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SPECS: Safe Pediatric Euglycemia in Cardiac Surgery (SPECS)

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Michael Agus, Boston Children's Hospital
ClinicalTrials.gov Identifier:
NCT00443599
First received: March 5, 2007
Last updated: March 21, 2017
Last verified: March 2017
Results First Received: January 28, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   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 
Overall Participants Analyzed 
[Units: Participants]
 490   490   980 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      490 100.0%      490 100.0%      980 100.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0% 
>=65 years      0   0.0%      0   0.0%      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) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      241  49.2%      217  44.3%      458  46.7% 
Male      249  50.8%      273  55.7%      522  53.3% 
Region of Enrollment 
[Units: Participants]
     
United States   490   490   980 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Incidence of Nosocomial Infections in the Cardiac ICU   [ Time Frame: Measured during participant's ICU stay, a median duration of 3 days. ]

2.  Secondary:   Cardiac Index (CI)   [ Time Frame: Day 2 (day after cardiopulmonary bypass surgery). ]

3.  Secondary:   Duration of ICU Stay   [ Time Frame: The duration of cardiac ICU stay was evaluated from the date of postoperative cardiac ICU admission until the date of cardiac ICU discharge or date of death from any cause, whichever came first, assessed up to 30 days. ]

4.  Secondary:   Duration of Hospital Stay   [ Time Frame: The duration of hospital stay was evaluated from the day of postoperative cardiac ICU admission until the day of hospital discharge or day of death from any cause, whichever came first, assessed up to 30 days. ]

5.  Secondary:   Duration of Endotracheal Intubation   [ Time Frame: The duration of endotracheal intubation (mechanical ventilation) was evaluated from the day of postoperative cardiac ICU admission until the day of extubation or day of death from any cause, whichever came first, assessed up to 30 days. ]

6.  Secondary:   Mortality at Hospital Discharge.   [ Time Frame: Mortality at hospital discharge (In-hospital mortality) was evaluated on the day of hospital discharge or day of death from any cause, whichever came first (no upper limit). ]

7.  Secondary:   Mortality at 30 Days.   [ Time Frame: Measured at 30 days. ]

8.  Secondary:   Cardiac Function   [ Time Frame: The duration of vasoactive support was evaluated from the day of postoperative cardiac ICU admission until the last day of vasoactive support or day of death from any cause, whichever came first, assessed up to 30 days. ]

9.  Secondary:   Immune Function   [ Time Frame: Post-operative day 7. ]

10.  Secondary:   Endocrine Function   [ Time Frame: Measured during participant’s ICU stay on Day 7. ]

11.  Secondary:   Nutritional Status   [ Time Frame: The percentage of total caloric intake was evaluated from the day of postoperative cardiac ICU admission until the last day of the critical illness period, as defined by the presence of the arterial catheter, assessed up to 30 days. ]

12.  Secondary:   Neurodevelopmental Evaluation, Cognitive   [ Time Frame: Measured at one year of age. ]

13.  Secondary:   Neurodevelopmental Evaluation, Language   [ Time Frame: Measured at one year of age. ]

14.  Secondary:   Neurodevelopmental Evaluation, Motor   [ Time Frame: Measured at one year of age. ]


  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:  
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 by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Michael Agus, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT00443599     History of Changes
Other Study ID Numbers: 512
5R01HL088448-05 ( US NIH Grant/Contract Award Number )
Study First Received: March 5, 2007
Results First Received: January 28, 2014
Last Updated: March 21, 2017