Intensive insulin therapy in the medical ICU – not so sweet?

Citation

Van den Berghe G, Wilmer A, Hermans G, Meersseman W, Wouters PJ, Milants I, Van Wijngaerden E, Bobbaers H, Bouillon R: Intensive insulin therapy in the medical ICU. N.Engl.J.Med 2006; 354: 449-61 [1].

Background

Intensive insulin therapy reduces morbidity and mortality in patients in surgical intensive care units (ICUs), but its role in patients in medical ICUs is unknown.

Methods

Objective

To investigate the efficacy of intensive insulin therapy in medical ICU patients.

Design

Prospective, randomized, controlled trial

Setting

Medical ICU in Leuven, Belgium.

Subjects

1200 medical ICU patients anticipated to need intensive care for at least three days.

Intervention

On admission, patients were randomly assigned to strict normalization of blood glucose levels (80 to 110 mg per deciliter [4.4 to 6.1 mmol per liter]) with the use of insulin infusion or to conventional therapy (insulin administered when the blood glucose level exceeded 215 mg per deciliter [12 mmol per liter], with the infusion tapered when the level fell below 180 mg per deciliter [10 mmol per liter]).

Measurements and main results

There was a history of diabetes in 16.9 percent of the patients. In the intention-to-treat analysis of 1200 patients, intensive insulin therapy reduced blood glucose levels but did not significantly reduce in-hospital mortality (40.0 percent in the conventional-treatment group vs. 37.3 percent in the intensive-treatment group, P = 0.33). However, morbidity was significantly reduced by the prevention of newly acquired kidney injury, accelerated weaning from mechanical ventilation, and accelerated discharge from the ICU and the hospital. Although length of stay in the ICU could not be predicted on admission, among 433 patients who stayed in the ICU for less than three days, mortality was greater among those receiving intensive insulin therapy. In contrast, among 767 patients who stayed in the ICU for three or more days, inhospital mortality in the 386 who received intensive insulin therapy was reduced from 52.5 to 43.0 percent (P = 0.009) and morbidity was also reduced.

Conclusion

Intensive insulin therapy significantly reduced morbidity but not mortality among all patients in the medical ICU. Although the risk of subsequent death and disease was reduced in patients treated for three or more days, these patients could not be identified before therapy. Further studies are needed to confirm these preliminary data. (ClinicalTrials.gov number, {"type":"clinical-trial","attrs":{"text":"NCT00115479","term_id":"NCT00115479"}}NCT00115479).     

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Endoluminal operations for reflux are currently limited by the inability to visualise and manipulate structures outside the wall of the gut. This may be possible using endoscopic ultrasound (EUS). The aim of this study was to define EUS‐anatomy of structures outside the gut which influence reflux; to place stitches in the median arcuate ligament (MAL); to perform posterior gastropexy (Hill procedure) and test the feasibility of crural repair under EUS control in pigs. In survival experiments in 14 pigs, using linear array echo‐endoscopes the MAL and part of the right crus were identified and punctured with a needle, which served as a carrier for a tag and thread. These were anchored into the muscle. An endoscopic sewing device was used allowing stitches to be placed through a 2.8?mm accessory channel to any predetermined depth. New methods allowed knot‐tying and thread‐cutting through the 2.8?mm channel of the echo‐endoscope. Stitches were placed through the gastric wall into the MAL and one just beyond the wall of the lower esophageal sphincter (LES). They were tied together and locked against the gastric wall. Preoperative manometry showed a median LES pressure of 11mm/Hg and 21?mm/Hg after stitch placement (p = 0.0028). The length of the LES increased from median 2.8?cm pre‐procedure to 3.5?cm post‐procedure. At post mortem, the force to pull the tags out of the MAL was 2.8?kg median. This study shows that transgastric gastro‐esophageal reflux surgery using stitching under EUS control can significantly increase the lower oesophageal sphincter pressure in pigs.     

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Background.?Rehabilitation is highly complex, involving multiple processes, outcomes and stakeholders. The way we deliver our services and work with our clients and their families should be informed by research approaches that produce the wide range of knowledge needed. This article aims to explore the degree to which the dominant approach to ‘evidence’ (the randomised clinical trial or RCT) meets those needs and discuss alternate/additional ways of gaining evidence.

Methods.?A critical review of the literature allowing exploration of problems encountered in rehabilitation RCTs and alterative approaches.

Findings.?We discuss some problematic issues related to using RCTs in rehabilitation research (for example the large number of people excluded from trials, and the small numbers of people with some neurological conditions making RCTs non-viable). Alternative approaches are discussed including clinical practice improvement studies (sometimes called practice-based evidence or PBE), which provide data on patients treated in routine practice; qualitative research, which can provide an understanding of the users of health care services to ensure they are meeting their needs; and metasynthesis, which can be used to summarise several qualitative studies to enhance our understanding of the principles underlying service delivery. Finally, we explore how clinicians and commissioners often use evidence generated by forms of research other than the RCT.

Conclusion.?The best answers about how to enhance rehabilitation outcomes are likely to come from a combination and integration of the most appropriate methods. In conclusion, we urge for more joined up thinking, for learning from different fields so that we can develop more effective and appropriate health care and rehabilitation.     

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