Efficacy of Volume Substitution and Insulin Therapy in Severe Sepsis (VISEP Trial)
This study has been completed.
Sponsor:
German Competence Network Sepsis
Collaborators:
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
First received: August 24, 2005
Last updated: July 28, 2010
Last verified: February 2006
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Purpose
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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by German Competence Network Sepsis:
Primary Outcome Measures:
- Mortality (28 day)
- Morbidity (mean sepsis-related organ failure assessment [SOFA] score during intensive care unit length of stay [ICU LOS])
Secondary Outcome Measures:
- Frequency of acute kidney failure
- Time until hemodynamic stabilization
- Frequency of therapy with vasopressors (in days)
- 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
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients fulfilling the criteria of "severe sepsis" or "septic shock" according to the Society of Critical Care Medicine/American College of Chest Physicians (SCCM/ACCP) definitions not longer than 24 hours before ICU admission or 12 hours after ICU admission
Exclusion Criteria:
- Age < 18 years
- Pregnancy
- Known allergy against hydroxyethyl starch
- Pre-treatment with > 1000ml hydroxyethyl starch within 24 hours before inclusion
- Pre-existing kidney failure requiring dialysis or serum creatinine value > 320 mmol/l (3,6 mg/dl)
- Intracerebral hemorrhage
- Severe head trauma with edema
- FiO2 at time of study inclusion > 0,7
- Heart failure (New York Heart Association [NYHA] IV)
- Enrolment in another interventional study
- Immune suppression (cytostatic chemotherapy, steroid therapy, AIDS)
- Do not resuscitate (DNR) order
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00135473
Locations
| Germany | |
| Universität Carl-Gustav-Carus | |
| 01067 Dresden, Germany | |
| Krankenhaus Dresden Friedrichstadt | |
| 01067 Dresden, Germany | |
| Universitätsklinikum Leipzig | |
| 04103 Leipzig, Germany | |
| Martin-Luther-Universität Halle/Wittenberg | |
| 06097 Halle/Saale, Germany | |
| Universitätsklinikum Jena | |
| 07743 Jena, Germany | |
| VIVANTES Klinikum Neukölln II | |
| 12313 Berlin, Germany | |
| Charité I Campus Virchow-Klinikum | |
| 13353 Berlin, Germany | |
| Städtisches Klinikum Brandenburg GmbH | |
| 14770 Brandenburg, Germany | |
| Ernst-Moritz-Arndt-Universität | |
| 17487 Greifswald, Germany | |
| Universitätsklinikum Kiel | |
| 24105 Kiel, Germany | |
| Medizinische Hochschule Hannover | |
| 30625 Hannover, Germany | |
| Georg-August-Universität Göttingen | |
| 37075 Göttingen, Germany | |
| Universitätsklinikum der RWTH Aachen | |
| 52074 Aachen, Germany | |
| Klinikum Augsburg | |
| 86156 Augsburg, Germany | |
| Universität Erlangen-Nürnberg | |
| 91054 Erlangen, Germany | |
| HELIOS Klinikum Erfurt | |
| 99089 Erfurt, Germany | |
Sponsors and Collaborators
German Competence Network Sepsis
German Federal Ministry of Education and Research
B. Braun Melsungen AG
Novo Nordisk
HemoCue Gmbh, Großostheim, Germany
Investigators
| 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 |
More Information
Additional Information:
No publications provided by German Competence Network Sepsis
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00135473 History of Changes |
| Other Study ID Numbers: | SEPNET-200304, 01 KI 0106 (BMBF) |
| Study First Received: | August 24, 2005 |
| Last Updated: | July 28, 2010 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by German Competence Network Sepsis:
|
Severe sepsis septic shock volume substitution intensive insulin therapy |
colloids crystalloids outcome safety |
Additional relevant MeSH terms:
|
Sepsis Toxemia Shock Shock, Septic Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Insulin |
Hetastarch Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Plasma Substitutes Blood Substitutes Hematologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013