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

Tracking Information

First Received Date ^ICMJE

August 24, 2005

Last Updated Date

February 15, 2006

Start Date ^ICMJE

April 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Mortality (28 day)
Morbidity (mean sepsis-related organ failure assessment [SOFA] score during intensive care unit length of stay [ICU LOS])

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00135473 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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 HES therapy
Frequency of hypoglycemia under intensive insulin therapy
Frequency of critical illness polyneuropathy (CIP)
90 day Mortality

Descriptive Information

Brief Title ^ICMJE

Efficacy of Volume Substitution and Insulin Therapy in Severe Sepsis (VISEP Trial)

Official Title ^ICMJE

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

Brief Summary

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.

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study

Condition ^ICMJE

Severe Sepsis
Septic Shock

Intervention ^ICMJE

Drug: 10% Hemohes® (10% Hydroxyethyl starch)
Drug: Sterofundin® (Ringer lactate solution)
Drug: Actrapid® (Insulin)

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

600

Completion Date

September 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00135473

Responsible Party

Study ID Numbers ^ICMJE

SEPNET-200304, 01 KI 0106 (BMBF)

Study Sponsor ^ICMJE

German Competence Network Sepsis

Collaborators ^ICMJE

German Federal Ministry of Education and Research
B. Braun Melsungen AG
Novo Nordisk
HemoCue Gmbh, Großostheim, Germany

Investigators ^ICMJE

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

Information Provided By

German Competence Network Sepsis

Verification Date

February 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP