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

Phase 3

Completed

• Conditions: Severe Sepsis; Septic Shock

• Registration Number: NCT00135473
• Lead Sponsor: SepNet - Critical Care Trials Group

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 Timeline

• Study Start: 2003-04
• Study First Submitted: 2005-08-24
• Study First Submitted QC: 2005-08-24
• Study First Posted: 2005-08-26
• Study Completion: 2005-09
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-10
• Last Update Posted: 2016-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)
Frequency of acute kidney failure
90 day Mortality

Trial Locations

Locations (16)

Charité I Campus Virchow-Klinikum; 🇩🇪 Berlin, Germany

Universität Erlangen-Nürnberg; 🇩🇪 Erlangen, Germany

Georg-August-Universität Göttingen; 🇩🇪 Göttingen, Germany

Krankenhaus Dresden Friedrichstadt; 🇩🇪 Dresden, Germany

Universitätsklinikum Jena; 🇩🇪 Jena, Germany

Universitätsklinikum Kiel; 🇩🇪 Kiel, Germany

HELIOS Klinikum Erfurt; 🇩🇪 Erfurt, Germany

Martin-Luther-Universität Halle/Wittenberg; 🇩🇪 Halle/Saale, Germany

Universitätsklinikum der RWTH Aachen; 🇩🇪 Aachen, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

Universitätsklinikum Leipzig; 🇩🇪 Leipzig, Germany

Klinikum Augsburg; 🇩🇪 Augsburg, Germany

Städtisches Klinikum Brandenburg GmbH; 🇩🇪 Brandenburg, Germany

VIVANTES Klinikum Neukölln II; 🇩🇪 Berlin, Germany

Universität Carl-Gustav-Carus; 🇩🇪 Dresden, Germany

Ernst-Moritz-Arndt-Universität; 🇩🇪 Greifswald, Germany