Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Heart And Lung Failure - Pediatric INsulin Titration Trial (HALF-PINT)
Brief Summary: Stress hyperglycemia, a state of abnormal metabolism with supra-normal blood glucose levels, is often seen in critically ill patients. Tight glycemic control (TGC) was originally shown to reduce morbidity and mortality in a landmark randomized clinical trial (RCT) of adult critically ill surgical patients but has since come under intense scrutiny due to conflicting results in recent adult trials. One pediatric RCT has been published to date that demonstrated survival benefit but was complicated by an unacceptably high rate of severe hypoglycemia. The Heart And Lung Failure - Pediatric INsulin Titration (HALF-PINT) trial is a multi-center, randomized clinical treatment trial comparing two ranges of glucose control in hyperglycemic critically ill children with heart and/or lung failure. Both target ranges of glucose control fall within the range of "usual care" for critically ill children managed in pediatric intensive care units.

The purpose of the study is to determine the comparative effectiveness of tight glycemic control to a target range of 80-110 mg/dL (TGC-1, 4.4-6.1 mmol/L) vs. a target range of 150-180 mg/dL (TGC-2, 8.3-10.0 mmol/L) on hospital mortality and intensive care unit (ICU) length of stay (LOS) in hyperglycemic critically ill children with cardiovascular and/or respiratory failure. This will be accomplished using an explicit insulin titration algorithm and continuous glucose monitoring to safely achieve these glucose targets. Both groups will receive identical standardized intravenous glucose at an age-appropriate rate in order to provide basal calories and mitigate hypoglycemia. Insulin infusions will be titrated with an explicit algorithm combined with continuous glucose monitoring using a protocol that has been safely implemented in 490 critically ill infants and children.


Options:
A: Arm Label: A; Type: ACTIVE_COMPARATOR; Interventions: Drug: conventional insulin therapy (Actrapid IV only for excessive hyperglycemia) | Arm Label: B; Type: EXPERIMENTAL; Interventions: Drug: intensive insulin therapy (Actrapid IV to normoglycemia) | Intervention Type: DRUG; Name: intensive insulin therapy (Actrapid IV to normoglycemia); Assigned to Arm(s): B | Intervention Type: DRUG; Name: conventional insulin therapy (Actrapid IV only for excessive hyperglycemia); Assigned to Arm(s): A
B: Arm Label: Early parenteral nutrition; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Late parenteral nutrition; Type: EXPERIMENTAL; Interventions: Other: Late parenteral nutrition | Intervention Type: OTHER; Name: Late parenteral nutrition; Assigned to Arm(s): Late parenteral nutrition
C: Arm Label: Tight Glycemic Control 1 (TGC-1); Type: ACTIVE_COMPARATOR; Interventions: Drug: Insulin | Arm Label: Tight Glycemic Control 2 (TGC-2); Type: ACTIVE_COMPARATOR; Interventions: Drug: Insulin | Intervention Type: DRUG; Name: Insulin; Assigned to Arm(s): Tight Glycemic Control 1 (TGC-1) | Intervention Type: DRUG; Name: Insulin; Assigned to Arm(s): Tight Glycemic Control 2 (TGC-2)
D: Arm Label: EN only; Type: EXPERIMENTAL; Interventions: Other: Withholding PN during the first week of ICU stay | Arm Label: EN plus early PN; Type: ACTIVE_COMPARATOR; Interventions: Drug: Oliclinomel N71000 OR N71000E // Clinimix N17G35 OR N17G35E | Intervention Type: OTHER; Name: Withholding PN during the first week of ICU stay; Assigned to Arm(s): EN only | Intervention Type: DRUG; Name: Oliclinomel N71000 OR N71000E // Clinimix N17G35 OR N17G35E; Assigned to Arm(s): EN plus early PN

Answer: C