Intensive insulin therapy and pentastarch resuscitation in severe sepsis
Open accessAbstract
BACKGROUND: The role of intensive insulin therapy in patients with severe sepsis is uncertain. Fluid resuscitation improves survival among patients with septic shock, but evidence is lacking to support the choice of either crystalloids or colloids. METHODS: In a multicenter, two-by-two factorial trial, we randomly assigned patients with severe sepsis to receive either intensive insulin therapy to maintain euglycemia or conventional insulin therapy and either 10% pentastarch, a low-molecular-weight hydroxyethyl starch (HES 200/0.5), or modified Ringer's lactate for fluid resuscitation. The rate of death at 28 days and the mean score for organ failure were coprimary end points. RESULTS: The trial was stopped early for safety reasons. Among 537 patients who could be evaluated, the mean morning blood glucose level was lower in the intensive-therapy group (112 mg per deciliter [6.2 mmol per liter]) than in the conventional-therapy group (151 mg per deciliter [8.4 mmol per liter], P<0.001). However, at 28 days, there was no significant difference between the two groups in the rate of death or the mean score for organ failure. The rate of severe hypoglycemia (glucose level, < or = 40 mg per deciliter [2.2 mmol per liter]) was higher in the intensive-therapy group than in the conventional-therapy group (17.0% vs. 4.1%, P<0.001), as was the rate of serious adverse events (10.9% vs. 5.2%, P=0.01). HES therapy was associated with higher rates of acute renal failure and renal-replacement therapy than was Ringer's lactate. CONCLUSIONS: The use of intensive insulin therapy placed critically ill patients with sepsis at increased risk for serious adverse events related to hypoglycemia. As used in this study, HES was harmful, and its toxicity increased with accumulating doses. (ClinicalTrials.gov number, NCT00135473.)
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The basal-bolus regimen is labor intensive, needs multiple daily injections, and carries hypoglycemia risk affecting 10% to 30% of noncritically ill patients.
“Though effective, the basal-bolus regimen is labor intensive, requires several injections per day, and is associated with risk of hypoglycemia, affecting up to 10% to 30% of noncritically ill persons.102,1333”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [102]
The Safety End Points section reports a hypoglycemia risk with intensive insulin therapy: severe episodes occurred in 17.0% of patients versus 4.1% receiving conventional therapy. But the Insulin Therapy section describes continuous infusions in critically ill patients with sepsis, not a basal-bolus regimen in noncritically ill people. The paper does not establish the claimed multiple-injection burden or a 10%–30% rate for that population. (LLM, conf=0.86)
Experimental — accuracy not yet measuredAggressive lowering of glycemia in the ICU may be associated with increased mortality.
“However, subsequent studies showed that such aggressive lowering of glycemia in the ICU is not uniformly beneficial, markedly increases the risk of severe hypoglycemia, and may be associated with increased mortality (70–74).”
From Hypoglycemia and Diabetes: A Report of a Workgroup of the American Diabetes Association and The Endocrine Society (2013) · cites this paper as [70]
The Discussion reports that intensive insulin therapy increased severe hypoglycemia, and the Mortality section identifies hypoglycemia as a risk factor for death. But the trial found no significant mortality difference between treatment groups and did not identify intensive insulin therapy itself as an independent risk factor for death. Page numbers were not supplied in our copy. (LLM, conf=0.85)
Experimental — accuracy not yet measuredAggressive lowering of glycemia in the ICU markedly increases the risk of severe hypoglycemia.
“However, subsequent studies showed that such aggressive lowering of glycemia in the ICU is not uniformly beneficial, markedly increases the risk of severe hypoglycemia, and may be associated with increased mortality (70–74).”
From Hypoglycemia and Diabetes: A Report of a Workgroup of the American Diabetes Association and The Endocrine Society (2013) · cites this paper as [70]
Aggressive lowering of glycemia in the ICU is not uniformly beneficial.
“However, subsequent studies showed that such aggressive lowering of glycemia in the ICU is not uniformly beneficial, markedly increases the risk of severe hypoglycemia, and may be associated with increased mortality (70–74).”
From Hypoglycemia and Diabetes: A Report of a Workgroup of the American Diabetes Association and The Endocrine Society (2013) · cites this paper as [70]
Experimental — accuracy not yet measuredTwo randomised controlled trials conducted in critically ill patients in the intensive care unit setting identified severe hypoglycaemia as an independent risk factor for mortality.
“Two randomised controlled trials conducted in critically ill patients in the intensive care unit setting also identified severe hypoglycaemia as an independent risk factor for mortality.25 26”
From The association between symptomatic, severe hypoglycaemia and mortality in type 2 diabetes: Retrospective epidemiological analysis of the ACCORD study (2010) · cites this paper as [25]
People without preexisting diabetes or stress hyperglycemia have a higher incidence of more complications after heart surgery.
“Those without preexisting DM or stress hyperglycemia have a higher incidence of more postheart surgery complications.91,100–103”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [102]
The Discussion (page unavailable) discusses postoperative survival in cardiac surgical patients receiving intensive insulin therapy, not complication rates by preexisting diabetes or stress-hyperglycemia status. Searches for those conditions and post-heart-surgery complications found no passage addressing the claimed comparison. (LLM, conf=0.76)
Experimental — accuracy not yet measuredMoving from hospital to ambulatory or subacute care is a high-risk period for medication errors and also a chance to improve glycemic control and avoid clinical inertia.
“The transition of persons from the hospital to ambulatory or subacute settings is a high-risk period for medication errors, but also an opportunity to improve glycemic control, avoiding what is often termed clinical inertia.102,1285,1286,1380”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [102]
The Nutrition and Blood Glucose Control and Safety End Points sections report glucose levels and hypoglycemia during intensive care for severe sepsis. Searches for hospital-to-ambulatory transitions, medication errors, discharge, and clinical inertia found no passage addressing the claimed risks or opportunity at that transition. Page numbers were unavailable in our copy. (LLM, conf=0.76)
Experimental — accuracy not yet measuredAdipose tissue utilizes 4.5 kcal/kg/day and muscle 13 kcal/kg/day.
“Adipose tissue utilizes 4.5 kcal/kg/day and muscle 13 kcal/kg/day.(352).”
From ESPEN guideline on clinical nutrition in the intensive care unit. (2019) · cites this paper as [352]
The Nutrition and Blood Glucose Control section reports patients’ nutritional intake and insulin treatment, while the Figure 1 description reports caloric intake; neither gives energy-use rates for adipose tissue or muscle. Searches for the quoted rates and for tissue-specific energy expenditure found no passage addressing the claim. Page numbers were unavailable in our copy. (LLM, conf=0.74)
Experimental — accuracy not yet measuredIn a single centre study, targeting blood glucose to 80-110 mg/dL reduced ICU mortality, but this finding was not reproduced in subsequent multi-centre RCTs.
“In a single centre study, targeting blood glucose to 80-110 mg/dL reduced ICU mortality [513], however this finding was not reproduced in subsequent multi-centre RCTs [514, 515].”
From Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021 (2021) · cites this paper as [514]
Intensified insulin therapy in critically ill patients is associated with more severe hypoglycemic events than less aggressive glycemic control protocols.
“In addition, intensified insulin therapy in critically-ill patients has been shown to be associated with a higher rate of severe hypoglycemic events than less aggressive glycemic control protocols.7–10”
From A comparison study of continuous insulin infusion protocols in the medical intensive care unit: Computer-guided vs. Standard column-based algorithms (2010) · cites this paper as [8]
The rate of severe hypoglycemia (<40 mg/dL) in this trial was lower than rates reported in recent international trials of intensive glycemic control.
“The rate of severe hypoglycemic events (<40 mg/dL) observed in both arms of our trial was significantly lower than those reported in recent international trials of intensive glycemic control.3,4,8”
From A comparison study of continuous insulin infusion protocols in the medical intensive care unit: Computer-guided vs. Standard column-based algorithms (2010) · cites this paper as [8]
The overall rate of severe hypoglycemic events in international trials ranged from 5% to 28.6%.
“The overall rate of severe hypoglycemic events in international trials ranged between 5% to 28.6%.3,4,7,8,18,19”
From A comparison study of continuous insulin infusion protocols in the medical intensive care unit: Computer-guided vs. Standard column-based algorithms (2010) · cites this paper as [8]
Aggressive lowering of glycemia in the ICU markedly increases the risk of severe hypoglycemia.
“However, subsequent studies showed that such aggressive lowering of glycemia in the ICU is not uniformly bene fi cial, markedly increases the risk of severe hypoglycemia, and may be associated with increased mortality (70 -74).”
From Hypoglycemia and Diabetes: A Report of a Workgroup of the American Diabetes Association and The Endocrine Society (2013) · cites this paper as [70]
Aggressive lowering of glycemia in the ICU is not uniformly beneficial.
“However, subsequent studies showed that such aggressive lowering of glycemia in the ICU is not uniformly bene fi cial, markedly increases the risk of severe hypoglycemia, and may be associated with increased mortality (70 -74).”
From Hypoglycemia and Diabetes: A Report of a Workgroup of the American Diabetes Association and The Endocrine Society (2013) · cites this paper as [70]
Aggressive lowering of glycemia in the ICU may be associated with increased mortality.
“However, subsequent studies showed that such aggressive lowering of glycemia in the ICU is not uniformly bene fi cial, markedly increases the risk of severe hypoglycemia, and may be associated with increased mortality (70 -74).”
From Hypoglycemia and Diabetes: A Report of a Workgroup of the American Diabetes Association and The Endocrine Society (2013) · cites this paper as [70]
In several studies of critically ill medical patients, the incidence of severe hypoglycemia (blood glucose <40 mg/dl) was approximately threefold greater in intensively treated patients.
“However, in several studies of critically ill medical patients (330,331,333), the incidence of severe hypoglycemia (blood glucose <40 mg/dl) was approximately threefold greater in intensively treated patients.”
From Standards of Medical Care in Diabetes—2009 (2009) · cites this paper as [331]
In another study using a similar intervention targeting a blood glucose range of 4.4-6.1 mmol in patients admitted with sepsis, no difference in mortality from the conventionally treated group was observed.
“In another study using a similar intervention targeting a blood glucose range of 4.4–6.1 mmol in patients admitted with sepsis, no difference in mortality from the conventionally treated group was observed.”
From Standards of Medical Care in Diabetes—2009 (2009) · cites this paper as [331]
There were more episodes of hypoglycemia (blood glucose <40 mg/dl) and more serious adverse events in the group receiving intensive insulin therapy in the sepsis study.
“There were more episodes of hypoglycemia, defined as a blood glucose <40 mg/dl (2.2 mmol/l), and more serious adverse events in the group receiving intensive insulin therapy (331).”
From Standards of Medical Care in Diabetes—2009 (2009) · cites this paper as [331]
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- Authors
- Brunkhorst, F. M., Engel, C., Bloos, F., Meier-Hellmann, A., Ragaller, M., Weiler, N., Moerer, O., Gruendling, M., Oppert, M., Grond, S., Olthoff, D., Jaschinski, U., John, S., Rossaint, R., Welte, T., Schaefer, M., Kern, P., Kuhnt, E., Kiehntopf, M., Hartog, C., Natanson, C., Loeffler, M., & Reinhart, K.
- Affiliations
- Friedrich Schiller University Jena (DE)
- Leipzig University (DE)
- Technische Universität Dresden (DE)
- University Hospital Schleswig-Holstein (DE)
- University of Göttingen (DE)
- Charité – Universitätsmedizin Berlin (DE)
- Martin Luther University Halle-Wittenberg (DE)
- University Hospital Leipzig (DE)
- Otto-von-Guericke-Universität Magdeburg (DE)
- Friedrich-Alexander-Universität Erlangen-Nürnberg (DE)
- Universitätsklinikum Aachen (DE)
- Medizinische Hochschule Hannover (DE)
- Krankenhaus Dresden-Friedrichstadt (DE)
- National Institutes of Health (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2008-01-10
- Volume
- 358
- Issue
- 2
- Pages
- 125-139
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2148706741
- Cited by
- 2,921
- References
- 37
- Citations by year
- 2026: 30 · 2025: 47 · 2024: 47 · 2023: 70 · 2022: 68 · 2021: 95 · 2020: 75 · 2019: 85 · 2018: 116 · 2017: 114 · 2016: 158 · 2015: 195 · 2014: 218 · 2013: 245 · 2012: 251
- FWCI
- 265.15
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- GoeScholar The Publication Server of the Georg-August-Universität Göttingen (Georg-August-Universität Göttingen) (submittedVersion, cc-by)
- RWTH Publications (RWTH Aachen) (submittedVersion)
- OPUS (Augsburg University) (submittedVersion)
- Funders
- Massachusetts Medical Society
- Friedrich-Schiller-Universität Jena
- Bundesministerium für Bildung und Forschung (01KI0106)
- Hebrew University of Jerusalem
- Novo Nordisk
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hyperglycemia and glycemic control in critically ill and hospitalized patients
- Health Sciences › Medicine › Epidemiology › Sepsis Diagnosis and Treatment
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Keywords
- intensive insulin therapy, pentastarch, hydroxyethyl starch, fluid resuscitation, severe sepsis, septic shock, normoglycemia, hypoglycemia, lactated Ringer's solution, acute kidney injury, organ failure, mortality
- MeSH terms
- Ringer's Solution, Aged, Combined Modality Therapy, Dose-Response Relationship, Drug, Female, Fluid Therapy, Humans, Hydroxyethyl Starch Derivatives, Hypoglycemia, Hypoglycemic Agents, Infusions, Intravenous, Insulin, Isotonic Solutions, Male, Middle Aged, Risk Factors, Multivariate Analysis, Critical Illness, Treatment Failure, Sepsis, Kaplan-Meier Estimate, Acute Kidney Injury
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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