Hyperglycemia Clinical Trial
— SPECSOfficial title:
Maintaining Normal Blood Sugar Levels in Children Undergoing Heart Surgery to Reduce the Risk of Infections and Improve Recovery (The SPECS Study)
Verified date | July 2022 |
Source | Boston Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Critically ill children, including children undergoing heart surgery, commonly develop elevated blood glucose (also known as "blood sugar") levels during their illness, which can lead to poor health outcomes and an increased risk of death. This study will examine the effectiveness of maintaining normal blood glucose levels at decreasing infections and improving recovery in young children undergoing heart surgery.
Status | Completed |
Enrollment | 989 |
Est. completion date | January 2014 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 36 Months |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | C.S. Mott Children's Hospital | Ann Arbor | Michigan |
United States | Children's Hospital Boston | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Children's Hospital | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
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. — View Citation
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. — View Citation
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. 2 — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Nosocomial Infections in the Cardiac ICU | 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 | Cardiac Index (CI) | 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). | |
Secondary | Duration of ICU Stay | 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. | |
Secondary | Duration of Hospital Stay | 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. | |
Secondary | Duration of Endotracheal Intubation | 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. | |
Secondary | Mortality at Hospital Discharge. | 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). | |
Secondary | Mortality 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. | |
Secondary | Cardiac Function | 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. | |
Secondary | Immune Function | Immune function is assessed by C-reactive protein (CRP) on post-operative day 7. | Post-operative day 7. | |
Secondary | Endocrine Function | Endocrine function is assessed by total triiodothyronine (T3) on post-operative day 7. | Measured during participant's ICU stay on Day 7. | |
Secondary | Nutritional Status | 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. | |
Secondary | Neurodevelopmental Evaluation, Cognitive | 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.
Bayley-III cognitive composite score ranges from 55-145, Bayley-III language composite score ranges from 47-153, and Bayley-III motor composite score ranges from 46-154. Higher values indicate better neurodevelopmental outcomes. These three composite scores cannot be combined and are presented as separate scores in the literature. |
Measured at one year of age. | |
Secondary | Neurodevelopmental Evaluation, Language | 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.
Bayley-III cognitive composite score ranges from 55-145, Bayley-III language composite score ranges from 47-153, and Bayley-III motor composite score ranges from 46-154. Higher values indicate better neurodevelopmental outcomes. These three composite scores cannot be combined and are presented as separate scores in the literature. |
Measured at one year of age. | |
Secondary | Neurodevelopmental Evaluation, Motor | 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.
Bayley-III cognitive composite score ranges from 55-145, Bayley-III language composite score ranges from 47-153, and Bayley-III motor composite score ranges from 46-154. Higher values indicate better neurodevelopmental outcomes. These three composite scores cannot be combined and are presented as separate scores in the literature. |
Measured at one year of age. |
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