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

NCT ID: NCT00135473

Last Updated: 2016-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-04-30
• Study Completion Date: 2005-09-30

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.

Conditions

Severe Sepsis; Septic Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

10% Hemohes® (10% Hydroxyethyl starch)

Intervention Type: DRUG

Sterofundin® (Ringer lactate solution)

Intervention Type: DRUG

Actrapid® (Insulin)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role: collaborator

B. Braun Melsungen AG

INDUSTRY

Sponsor Role: collaborator

Novo Nordisk A/S

INDUSTRY

Sponsor Role: collaborator

HemoCue

INDUSTRY

Sponsor Role: collaborator

SepNet - Critical Care Trials Group

OTHER

Sponsor Role: lead

Principal Investigators

Konrad Reinhart, MD

Role: STUDY_CHAIR

F.-Schiller-University Jena, Germany

Thomas Deufel, MD

Role: STUDY_DIRECTOR

F.-Schiller-University Jena, Germany

Markus Löffler, MD

Role: STUDY_DIRECTOR

University of Leipzig

Locations

Universitätsklinikum der RWTH Aachen

Aachen, , Germany

Klinikum Augsburg

Augsburg, , Germany

VIVANTES Klinikum Neukölln II

Berlin, , Germany

Charité I Campus Virchow-Klinikum

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, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

Universitätsklinikum Jena

Jena, , Germany

Universitätsklinikum Kiel

Kiel, , Germany

Universitätsklinikum Leipzig

Leipzig, , Germany

Countries

Germany

References

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. doi: 10.1056/NEJMoa070716.

Reference Type: DERIVED

PMID: 18184958 (View on PubMed)

Other Identifiers

01 KI 0106 (BMBF)

Identifier Type: -

Identifier Source: secondary_id

SEPNET-200304

Identifier Type: -

Identifier Source: org_study_id