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Sponsors and Collaborators: |
German Competence Network Sepsis German Federal Ministry of Education and Research B. Braun Melsungen AG Novo Nordisk HemoCue Gmbh, Großostheim, Germany |
Information provided by: | German Competence Network Sepsis |
ClinicalTrials.gov Identifier: | NCT00135473 |
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.
Condition | Intervention | Phase |
Severe Sepsis Septic Shock |
Drug: 10% Hemohes® (10% Hydroxyethyl starch) Drug: Sterofundin® (Ringer lactate solution) Drug: Actrapid® (Insulin) |
Phase III |
MedlinePlus related topics: | Sepsis |
ChemIDplus related topics: | Insulin Starch Hetastarch Lactic acid Ammonium lactate Ringer's lactate Ringer's lactate solution |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | Prospective Randomized Multicenter Study on the Influence of Colloid Vs Crystalloid Volume Resuscitation and of Intensive Vs Conventional Insulin Therapy on Outcome in Patients With Severe Sepsis and Septic Shock |
Estimated Enrollment: | 600 |
Study Start Date: | April 2003 |
Estimated Study Completion Date: | September 2005 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |||||
Klinikum Augsburg | |||||
86156 Augsburg, Germany | |||||
Ernst-Moritz-Arndt-Universität | |||||
17487 Greifswald, Germany | |||||
Universitätsklinikum Leipzig | |||||
04103 Leipzig, Germany | |||||
Martin-Luther-Universität Halle/Wittenberg | |||||
06097 Halle/Saale, Germany | |||||
Krankenhaus Dresden Friedrichstadt | |||||
01067 Dresden, Germany | |||||
Universitätsklinikum der RWTH Aachen | |||||
52074 Aachen, Germany | |||||
Universitätsklinikum Kiel | |||||
24105 Kiel, Germany | |||||
VIVANTES Klinikum Neukölln II | |||||
12313 Berlin, Germany | |||||
Universität Carl-Gustav-Carus | |||||
01067 Dresden, Germany | |||||
Georg-August-Universität Göttingen | |||||
37075 Göttingen, Germany | |||||
Universitätsklinikum Jena | |||||
07743 Jena, Germany | |||||
HELIOS Klinikum Erfurt | |||||
99089 Erfurt, Germany | |||||
Charité I Campus Virchow-Klinikum | |||||
13353 Berlin, Germany | |||||
Universität Erlangen-Nürnberg | |||||
91054 Erlangen, Germany | |||||
Universität Erlangen-Nürnberg | |||||
91054 Erlangen, Germany | |||||
Medizinische Hochschule Hannover | |||||
30625 Hannover, Germany | |||||
Städtisches Klinikum Brandenburg GmbH | |||||
14770 Brandenburg, Germany |
German Competence Network Sepsis |
German Federal Ministry of Education and Research |
B. Braun Melsungen AG |
Novo Nordisk |
HemoCue Gmbh, Großostheim, Germany |
Study Chair: | Konrad Reinhart, MD | F.-Schiller-University Jena, Germany |
Study Director: | Thomas Deufel, MD | F.-Schiller-University Jena, Germany |
Study Director: | Markus Löffler, MD | University of Leipzig |
Click here for more information about the VISEP study by SepNet 
  |
Study ID Numbers: | SEPNET-200304, 01 KI 0106 (BMBF) |
First Received: | August 24, 2005 |
Last Updated: | February 15, 2006 |
ClinicalTrials.gov Identifier: | NCT00135473 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
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