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

Septic Shock Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00135473
• Other study ID #: SEPNET-200304
• Secondary ID: 01 KI 0106 (BMBF
• Status: Completed
• Phase: Phase 3
• First received: August 24, 2005
• Last updated: February 10, 2016
• Start date: April 2003
• Est. completion date: September 2005

Study information

• Verified date: February 2016
• Source: German Competence Network Sepsis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sepsis
• Septic Shock
• Severe Sepsis
• Shock, Septic
• Toxemia

Intervention

Drug:
• 10% Hemohes® (10% Hydroxyethyl starch)

• Sterofundin® (Ringer lactate solution)

• Actrapid® (Insulin)

Locations

Country	Name	City	State
Germany	Universitätsklinikum der RWTH Aachen	Aachen
Germany	Klinikum Augsburg	Augsburg
Germany	Charité I Campus Virchow-Klinikum	Berlin
Germany	VIVANTES Klinikum Neukölln II	Berlin
Germany	Städtisches Klinikum Brandenburg GmbH	Brandenburg
Germany	Krankenhaus Dresden Friedrichstadt	Dresden
Germany	Universität Carl-Gustav-Carus	Dresden
Germany	HELIOS Klinikum Erfurt	Erfurt
Germany	Universität Erlangen-Nürnberg	Erlangen
Germany	Georg-August-Universität Göttingen	Göttingen
Germany	Ernst-Moritz-Arndt-Universität	Greifswald
Germany	Martin-Luther-Universität Halle/Wittenberg	Halle/Saale
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Universitätsklinikum Jena	Jena
Germany	Universitätsklinikum Kiel	Kiel
Germany	Universitätsklinikum Leipzig	Leipzig

Sponsors (5)

Lead Sponsor	Collaborator
German Competence Network Sepsis	B. Braun Melsungen AG, German Federal Ministry of Education and Research, HemoCue Gmbh, Großostheim, Germany, Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality (28 day)
Primary	Morbidity (mean sepsis-related organ failure assessment [SOFA] score during intensive care unit length of stay [ICU LOS])
Secondary	Frequency of acute kidney failure
Secondary	Time until hemodynamic stabilization
Secondary	Frequency of therapy with vasopressors (in days)
Secondary	Course of SOFA sub-scores
Secondary	Frequency of hemorrhages under hydroxyethyl starch (HES) therapy
Secondary	Frequency of hypoglycemia under intensive insulin therapy
Secondary	Frequency of critical illness polyneuropathy (CIP)
Secondary	90 day Mortality

External Links

•   Click here for more information about the VISEP study by SepNet