Intensive Care Medicine

, 35:1738

A prospective randomised multi-centre controlled trial on tight glucose control by intensive insulin therapy in adult intensive care units: the Glucontrol study

  • Jean-Charles Preiser
  • Philippe Devos
  • Sergio Ruiz-Santana
  • Christian Mélot
  • Djillali Annane
  • Johan Groeneveld
  • Gaetano Iapichino
  • Xavier Leverve
  • Gérard Nitenberg
  • Pierre Singer
  • Jan Wernerman
  • Michael Joannidis
  • Adela Stecher
  • René Chioléro
Original

DOI: 10.1007/s00134-009-1585-2

Cite this article as:
Preiser, JC., Devos, P., Ruiz-Santana, S. et al. Intensive Care Med (2009) 35: 1738. doi:10.1007/s00134-009-1585-2

Abstract

Purpose

An optimal target for glucose control in ICU patients remains unclear. This prospective randomized controlled trial compared the effects on ICU mortality of intensive insulin therapy (IIT) with an intermediate glucose control.

Methods

Adult patients admitted to the 21 participating medico-surgical ICUs were randomized to group 1 (target BG 7.8–10.0 mmol/L) or to group 2 (target BG 4.4–6.1 mmol/L).

Results

While the required sample size was 1,750 per group, the trial was stopped early due to a high rate of unintended protocol violations. From 1,101 admissions, the outcomes of 542 patients assigned to group 1 and 536 of group 2 were analysed. The groups were well balanced. BG levels averaged in group 1 8.0 mmol/L (IQR 7.1–9.0) (median of all values) and 7.7 mmol/L (IQR 6.7–8.8) (median of morning BG) versus 6.5 mmol/L (IQR 6.0–7.2) and 6.1 mmol/L (IQR 5.5–6.8) for group 2 (p < 0.0001 for both comparisons). The percentage of patients treated with insulin averaged 66.2 and 96.3%, respectively. Proportion of time spent in target BG was similar, averaging 39.5% and 45.1% (median (IQR) 34.3 (18.5–50.0) and 39.3 (26.2–53.6)%) in the groups 1 and 2, respectively. The rate of hypoglycaemia was higher in the group 2 (8.7%) than in group 1 (2.7%, p < 0.0001). ICU mortality was similar in the two groups (15.3 vs. 17.2%).

Conclusions

In this prematurely stopped and therefore underpowered study, there was a lack of clinical benefit of intensive insulin therapy (target 4.4–6.1 mmol/L), associated with an increased incidence of hypoglycaemia, as compared to a 7.8–10.0 mmol/L target. (ClinicalTrials.gov # NCT00107601, EUDRA-CT Number: 200400391440).

Keywords

Insulin therapy Insulin resistance Stress hyperglycaemia Hypoglycaemia Critical illness 

Supplementary material

134_2009_1585_MOESM1_ESM.doc (56 kb)
Supplementary material 1 (DOC 56 kb)

Copyright information

© Springer-Verlag 2009

Authors and Affiliations

  • Jean-Charles Preiser
    • 1
    • 14
  • Philippe Devos
    • 1
  • Sergio Ruiz-Santana
    • 2
  • Christian Mélot
    • 3
  • Djillali Annane
    • 4
  • Johan Groeneveld
    • 5
  • Gaetano Iapichino
    • 6
  • Xavier Leverve
    • 7
  • Gérard Nitenberg
    • 8
  • Pierre Singer
    • 9
  • Jan Wernerman
    • 10
  • Michael Joannidis
    • 11
  • Adela Stecher
    • 12
  • René Chioléro
    • 13
  1. 1.Department of General Intensive CareUniversity HospitalLiegeBelgium
  2. 2.Department of Intensive CareDr Negrin University Hospital, University of Las Palmas de Gran CanariaLas PalmasSpain
  3. 3.Department of Intensive CareErasme HospitalBrusselsBelgium
  4. 4.Department of Intensive CareRaymond Poincaré HospitalGarchesFrance
  5. 5.Department of Intensive CareFree University Medical CentreAmsterdamThe Netherlands
  6. 6.Department of Anaesthesia and Intensive CareHospital of San Paolo, University of MilanoMilanItaly
  7. 7.Department of Emergency and Intensive CareJoseph Fourier UniversityGrenobleFrance
  8. 8.Department of Intensive CareGustave-Roussy InstituteVillejuifFrance
  9. 9.Department of Intensive CareRabin Medical CentrePetah TiqvaIsrael
  10. 10.Department of Anaesthesia and Intensive CareKarolinska InstituteStockholmSweden
  11. 11.Department of Intensive CareUniversity Clinic InnsbruckInnsbruckAustria
  12. 12.Department of Anaesthesia and Intensive CareUniversity Medical CentreLjubljanaSlovenia
  13. 13.Department of Intensive CareUniversity Hospital LausanneLausanneSwitzerland
  14. 14.Department of General Intensive CareUniversity Hospital of Liege, University of Liege, Domaine Universitaire du Sart-TilmanLiegeBelgium