2016
Health Authority: United States: Institutional Review Board