Effects of tight computerized glucose control on neurological outcome in severely brain injured patients: a multicenter sub-group analysis of the randomized-controlled open-label CGAO-REA study

Cinotti, Raphaël; Ichai, Carole; Orban, Jean-Christophe; Kalfon, Pierre; Feuillet, Fanny; Roquilly, Antoine; Riou, Bruno; Blanlœil, Y.; Asehnoune, Karim; Rozec, Bertrand

doi:10.1186/s13054-014-0498-9

Cited by 32 publications

(27 citation statements)

References 43 publications

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“…1 In traumatic brain injury (TBI) research, there is currently a drive towards standardizing data collection using a common set of measures which can be used to provide a multidimensional description of outcome. [4][5][6][7][8][9] At its simplest, multidimensional assessment means going beyond using a single endpoint to include two or more outcome domains. Multiple outcome domains are relevant to TBI, including global functional outcome, cognition, health-related quality of life, TBI symptoms, and psychological status.…”

Section: Introductionmentioning

confidence: 99%

Randomized Controlled Trials in Adult Traumatic Brain Injury: A Systematic Review on the Use and Reporting of Clinical Outcome Assessments

Horton

Rhodes

Wilson

2018

Journal of Neurotrauma

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As part of efforts to improve study design, the use of outcome measures in randomized controlled trials (RCTs) in traumatic brain injury (TBI) is receiving increasing attention. This review aimed to assess how clinical outcome assessments (COAs) have been used and reported in RCTs in adult TBI. Systematic literature searches were conducted to identify medium to large (n ≥ 100) acute and post-acute TBI trials published since 2000. Data were extracted independently by two reviewers using a set of structured templates. Items from the Consolidated Standards of Reporting Trials (CONSORT) 2010 Statement and CONSORT patient-reported outcomes (PROs) extension were used to evaluate reporting quality of COAs. Glasgow Outcome Scale/Extended (GOS/GOSE) data were extracted using a checklist developed specifically for the review. A total of 126 separate COAs were identified in 58 studies. The findings demonstrate heterogeneity in the use of TBI outcomes, limiting comparisons and meta-analyses of RCT findings. The GOS/GOSE was included in 39 studies, but implemented in a variety of ways, which may not be equivalent. Multi-dimensional outcomes were used in 30 studies, and these were relatively more common in rehabilitation settings. The use of PROs was limited, especially in acute study settings. Quality of reporting was variable, and key information concerning COAs was often omitted, making it difficult to know how precisely outcomes were assessed. Consistency across studies would be increased and future meta-analyses facilitated by (a) using common data elements (CDEs) recommendations for TBI outcomes and (b) following CONSORT guidelines when publishing RCTs.

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Section: Introductionmentioning

confidence: 99%

Randomized Controlled Trials in Adult Traumatic Brain Injury: A Systematic Review on the Use and Reporting of Clinical Outcome Assessments

Horton

Rhodes

Wilson

2018

Journal of Neurotrauma

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“…The latter effect is consistent with reports that post-TBI insulin treatment to lower glucose in humans can lead to detrimental hypoglycemia, increased cerebral metabolic crisis and peri-ischemic cortical depolarizations (Bilotta et al, 2008, Hopwood et al, 2005, Oddo et al, 2008, Vespa et al, 2006, 2012). However, a recent multi-center trial found no difference in neurological outcome (at 28 or 90 days) for patients sustaining severe TBI who were treated with insulin to target blood glucose between 5.5 to 9 mmol/L compared to those with a blood glucose target of 4.4 to 6 mmol/L (Cinotti et al, 2014). …”

Section: Discussionmentioning

confidence: 99%

Glucose administration after traumatic brain injury exerts some benefits and no adverse effects on behavioral and histological outcomes

et al. 2015

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The impact of hyperglycemia after traumatic brain injury (TBI), and even the administration of glucose–containing solutions to head injured patients, remains controversial. In the current study adult male Sprague-Dawley rats were tested on behavioral tasks and then underwent surgery to induce sham injury or unilateral controlled cortical impact (CCI) injury followed by injections (i.p.) with either a 50% glucose solution (Glc; 2 g/kg) or an equivalent volume of either 0.9% or 8% saline (Sal) at 0, 1, 3 and 6 h post-injury. The type of saline treatment did not significantly affect any outcome measures, so these data were combined. Rats with CCI had significant deficits in beam-walking traversal time and rating scores (p’s <0.001 versus sham) that recovered over test sessions from 1 to 13 days post-injury (p’s <0.001), but these beam-walking deficits were not affected by Glc versus Sal treatments. Persistent post-CCI deficits in forelimb contraflexion scores and forelimb tactile placing ability were also not differentially affected by Glc or Sal treatments. However, deficits in latency to retract the right hind limb after limb extension were significantly attenuated in the CCI-Glc group (p<0.05 versus CCI-Sal). Both CCI groups were significantly impaired in a plus maze test of spatial working memory on days 4, 9 and 14 post-surgery (p<0.001 versus sham), and there was no effect of Glc versus Sal on this cognitive outcome measure. At 15 days post-surgery the loss of cortical tissue volume (p<0.001 versus sham) was significantly less in the CCI-Glc group (30.0%; p<0.05) compared to the CCI-Sal group (35.7%). Counts of surviving hippocampal hilar neurons revealed a significant (~40%) loss ipsilateral to CCI (p<0.001 versus sham), but neuronal loss in the hippocampus was not different in the CCI-Sal and CCI-Glc groups. Taken together, these results indicate that an early elevation of blood glucose may improve some neurological outcomes and, importantly, the induction of hyperglycemia after isolated TBI did not adversely affect any sensorimotor, cognitive or histological outcomes.

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“…A subgroup analysis of patients with traumatic brain injury has also been published [21]. The study was approved by an ethical committee (Comité de Protection des Personnes, CCP de Tours, Tours, France).…”

Section: Methodsmentioning

confidence: 99%

Severe and multiple hypoglycemic episodes are associated with increased risk of death in ICU patients

Kalfon¹,

Manach²,

Ichai³

et al. 2015

Crit Care

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IntroductionIn a randomized controlled trial comparing tight glucose control with a computerized decision support system and conventional protocols (post hoc analysis), we tested the hypothesis that hypoglycemia is associated with a poor outcome, even when controlling for initial severity.MethodsWe looked for moderate (2.2 to 3.3 mmol/L) and severe (<2.2 mmol/L) hypoglycemia, multiple hypoglycemic events (n ≥3) and the other main components of glycemic control (mean blood glucose level and blood glucose coefficient of variation (CV)). The primary endpoint was 90-day mortality. We used both a multivariable analysis taking into account only variables observed at admission and a multivariable matching process (greedy matching algorithm; caliper width of 10−5 digit with no replacement).ResultsA total of 2,601 patients were analyzed and divided into three groups: no hypoglycemia (n =1,474), moderate hypoglycemia (n =874, 34%) and severe hypoglycemia (n =253, 10%). Patients with moderate or severe hypoglycemia had a poorer prognosis, as shown by a higher mortality rate (36% and 54%, respectively, vs. 28%) and decreased number of treatment-free days. In the multivariable analysis, severe (odds ratio (OR), 1.50; 95% CI, 1.36 to 1.56; P =0.043) and multiple hypoglycemic events (OR, 1.76, 95% CI, 1.31 to 3.37; P <0.001) were significantly associated with mortality, whereas blood glucose CV was not. Using multivariable matching, patients with severe (53% vs. 35%; P <0.001), moderate (33% vs. 27%; P =0.029) and multiple hypoglycemic events (46% vs. 32%, P <0.001) had a higher 90-day mortality.ConclusionIn a large cohort of ICU patients, severe hypoglycemia and multiple hypoglycemic events were associated with increased 90-day mortality.Trial registrationClinicaltrials.gov Identifier: NCT01002482. Registered 26 October 2009.

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Effects of tight computerized glucose control on neurological outcome in severely brain injured patients: a multicenter sub-group analysis of the randomized-controlled open-label CGAO-REA study

Cited by 32 publications

References 43 publications

Randomized Controlled Trials in Adult Traumatic Brain Injury: A Systematic Review on the Use and Reporting of Clinical Outcome Assessments

Randomized Controlled Trials in Adult Traumatic Brain Injury: A Systematic Review on the Use and Reporting of Clinical Outcome Assessments

Glucose administration after traumatic brain injury exerts some benefits and no adverse effects on behavioral and histological outcomes

Severe and multiple hypoglycemic episodes are associated with increased risk of death in ICU patients

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