Tight glycemic control targeting blood glucose levels of 80 to 100 mg/dL, as opposed to a higher level within the usual care range, did not benefit critically ill infants and children with hyperglycemia, study results published in the New England Journal of Medicine indicate.1
“These results complement recent findings from two important studies in related pediatric critical care populations,” senior study investigator Vinay M. Nadkarni, MD, a critical care specialist at the Children’s Hospital of Philadelphia said in a news release.2 “It’s clear that high blood sugars are associated with worse outcomes in children, but controlling blood sugar to lower targets within the usual care range does not appear to provide additional benefit.”
In the HALF-PINT study (Heart And Lung Failure – Pediatric Insulin Titration Trial; ClinicalTrials.gov identifier: NCT01565941), Dr Nadkarni and colleagues randomly assigned 713 critically ill children, excluding patients who had undergone cardiac surgery, aged 2 weeks to 17 years from 35 pediatric centers to a lower-target range of glycemic control (80 to 110 mg/dL; n = 360) or a higher-target range (150 to 180 mg/dL; n = 353).1 The primary outcome was the number of intensive care unit (ICU)-free days up to day 28 (mortality-adjusted length of ICU stay). Continuous glucose monitoring (CGM) and explicit methods for insulin adjustment guided clinicians’ decision-making.
The data and safety monitoring board recommended HALF-PINT be stopped early due to the lack of benefit and potential for harm.
Results from the intention-to-treat analysis indicated no significant difference in median number of ICU-free days between the lower-target and higher-target groups (19.4 vs 19.4 days, respectively; P =.58). Additionally, in per-protocol analyses, patients in the lower-target group had a lower median time-weighted average glucose level when compared with the higher-target group (109 mg/dL vs 123 mg/dL; P <.001). The researchers also noted that mortality, severity of organ dysfunction, and number of ventilator-free days did not differ between groups.
However, the rates of healthcare-associated infections (3.4% vs 1.1%; P =.04) and severe hypoglycemia (5.2% vs 2.0%; P =.03) were significantly higher in the higher-target group compared with the lower-target group.
“As the latest large pediatric trial to find no significant difference, the HALF-PINT study represents a third strike against glucose control to a target of 80 to 110 mg/dL,” Dr Nadkarni said in the release.2
- There may have been a lag between onset of hyperglycemia and treatment because the researchers did not obtain informed consent until after hyperglycemia was confirmed.
- Because it was impossible for the bedside team to not be unaware of study-group assignment, HALF-PINT precluded blinding.
- There was no third study group in which hyperglycemia was not treated.
- Agus MSD, Wypij D, Hirshberg EL, et al; for the HALF-PINT Study Investigators and the PALISI Network. Tight glycemic control in critically ill children [published online January 24, 2017]. N Engl J Med. doi: 10.1056/NEJMoa1612348
- Critically ill children don’t benefit from tightest control of blood sugar [news release]. Philadelphia, PA: Children’s Hospital of Philadelphia; January 24, 2017. Available at: www.newswise.com/articles/view/668118. Accessed January 30, 2017.