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| ID | Type | Description | Link |
|---|---|---|---|
| 01 KI 0106 (BMBF) |
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| Name | Class |
|---|---|
| German Federal Ministry of Education and Research | OTHER_GOV |
| B. Braun Melsungen AG | INDUSTRY |
| Novo Nordisk A/S | INDUSTRY |
| HemoCue |
The purpose of this trial is to determine the influence of colloid versus crystalloid volume resuscitation and of intensive vs conventional insulin therapy on morbidity and mortality of patients with severe sepsis and septic shock.
Severe sepsis and septic shock have a high mortality. Research has concentrated on adjunctive sepsis therapies; the role of supportive measures is comparatively unclear. In Europe the use of colloids is widespread, but there is no evidence on the role of either crystalloid or colloid volume therapy in sepsis. Recently, a higher incidence of kidney failure in sepsis was reported after administration of colloids.
In critical illness, a significant reduction in mortality was recently achieved by strict glycemic control, however it has to be determined whether this is true and safe for patients with sepsis as well.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10% Hemohes® (10% Hydroxyethyl starch) | Drug | |||
| Sterofundin® (Ringer lactate solution) | Drug | |||
| Actrapid® (Insulin) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality (28 day) | ||
| Morbidity (mean sepsis-related organ failure assessment [SOFA] score during intensive care unit length of stay [ICU LOS]) |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of acute kidney failure | ||
| Time until hemodynamic stabilization | ||
| Frequency of therapy with vasopressors (in days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Konrad Reinhart, MD | F.-Schiller-University Jena, Germany | Study Chair |
| Thomas Deufel, MD | F.-Schiller-University Jena, Germany | Study Director |
| Markus Löffler, MD | University of Leipzig | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum der RWTH Aachen | Aachen | 52074 | Germany | |||
| Klinikum Augsburg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18184958 | Derived | Brunkhorst FM, 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; German Competence Network Sepsis (SepNet). Intensive insulin therapy and pentastarch resuscitation in severe sepsis. N Engl J Med. 2008 Jan 10;358(2):125-39. doi: 10.1056/NEJMoa070716. |
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| INDUSTRY |
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| Course of SOFA sub-scores |
| Frequency of hemorrhages under hydroxyethyl starch (HES) therapy |
| Frequency of hypoglycemia under intensive insulin therapy |
| Frequency of critical illness polyneuropathy (CIP) |
| 90 day Mortality |
| Augsburg |
| 86156 |
| Germany |
| VIVANTES Klinikum Neukölln II | Berlin | 12313 | Germany |
| Charité I Campus Virchow-Klinikum | Berlin | 13353 | Germany |
| Städtisches Klinikum Brandenburg GmbH | Brandenburg | 14770 | Germany |
| Krankenhaus Dresden Friedrichstadt | Dresden | 01067 | Germany |
| Universität Carl-Gustav-Carus | Dresden | 01067 | Germany |
| HELIOS Klinikum Erfurt | Erfurt | 99089 | Germany |
| Universität Erlangen-Nürnberg | Erlangen | 91054 | Germany |
| Georg-August-Universität Göttingen | Göttingen | 37075 | Germany |
| Ernst-Moritz-Arndt-Universität | Greifswald | 17487 | Germany |
| Martin-Luther-Universität Halle/Wittenberg | Halle | 06097 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Universitätsklinikum Jena | Jena | 07743 | Germany |
| Universitätsklinikum Kiel | Kiel | 24105 | Germany |
| Universitätsklinikum Leipzig | Leipzig | 04103 | Germany |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
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| ID | Term |
|---|---|
| D006895 | Hydroxyethyl Starch Derivatives |
| C052337 | sterofundin |
| D007328 | Insulin |
| ID | Term |
|---|---|
| D013213 | Starch |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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