Evidence map›Paper›PMID 22957521›Full record

Trial reportThe New England journal of medicine2012

Tight glycemic control versus standard care after pediatric cardiac surgery.

Michael S D Agus, Garry M Steil, David Wypij, John M Costello, Peter C Laussen, Monica Langer, Jamin L Alexander, Lisa A Scoppettuolo, Frank A Pigula, John R Charpie and 3 more

5 registry-linked trialsOpen access · bronzeAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The New England journal of medicine, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 95 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
95citing papers in PubMed, 7 pooled it
20.2field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00443599 nacompletednot on this map

Maintaining Normal Blood Sugar Levels in Children Undergoing Heart Surgery to Reduce the Risk of Infections and Improve Recovery (The SPECS Study)

TypeinterventionalSponsorBoston Children's HospitalRan2006 to 2014Enrolled989ConditionsHeart Defects, Congenital, HyperglycemiaArmsInsulin, Usual Care
NCT02299479 nacompletednot on this mapstarted 2015, after this paper: background citation

Adjusting Insulin Delivery to Activity (AIDA)

TypeinterventionalSponsorBoston Children's HospitalRan2015 to 2017Enrolled20ConditionsDiabetes, Nocturnal HypoglycemiaArmsDexcom G4 Platinum CGM, Activity monitor
NCT02300285 naterminatednot on this mapstarted 2015, after this paper: background citation

Efficacy of Continuous Glucose Monitoring in Neonates With Hypoglycemia

TypeinterventionalSponsorBoston Children's HospitalRan2015 to 2018Enrolled6ConditionsHypoglycemia, Newborn MorbidityArmsContinuous Glucose Monitoring
NCT02583776 phase4completednot on this mapstarted 2015, after this paper: background citation

NEONATAL HYPOGLYCEMIA and CONTINUOUS GLUCOSE MONITORING: A RANDOMIZED CONTROLLED TRIAL IN PRETERM INFANTS

TypeinterventionalSponsorUniversity Hospital PadovaRan2015 to 2016Enrolled50ConditionsInfant, Very Low Birth Weight, Neonatal HypoglycemiaArmsUnblinded - CGM, Blinded - CGM
NCT04347590 naunknown statusnot on this mapstarted 2020, after this paper: background citation

Impact of Continuous Glucose Monitoring on Cerebral Oxygenation in Preterm Infants (the Babyglucolight Trial)

TypeinterventionalSponsorUniversity Hospital PadovaRan2020 to 2025Enrolled60ConditionsInfant Development, Hypoglycemia Neonatal, Neurodevelopmental AbnormalityArmsUnblinded - CGM (Medtronic Guardian), Blinded - CGM (Medtronic Guardian)
3 · Its place in the literature

Who cites it

95 citing papers in PubMed, 7 syntheses or guidelines pooled it, 281 citations in OpenAlex.

  1. Pooled it
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  13. Tight Glycemic Control in Critically Ill Children.The New England journal of medicine · 2017
    Trial
  14. Trial
  15. Trial
  16. Trial
  17. Intensive Versus Conventional Glycemic Control in Patients with Diabetes During Enteral Nutrition After Gastrectomy.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2015
    Trial
  18. Tight Glycemic Control With Insulin Does Not Affect Skeletal Muscle Degradation During the Early Postoperative Period Following Pediatric Cardiac Surgery.Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies · 2015
    Trial
  19. Trial
  20. Impact of stress-induced diabetes on outcomes in severely burned children.Journal of the American College of Surgeons · 2014
    Trial

35 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 5 institutions in 1 country.

Michael S D AgusBoston Children's Hospital and Harvard Medical School, Boston, MA 02115, USA. michael.agus@childrens.harvard.edu.
Garry M Steil
David Wypij
John M Costello
Peter C Laussen
Monica Langer
Jamin L Alexander
Lisa A Scoppettuolo
Frank A Pigula
John R Charpie
Richard G Ohye
Michael G Gaies
SPECS Study Investigators
Boston Children's Hospital · USHarvard University · USUniversity of Michigan–Ann Arbor · USC. S. Mott Children's Hospital · USMaine Medical Center · US

Funding

SPECS: Safe Pediatric Euglycemia in Cardiac SurgeryR01HL088448 · NHLBI · BOSTON CHILDREN'S HOSPITAL · PI AGUS, MICHAEL SD · 2007 to 2011
$4.0M
NCRR NIH HHS UL1 RR 05758NHLBI NIH HHS R01 HL088448NHLBI NIH HHS R01HL088448NHLBI NIH HHS R01HL088448-02S1
6 · The paper itself

Abstract

backgroundIn some studies, tight glycemic control with insulin improved outcomes in adults undergoing cardiac surgery, but these benefits are unproven in critically ill children at risk for hyperinsulinemic hypoglycemia. We tested the hypothesis that tight glycemic control reduces morbidity after pediatric cardiac surgery.

methodsIn this two-center, prospective, randomized trial, we enrolled 980 children, 0 to 36 months of age, undergoing surgery with cardiopulmonary bypass. Patients were randomly assigned to either tight glycemic control (with the use of an insulin-dosing algorithm targeting a blood glucose level of 80 to 110 mg per deciliter [4.4 to 6.1 mmol per liter]) or standard care in the cardiac intensive care unit (ICU). Continuous glucose monitoring was used to guide the frequency of blood glucose measurement and to detect impending hypoglycemia. The primary outcome was the rate of health care-associated infections in the cardiac ICU. Secondary outcomes included mortality, length of stay, organ failure, and hypoglycemia.

resultsA total of 444 of the 490 children assigned to tight glycemic control (91%) received insulin versus 9 of 490 children assigned to standard care (2%). Although normoglycemia was achieved earlier with tight glycemic control than with standard care (6 hours vs. 16 hours, P<0.001) and was maintained for a greater proportion of the critical illness period (50% vs. 33%, P<0.001), tight glycemic control was not associated with a significantly decreased rate of health care-associated infections (8.6 vs. 9.9 per 1000 patient-days, P=0.67). Secondary outcomes did not differ significantly between groups, and tight glycemic control did not benefit high-risk subgroups. Only 3% of the patients assigned to tight glycemic control had severe hypoglycemia (blood glucose <40 mg per deciliter [2.2 mmol per liter]).

conclusionsTight glycemic control can be achieved with a low hypoglycemia rate after cardiac surgery in children, but it does not significantly change the infection rate, mortality, length of stay, or measures of organ failure, as compared with standard care. (Funded by the National Heart, Lung, and Blood Institute and others; SPECS ClinicalTrials.gov number, NCT00443599.).

Indexed as

Cardiac Surgical ProceduresBlood GlucoseChild, PreschoolCritical IllnessFemaleHumansHyperglycemiaHypoglycemiaHypoglycemic AgentsInfantInfectionsIntensive Care Units, PediatricIntention to Treat AnalysisMalePostoperative ComplicationsBlood GlucoseHypoglycemic Agents

Identifiers

PMID22957521
PMCPMC3501680
OpenAlexW2027766207

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.