- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00443599
SPECS: Safe Pediatric Euglycemia in Cardiac Surgery (SPECS)
Maintaining Normal Blood Sugar Levels in Children Undergoing Heart Surgery to Reduce the Risk of Infections and Improve Recovery (The SPECS Study)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Children undergoing heart surgery are under significant bodily stress, which can lead to higher than normal or lower than normal blood glucose levels. A synthetic form of insulin, a naturally occurring hormone in the body, can be injected into people to normalize blood glucose levels. Insulin is most commonly used to treat people with diabetes, but it is also used in hospitals to control blood glucose levels in patients. Previous studies of adult intensive care unit (ICU) patients have shown that patients whose blood sugar levels are maintained at normal levels with the use of insulin contract fewer infections and are released more quickly from the ICU than patients who do not maintain normal blood glucose levels. This study will use a continuous blood glucose monitoring system to detect changes in blood glucose levels. Intravenous insulin infusions will be used to then safely maintain normal blood glucose levels. The purpose of this study is to determine if maintaining normal blood glucose levels during an ICU stay will help decrease the incidence of infections and improve surgical recovery in young children following heart surgery.
This study will enroll children who are undergoing heart surgery that requires a cardiopulmonary bypass procedure. Participants will be randomly assigned to either a control group or the treatment group. All participants will receive usual care while in the ICU and will undergo continuous glucose monitoring. Participants in the treatment group will receive intravenous insulin infusions to keep their blood glucose within the normal range. While in the ICU, blood will be collected from all participants once a day for the first 3 days and then once a week to monitor glucose levels, hormone levels, and measurements of nutrition and immune function. On days 1 and 5 following surgery, participants who are on a ventilator will have their breath measured to monitor heart function and energy use. Thirty days and 1 year following surgery, study researchers will contact the participant's parent or doctor to collect information on health status and any new infections at the surgical site. Children who enroll in the study will be asked to participate in follow-up neurodevelopmental evaluations at 1 and 3 years of age to assess longer term cognitive effects of tight glycemic control in the ICU.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Children's Hospital Boston
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- C.S. Mott Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Undergoing heart surgery with cardiopulmonary bypass
- Recovering in the Cardiac ICU
Exclusion Criteria:
- Enrolled in another interventional clinical trial with related study outcomes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Insulin
Insulin was infused to target a blood glucose concentration of 80-110 mg/dL
|
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.
Other Names:
|
Active Comparator: Usual Care
Insulin was infused according to the discretion of the treating clinical team.
|
Participants receive standard Cardiac ICU care without tight blood glucose control.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Nosocomial Infections in the Cardiac ICU
Time Frame: Measured during participant's ICU stay, a median duration of 3 days.
|
Nosocomial infections that are attributable to the subject's stay in the Cardiac ICU, according to Center for Disease Control-defined criteria.
These definitions are extensive and cannot be accurately condensed to fit within this space.
Current CDC/NHSN criteria may be accessed through this URL: https://www.cdc.gov/nhsn/pdfs/pscmanual/17pscnosinfdef_current.pdf.
|
Measured during participant's ICU stay, a median duration of 3 days.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiac Index (CI)
Time Frame: Day 2 (day after cardiopulmonary bypass surgery).
|
Cardiac index is a measure of cardiac function, relating the cardiac output from the left ventricle in one minute to body surface area.
It is calculated using the Fick principle, using oxygen consumption measured with a metabolic cart, hemoglobin levels, and the difference between arterial and superior vena cava oxygen saturation measured by co-oximetry.
|
Day 2 (day after cardiopulmonary bypass surgery).
|
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.
|
Duration of ICU stay spans from post-operative cardiac ICU admission to cardiac ICU discharge.
|
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.
|
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.
|
Duration of hospital stay spans from post-operative cardiac ICU admission to hospital discharge.
|
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.
|
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.
|
Duration of endotracheal intubation spans from endotracheal tube intubation/initiation of mechanical ventilation to endotracheal tube extubation.
|
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.
|
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).
|
Mortality is assessed at hospital discharge and at 30 days.
|
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).
|
Mortality at 30 Days.
Time Frame: Measured at 30 days.
|
Mortality is assessed at hospital discharge and at 30 days.
If the participant is discharged from the hospital prior to 30 days, status is determined by a follow-up phone call to the family.
|
Measured at 30 days.
|
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.
|
Cardiac function is assessed by duration of vasoactive support.
|
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.
|
Immune Function
Time Frame: Post-operative day 7.
|
Immune function is assessed by C-reactive protein (CRP) on post-operative day 7.
|
Post-operative day 7.
|
Endocrine Function
Time Frame: Measured during participant's ICU stay on Day 7.
|
Endocrine function is assessed by total triiodothyronine (T3) on post-operative day 7.
|
Measured during participant's ICU stay on Day 7.
|
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.
|
Nutritional status assessed by percentage of total caloric intake as enteral nutrition during critical illness period.
|
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.
|
Neurodevelopmental Evaluation, Cognitive
Time Frame: Measured at one year of age.
|
Neurodevelopmental follow-up includes in-person testing using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), measured at one year of age.
|
Measured at one year of age.
|
Neurodevelopmental Evaluation, Language
Time Frame: Measured at one year of age.
|
Neurodevelopmental follow-up includes in-person testing using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), measured at one year of age.
|
Measured at one year of age.
|
Neurodevelopmental Evaluation, Motor
Time Frame: Measured at one year of age.
|
Neurodevelopmental follow-up includes in-person testing using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), measured at one year of age.
|
Measured at one year of age.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael Agus, MD, Boston Children's Hospital
Publications and helpful links
General Publications
- Agus MS, Steil GM, Wypij D, Costello JM, Laussen PC, Langer M, Alexander JL, Scoppettuolo LA, Pigula FA, Charpie JR, Ohye RG, Gaies MG; SPECS Study Investigators. Tight glycemic control versus standard care after pediatric cardiac surgery. N Engl J Med. 2012 Sep 27;367(13):1208-19. doi: 10.1056/NEJMoa1206044. Epub 2012 Sep 7.
- Agus MS, Javid PJ, Piper HG, Wypij D, Duggan CP, Ryan DP, Jaksic T. The effect of insulin infusion upon protein metabolism in neonates on extracorporeal life support. Ann Surg. 2006 Oct;244(4):536-44. doi: 10.1097/01.sla.0000237758.93186.c8.
- Piper HG, Alexander JL, Shukla A, Pigula F, Costello JM, Laussen PC, Jaksic T, Agus MS. Real-time continuous glucose monitoring in pediatric patients during and after cardiac surgery. Pediatrics. 2006 Sep;118(3):1176-84. doi: 10.1542/peds.2006-0347.
- Javid PJ, Halwick DR, Betit P, Thompson JE, Long K, Zhang Y, Jaksic T, Agus MS. The first use of live continuous glucose monitoring in patients on extracorporeal life support. Diabetes Technol Ther. 2005 Jun;7(3):431-9. doi: 10.1089/dia.2005.7.431.
- Agus MS, Javid PJ, Ryan DP, Jaksic T. Intravenous insulin decreases protein breakdown in infants on extracorporeal membrane oxygenation. J Pediatr Surg. 2004 Jun;39(6):839-44; discussion 839-44. doi: 10.1016/j.jpedsurg.2004.02.013.
- Gaies MG, Langer M, Alexander J, Steil GM, Ware J, Wypij D, Laussen PC, Newburger JW, Goldberg CS, Pigula FA, Shukla AC, Duggan CP, Agus MS; Safe Pediatric Euglycemia after Cardiac Surgery Study Group. Design and rationale of safe pediatric euglycemia after cardiac surgery: a randomized controlled trial of tight glycemic control after pediatric cardiac surgery. Pediatr Crit Care Med. 2013 Feb;14(2):148-56. doi: 10.1097/PCC.0b013e31825b549a.
- Sadhwani A, Asaro LA, Goldberg CS, Ware J, Butcher J, Gaies M, Smith C, Alexander JL, Wypij D, Agus MSD. Impact of tight glycemic control and hypoglycemia after pediatric cardiac surgery on neurodevelopmental outcomes at three years of age: Findings from a randomized clinical trial. BMC Pediatr. 2022 Sep 7;22(1):531. doi: 10.1186/s12887-022-03556-z.
- Sadhwani A, Asaro LA, Goldberg C, Ware J, Butcher J, Gaies M, Smith C, Alexander JL, Wypij D, Agus MS. Impact of Tight Glycemic Control on Neurodevelopmental Outcomes at 1 Year of Age for Children with Congenital Heart Disease: A Randomized Controlled Trial. J Pediatr. 2016 Jul;174:193-198.e2. doi: 10.1016/j.jpeds.2016.03.048. Epub 2016 Apr 23.
- Fisher JG, Sparks EA, Khan FA, Alexander JL, Asaro LA, Wypij D, Gaies M, Modi BP, Duggan C, Agus MS, Yu YM, Jaksic T. Tight Glycemic Control With Insulin Does Not Affect Skeletal Muscle Degradation During the Early Postoperative Period Following Pediatric Cardiac Surgery. Pediatr Crit Care Med. 2015 Jul;16(6):515-21. doi: 10.1097/PCC.0000000000000413.
- Agus MS, Asaro LA, Steil GM, Alexander JL, Silverman M, Wypij D, Gaies MG; SPECS Investigators. Tight glycemic control after pediatric cardiac surgery in high-risk patient populations: a secondary analysis of the safe pediatric euglycemia after cardiac surgery trial. Circulation. 2014 Jun 3;129(22):2297-304. doi: 10.1161/CIRCULATIONAHA.113.008124. Epub 2014 Mar 26.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 512
- 5R01HL088448-05 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hyperglycemia
-
Mayo ClinicCompletedHospital Hyperglycemia | Post-transplant HyperglycemiaUnited States
-
Zealand University HospitalNot yet recruitingStress Hyperglycemia | Postoperative Hyperglycemia
-
University of CopenhagenUnknownSurgery--Complications | Hyperglycemia Stress | Hyperglycemia Steroid-inducedDenmark
-
University of LeedsCompletedEffect of Food on Postprandial HyperglycemiaUnited Kingdom
-
Emory UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National...RecruitingHyperglycemia StressUnited States
-
Loughborough UniversityUniversity of BedfordshireCompletedPostprandial HyperglycemiaUnited Kingdom
-
Centre Hospitalier Universitaire de BesanconEli Lilly and Company; AstraZenecaCompleted
-
Medical University of ViennaCompleted
-
Addis Ababa UniversityCompletedHyperglycemia, Postprandial
-
University of Eastern FinlandFinnsugar LtdCompletedHyperglycemia, PostprandialFinland
Clinical Trials on Insulin
-
Munich Municipal HospitalNovo Nordisk A/SUnknownType 2 Diabetes MellitusGermany
-
Novo Nordisk A/SCompletedDiabetes | Diabetes Mellitus, Type 1Germany
-
Novo Nordisk A/SCompletedDiabetes | Diabetes Mellitus, Type 1United States, Poland, Puerto Rico, Russian Federation, United Kingdom, Denmark, France, Israel, Australia, Romania
-
Novo Nordisk A/SCompletedDiabetes | Diabetes Mellitus, Type 1United States, India, Russian Federation, Belgium, Spain, Israel, Croatia, Serbia, North Macedonia, South Africa, Slovenia, Brazil, Poland, Canada, Czechia
-
Novo Nordisk A/SCompletedDiabetes | Diabetes Mellitus, Type 1Croatia, Italy, Slovakia, Denmark, Macedonia, The Former Yugoslav Republic of, Norway, Russian Federation, Finland, France, Poland, Greece, Romania, Sweden, Czech Republic, Argentina
-
Novo Nordisk A/SCompletedDiabetes Mellitus, Type 2 | DiabetesUnited States, France, Austria, Norway, Algeria
-
Novo Nordisk A/SCompletedDiabetes Mellitus, Type 2 | Diabetes | Diabetes Mellitus, Type 1Germany
-
Novo Nordisk A/STerminatedDiabetes | Diabetes Mellitus, Type 1United Kingdom
-
Novo Nordisk A/SCompletedDiabetes | Diabetes Mellitus, Type 1Germany
-
Novo Nordisk A/SCompletedDiabetes | Diabetes Mellitus, Type 1Austria