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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00590018
First Posted: January 10, 2008
Last Update Posted: May 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Heather Dickerson, Baylor College of Medicine
Results First Submitted: February 23, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Triple (Participant, Care Provider, 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 
Overall Participants Analyzed 
[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
First Submitted: December 28, 2007
First Posted: January 10, 2008
Results First Submitted: February 23, 2016
Results First Posted: May 26, 2016
Last Update Posted: May 26, 2016