Efficacy of Volume Substitution and Insulin Therapy in Severe Sepsis (VISEP Trial) - Full Text View

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

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 III

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:

MedlinePlus related topics: Diabetes Medicines Sepsis Shock

Drug Information available for: Insulin Insulin beef Ringer's lactate Ringer's lactate solution Starch Hetastarch

U.S. FDA Resources

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

Detailed Description:

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:

Click here for more information about the VISEP study by SepNet This link exits the ClinicalTrials.gov site

No publications provided by German Competence Network Sepsis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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 February 09, 2012