Intensive Insulin Therapy After Severe Traumatic Brain Injury: A Randomized Clinical Trial

Bilotta, Federico; Caramia, Remo; Černak, Ibolja; Paoloni, Francesca; Doronzio, Andrea; Cuzzone, Vincenzo; Santoro, Antonio; Rosa, Giovanni

doi:10.1007/s12028-008-9084-9

Cited by 183 publications

(137 citation statements)

References 33 publications

(33 reference statements)

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“…Overall, 28 articles were excluded ( Figure 1). We included 26 trials [8][9][10][11][12][13]18,[22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40] in the meta-analysis.…”

Section: Literature Searchmentioning

confidence: 99%

See 1 more Smart Citation

Intensive insulin therapy and mortality among critically ill patients: a meta-analysis including NICE-SUGAR study data

Griesdale¹,

Souza²,

Dam³

et al. 2009

Canadian Medical Association Journal

962

614

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Section: Literature Searchmentioning

confidence: 99%

“…[22][23][24][26][27][28]31,34,37 One trial randomly assigned patients to 1 of 3 levels of glycemic control: 4.4-6.1 mmol/L, 6.7-8.3 mmol/L or 10.0-11.1 mmol/L. 29 Given our selection criteria of a target glucose level of 8.3 mmol/L or less, we combined data from the 2 intervention arms for our primary mortality analysis.…”

Section: Study Characteristicsmentioning

confidence: 99%

Intensive insulin therapy and mortality among critically ill patients: a meta-analysis including NICE-SUGAR study data

Griesdale¹,

Souza²,

Dam³

et al. 2009

Canadian Medical Association Journal

962

614

View full text Add to dashboard Cite

“…Our analysis included 14,495 patients from 27 studies 128, 330, 331, 332, 337, 338, 339, 340, 341, 342, 343, 344, 345, 346, 347, 348, 349, 350, 351, 352, 353, 354, 355, 356, 357, 358, 359. None of the studies were especially prone to bias.…”

Section: Cq14: Blood Glucose Managementmentioning

confidence: 99%

The Japanese Clinical Practice Guidelines for Management of Sepsis and Septic Shock 2016 (J‐SSCG2016)

Nishida

Ogura

Egi

et al. 2018

Acute Medicine & Surgery

157

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Background and PurposeThe Japanese Clinical Practice Guidelines for Management of Sepsis and Septic Shock 2016 (J‐SSCG 2016), a Japanese‐specific set of clinical practice guidelines for sepsis and septic shock created jointly by the Japanese Society of Intensive Care Medicine and the Japanese Association for Acute Medicine, was first released in February 2017 in Japanese. An English‐language version of these guidelines was created based on the contents of the original Japanese‐language version.MethodsMembers of the Japanese Society of Intensive Care Medicine and the Japanese Association for Acute Medicine were selected and organized into 19 committee members and 52 working group members. The guidelines were prepared in accordance with the Medical Information Network Distribution Service (Minds) creation procedures. The Academic Guidelines Promotion Team was organized to oversee and provide academic support to the respective activities allocated to each Guideline Creation Team. To improve quality assurance and workflow transparency, a mutual peer review system was established, and discussions within each team were open to the public. Public comments were collected once after the initial formulation of a clinical question (CQ), and twice during the review of the final draft. Recommendations were determined to have been adopted after obtaining support from a two‐thirds (>66.6%) majority vote of each of the 19 committee members.ResultsA total of 87 CQs were selected among 19 clinical areas, including pediatric topics and several other important areas not covered in the first edition of the Japanese guidelines (J‐SSCG 2012). The approval rate obtained through committee voting, in addition to ratings of the strengths of the recommendation and its supporting evidence were also added to each recommendation statement. We conducted meta‐analyses for 29 CQs. Thirty seven CQs contained recommendations in the form of an expert consensus due to insufficient evidence. No recommendations were provided for 5 CQs.ConclusionsBased on the evidence gathered, we were able to formulate Japanese‐specific clinical practice guidelines that are tailored to the Japanese context in a highly transparent manner. These guidelines can easily be used not only by specialists, but also by non‐specialists, general clinicians, nurses, pharmacists, clinical engineers, and other healthcare professionals.

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“…14 Several additional trials conducted across a range of critically ill populations have also failed to show a survival benefit and have shown an increased risk of hypoglycemia with IIT. 13,[15][16][17][18] The key concern from these observations is defining what constitutes the optimal and safest target for BG in critically ill patients to both improve clinical outcomes and prevent the adverse consequences of hypoglycemia. 19 Finally and equally concerning, the evidence from the two IIT trials by Van den Berghe et al, representing the vast majority of patients subjected to intervention with IIT, had rapid and wide dissemination into clinical practice guidelines and incorporation as a benchmark quality indicator in critical care, leading to the development of numerous industry-funded applications (e.g., monitoring devices, specialized software).…”

Section: Commentarymentioning

confidence: 99%

“…Importantly, no additional benefits of applying IIT were observed in this trial, including no observed differences in duration of mechanical ventilation, need for or duration of RRT, reduction in new organ dysfunction, positive blood cultures, rate of blood transfusion, ICU length of stay, or duration of hospitalization. Therapy with IIT was, however, associated with a marked increased risk of severe hypoglycemia (NNH 16, 95 CI, [14][15][16][17][18][19]. For every 16 critically ill patients receiving IIT, one additional patient would suffer an episode of severe hypoglycemia beyond that expected from conservative BG control.…”

Section: External Validitymentioning

confidence: 99%

Intensive vs conventional blood glucose control in critically ill patients

Bagshaw

Hoste

Jacka

2009

Can J Anesth/J Can Anesth

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Article appraised Critical care issueHyperglycemia is common during critical illness and has been identified as a modifiable risk factor for increased morbidity and mortality in critically ill patients. Data from selected clinical trials suggest that intensive insulin therapy (IIT) and tight glycemic control (TGC) achieve a clinical benefit when targeting blood glucose (BG) in the range of 4.4-6.1 mmol Á L -1 . However, reports of recently conducted randomized trials have shown conflicting results. Consequently, the NICE-SUGAR (Normoglycaemia in Intensive Care Evaluation and Survival Using Glucose Algorithm Regulation) trial was designed as a pragmatic multi-national multi-centre randomized ''effectiveness'' trial to evaluate the impact of IIT to achieve TGC on 90-day all cause mortality and several secondary morbidity outcomes. The NICE-SUGAR trial aimed to resolve existing concerns about the applicability of IIT to achieve TGC in critical illness. This article considers the NICE-SUGAR trial and discusses its key findings in the context of the published literature.As the optimum target range for blood glucose (BG) in critically ill patients remains unclear, the objective of this study was to evaluate whether intensive glucose control in critical illness is associated with improved clinical outcomes. The design was a multi-national multi-centre randomized controlled trial. The setting involved 42 participating intensive care units (ICUs) across Australia, New Zealand, Canada, and the United States. Critically ill adult subjects met the eligibility requirements if, within 24 hr after admission to an ICU, they were expected to require treatment in the ICU for three or more consecutive days. Subjects were randomized to receive either intensive glucose control with a target blood glucose range of 4.5-6.0 mmol Á L -1 or conventional glucose control with a target blood glucose range of 10.0 mmol Á L -1 or less. The primary endpoint was allcause mortality 90 days after randomization. Of the 6,104 subjects who were randomized, 3,054 patients were randomized to undergo intensive glucose control and 3,050 patients received conventional glucose management. Data with regard to the primary outcome at day 90 were available for over 98% of the subjects evaluated. The two groups had similar characteristics at baseline. The authors reported that 829 patients (27.5%) in the intensive-control group and 751 (24.9%) patients in the conventional-control group died (odds ratio [OR] for intensive control, 1.14; 95% confidence intervals [CI], 1.02-1.28; P = 0.02). The treatment effect was similar when comparing operative (surgical) patients and non-operative (medical) patients (odds ratio for death in the intensive-control group, 1.31 and 1.07, respectively; P = 0.10). Severe hypoglycemia, defined as a blood glucose level \2.2 mmol Á L -1 was reported in 206 (6.8%) of patients in the intensive-control group and 15 (0.5%) of patients in the conventional-control group (P \ 0.001). The groups were found to be similar regarding the median

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Intensive Insulin Therapy After Severe Traumatic Brain Injury: A Randomized Clinical Trial

Cited by 183 publications

References 33 publications

Intensive insulin therapy and mortality among critically ill patients: a meta-analysis including NICE-SUGAR study data

Intensive insulin therapy and mortality among critically ill patients: a meta-analysis including NICE-SUGAR study data

The Japanese Clinical Practice Guidelines for Management of Sepsis and Septic Shock 2016 (J‐SSCG2016)

Intensive vs conventional blood glucose control in critically ill patients

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