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

Sponsor

SepNet - Critical Care Trials Group (Other)

Overall Status

Completed

CT.gov ID

NCT00135473

Collaborator

German Federal Ministry of Education and Research (Other), B. Braun Melsungen AG (Industry), Novo Nordisk A/S (Industry), HemoCue Gmbh, Großostheim, Germany (Other)

600

Enrollment

Locations

Duration (Months)

37.5

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Severe Sepsis Septic Shock	Drug: 10% Hemohes® (10% Hydroxyethyl starch) Drug: Sterofundin® (Ringer lactate solution) Drug: Actrapid® (Insulin)	Phase 3

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (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

Study Start Date :

Apr 1, 2003

Study Completion Date :

Sep 1, 2005

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Universitätsklinikum der RWTH Aachen	Aachen	Germany	52074
2	Klinikum Augsburg	Augsburg	Germany	86156
3	VIVANTES Klinikum Neukölln II	Berlin	Germany	12313
4	Charité I Campus Virchow-Klinikum	Berlin	Germany	13353
5	Städtisches Klinikum Brandenburg GmbH	Brandenburg	Germany	14770
6	Krankenhaus Dresden Friedrichstadt	Dresden	Germany	01067
7	Universität Carl-Gustav-Carus	Dresden	Germany	01067
8	HELIOS Klinikum Erfurt	Erfurt	Germany	99089
9	Universität Erlangen-Nürnberg	Erlangen	Germany	91054
10	Ernst-Moritz-Arndt-Universität	Greifswald	Germany	17487
11	Georg-August-Universität Göttingen	Göttingen	Germany	37075
12	Martin-Luther-Universität Halle/Wittenberg	Halle/Saale	Germany	06097
13	Medizinische Hochschule Hannover	Hannover	Germany	30625
14	Universitätsklinikum Jena	Jena	Germany	07743
15	Universitätsklinikum Kiel	Kiel	Germany	24105
16	Universitätsklinikum Leipzig	Leipzig	Germany	04103