SPECS: Safe Pediatric Euglycemia in Cardiac Surgery

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Michael Agus, Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00443599
First received: March 5, 2007
Last updated: March 13, 2014
Last verified: March 2014
Results First Received: January 28, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Heart Defects, Congenital
Hyperglycemia
Interventions: Drug: Insulin
Other: Usual Care

  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
Enrollment began in September 2006 and ended in May 2012. All subjects received the study intervention in the Cardiac ICUs at Boston Children's Hospital (Boston, MA) and C.S. Mott Children's Hospital (Ann Arbor, MI).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants gave consent prior to cardiopulmonary bypass (CPB) surgery, randomization occurred perioperatively and initiation of the protocol occurred postoperatively. 9 subjects were removed from the study between the time of randomization and initiation of the protocol (4 for cancellation of CPB , 3 for physician decision, 2 for death).

Reporting Groups
  Description
Tight Glycemic Control Insulin : Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter.
Standard Care Usual Care : Participants receive standard Cardiac ICU care without tight blood glucose control.

Participant Flow:   Overall Study
    Tight Glycemic Control     Standard Care  
STARTED     496 [1]   493 [2]
COMPLETED     490 [3]   490 [3]
NOT COMPLETED     6     3  
Physician Decision                 2                 1  
Death                 1                 1  
Cardiopulmonary bypass canceled                 3                 1  
[1] Randomly Assigned to Tight Glycemic Control
[2] Randomly Assigned to Standard Care
[3] Included in per-protocol analysis



  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
Tight Glycemic Control Insulin : Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter.
Standard Care Usual Care : Participants receive standard Cardiac ICU care without tight blood glucose control.
Total Total of all reporting groups

Baseline Measures
    Tight Glycemic Control     Standard Care     Total  
Number of Participants  
[units: participants]
  490     490     980  
Age  
[units: participants]
     
<=18 years     490     490     980  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: months]
Median ( Inter-Quartile Range )
  4.3  
  ( 1.8 to 9.7 )  
  4.9  
  ( 2.3 to 10.8 )  
  4.6  
  ( 2 to 10.2 )  
Gender  
[units: participants]
     
Female     241     217     458  
Male     249     273     522  
Region of Enrollment  
[units: participants]
     
United States     490     490     980  



  Outcome Measures

1.  Primary:   Incidence of Nosocomial Infections in the Cardiac ICU   [ Time Frame: Measured during participant's ICU stay ]

2.  Primary:   Cardiac Index (CI)   [ Time Frame: Measured 24 hours after cardiopulmonary bypass surgery ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Duration of ICU Stay   [ Time Frame: Measured at the end of participant's ICU stay ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Duration of Hospital Stay   [ Time Frame: Measured at the end of participant's hospital stay ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Duration of Endotracheal Intubation   [ Time Frame: Measured during participant's ICU stay ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Mortality   [ Time Frame: Measured during participant's hospital stay and at 30-day and 1-year follow-ups ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Cardiac Function   [ Time Frame: Measured during participant's ICU stay ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Immune Function   [ Time Frame: Measured during participant's ICU stay ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Endocrine Function   [ Time Frame: Measured during participant's ICU stay ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   Nutritional Status   [ Time Frame: Measured during participant's ICU stay ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

11.  Secondary:   Neurodevelopmental Evaluation   [ Time Frame: 1 and 3 years of age ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Michael Agus
Organization: Boston Children's Hospital
phone: 617-355-5849
e-mail: michael.agus@childrens.harvard.edu


Publications of Results:
Other Publications:
Publications automatically indexed to this study:

Responsible Party: Michael Agus, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00443599     History of Changes
Other Study ID Numbers: 512, 5R01HL088448-05
Study First Received: March 5, 2007
Results First Received: January 28, 2014
Last Updated: March 13, 2014
Health Authority: United States: Federal Government