Abstract
Question: Is the use of intensive insulin therapy compared with conventional therapy (on the basis of Leuven titration protocol) and hydroxyethyl starch (HES) compared with Ringer lactate effective and safe in patients with severe sepsis or septic shock? Design: Randomized open-label controlled trial. Setting: Multicentre (18 aca - demic tertiary hospitals in Germany). Patients: Six hundred patients with a diagnosis of severe sepsis or septic shock. Patients were deemed to be eligible if the onset of the syndrome was less than 24 hours before admission to the intensive care unit (ICU) or less than 24 hours after admission if the condition developed in the ICU. Interventions: Patients were randomly assigned in a 2 × 2 factorial design to receive either conventional (target blood glucose 180°C200 mg/dL; n = 326) or intensive insulin therapy (target blood glucose 80°C100 mg/dL; n = 274) or HES (n = 207) or Ringer lactate (n = 303). Main outcomes: Death from any cause at 28 days and morbidity measured by the mean score on the Sequential Organ Failure Assessment (SOFA) on a scale ranging from 0 to 4 for each of 6 organ systems with an aggregate score of 0°C24 and higher scores indicating more severe organ dysfunction. Results: The mean morning blood glucose level was lower in the intensive therapy group (112 mg/dL [6.2 mmol/L]) than in the conventional therapy group (151 mg/dL [8.4 mmol/L]; p ≤ 0.001). However, at 28 days there were no significant differences between the groups in the rate of death or mean score for organ failure. The rate of severe hypoglycemia (glucose level ≤ 40 mg/dL [2.2 mmol/L]) was higher in the intensive therapy group than in the conventional therapy group (17% v. 4.1%; p ≤ 0.001), as was the rate of serious adverse events (10.9% v. 5.2%, p = 0.010). Hydroxyethyl starch therapy was associated with higher rates of acute renal failure and renal replacement therapy than Ringer lactate. Conclusion: The use of the intensive insulin therapy placed critically ill patients with sepsis at an increased risk for serious adverse events related to hypoglycemia. As used in this study, HES was harmful and its toxicity increased with accumulating doses.
| Original language | English |
|---|---|
| Pages (from-to) | 512-514 |
| Number of pages | 3 |
| Journal | Canadian Journal of Surgery |
| Volume | 52 |
| Issue number | 6 |
| Publication status | Published - Dec 1 2009 |
| Externally published | Yes |
Bibliographical note
Funding Information:Evidence Based Reviews in Surgery (EBRS) is a program jointly sponsored by the Canadian Association of General Surgeons (CAGS) and the American College of Surgeons (ACS) and is supported by an educational grant from ETHICON and ETHICON ENDO-SURGERY, both units of Johnson & Johnson Medical Products, a division of Johnson & Johnson and ETHICON Inc. and ETHICON ENDO-SURGERY Inc., divisions of Johnson & Johnson Inc. The primary objective of EBRS is to help practising surgeons improve their critical appraisal skills. During the academic year, 8 clinical articles are chosen for review and discussion. They are selected for their clinical relevance to general surgeons and because they cover a spectrum of issues important to surgeons, including causation or risk factors for disease, natural history or prognosis of disease, how to quantify disease, diagnostic tests, early diagnosis and the effectiveness of treatment. A methodological article guides the reader in critical appraisal of the clinical article. Methodological and clinical reviews of the article are performed by experts in the relevant areas and posted on the EBRS website, where they are archived indefinitely. In addition, a listserv allows participants to discuss the monthly article. Surgeons who participate in the monthly packages can obtain Royal College of Physicians and Surgeons of Canada Maintenance of Certification credits and/or continuing medical education credits for the current article only by reading the monthly articles, participating in the listserv discussion, reading the methodological and clinical reviews and completing the monthly online evaluation and multiple choice questions.
ASJC Scopus Subject Areas
- Surgery