Strict glycaemic control in patients hospitalised in a mixed medical and surgical intensive care unit: a randomised clinical trial.
BACKGROUND
Critically ill patients can develop hyperglycaemia even if they do not have diabetes. Intensive insulin therapy decreases morbidity and mortality rates in patients in a surgical intensive care unit (ICU) and decreases morbidity in patients in a medical ICU. The effect of this therapy on patients in a mixed medical/surgical ICU is unknown. Our goal was to assess whether the effect of intensive insulin therapy, compared with standard therapy, decreases morbidity and mortality in patients hospitalised in a mixed ICU.


METHODS
This is a prospective, randomised, non-blinded, single-centre clinical trial in a medical/surgical ICU. Patients were randomly assigned to receive either intensive insulin therapy to maintain glucose levels between 80 and 110 mg/dl (4.4 to 6.1 mmol/l) or standard insulin therapy to maintain glucose levels between 180 and 200 mg/dl (10 and 11.1 mmol/l). The primary end point was mortality at 28 days.


RESULTS
Over a period of 30 months, 504 patients were enrolled. The 28-day mortality rate was 32.4% (81 of 250) in the standard insulin therapy group and 36.6% (93 of 254) in the intensive insulin therapy group (Relative Risk [RR]: 1.1; 95% confidence interval [CI]: 0.85 to 1.42). The ICU mortality in the standard insulin therapy group was 31.2% (78 of 250) and 33.1% (84 of 254) in the intensive insulin therapy group (RR: 1.06; 95%CI: 0.82 to 1.36). There was no statistically significant reduction in the rate of ICU-acquired infections: 33.2% in the standard insulin therapy group compared with 27.17% in the intensive insulin therapy group (RR: 0.82; 95%CI: 0.63 to 1.07). The rate of hypoglycaemia (< or = 40 mg/dl) was 1.7% in the standard insulin therapy group and 8.5% in the intensive insulin therapy group (RR: 5.04; 95% CI: 1.20 to 21.12).


CONCLUSIONS
IIT used to maintain glucose levels within normal limits did not reduce morbidity or mortality of patients admitted to a mixed medical/surgical ICU. Furthermore, this therapy increased the risk of hypoglycaemia.


BACKGROUND
clinicaltrials.gov Identifiers: 4374-04-13031; 094-2 in 000966421.
De La Rosa
Gisela Del Carmen
Gdel C
Department of Critical Care, Hospital Pablo Tobon Uribe, Calle 78B 69-240, Medellin, Colombia. giseladlr@une.net.co
Donado
Jorge Hernando
JH
Restrepo
Alvaro Humberto
AH
Quintero
Alvaro Mauricio
AM
González
Luis Gabriel
LG
Saldarriaga
Nora Elena
NE
Bedoya
Marisol
M
Toro
Juan Manuel
JM
Velásquez
Jorge Byron
JB
Valencia
Juan Carlos
JC
Arango
Clara Maria
CM
Aleman
Pablo Henrique
PH
Vasquez
Esdras Martin
EM
Chavarriaga
Juan Carlos
JC
Yepes
Andrés
A
Pulido
William
W
Cadavid
Carlos Alberto
CA
D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000378:metabolism; D003422:Critical Care / Q000379:methods* / Q000592:standards*; D005260:Female; D038321:Glycemic Index / Q000502:physiology*; D006760:Hospitalization; D006801:Humans; D007328:Insulin / Q000097:blood; D007362:Intensive Care Units / Q000592:standards*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies
D001786:Blood Glucose; D007328:Insulin
Intensive Care Med. 2004 Aug;30(8):1685-8
15148570
AACN Clin Issues. 2004 Jan-Mar;15(1):45-62
14767364
Intensive Care Med. 2006 Mar;32(3):435-8
16477415
N Engl J Med. 2001 Nov 8;345(19):1359-67
11794168
N Engl J Med. 2006 Feb 2;354(5):449-61
16452557
Best Pract Res Clin Endocrinol Metab. 2001 Dec;15(4):533-51
11800522
Mayo Clin Proc. 2004 Aug;79(8):992-1000
15301325
J Clin Endocrinol Metab. 2002 Mar;87(3):978-82
11889147
Intensive Care Med. 1996 Jul;22(7):707-10
8844239
Anesthesiology. 2006 Aug;105(2):244-52
16871057
N Engl J Med. 2008 Jan 10;358(2):125-39
18184958
Mayo Clin Proc. 2003 Dec;78(12):1471-8
14661676
Arch Intern Med. 2004 Oct 11;164(18):2005-11
15477435
Crit Care Med. 2005 Dec;33(12):2772-7
16352959
Crit Care Clin. 2001 Jan;17(1):107-24
11219223
Crit Care Med. 1985 Oct;13(10):818-29
3928249