NCT00135473

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2003

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2005

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

February 11, 2016

Status Verified

February 1, 2016

First QC Date

August 24, 2005

Last Update Submit

February 10, 2016

Conditions

Severe SepsisSeptic Shock

Keywords

Severe sepsisseptic shockvolume substitutionintensive insulin therapycolloidscrystalloidsoutcomesafety

Outcome Measures

Primary Outcomes (2)

  • Mortality (28 day)

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

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Age \< 18 years
  • Pregnancy
  • Known allergy against hydroxyethyl starch
  • Pre-existing kidney failure requiring dialysis or serum creatinine value \> 320 mmol/l (3,6 mg/dl)
  • Intracerebral hemorrhage
  • Severe head trauma with edema
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Universitätsklinikum der RWTH Aachen

Aachen, 52074, Germany

Location

Klinikum Augsburg

Augsburg, 86156, Germany

Location

VIVANTES Klinikum Neukölln II

Berlin, 12313, Germany

Location

Charité I Campus Virchow-Klinikum

Berlin, 13353, Germany

Location

Städtisches Klinikum Brandenburg GmbH

Brandenburg, 14770, Germany

Location

Krankenhaus Dresden Friedrichstadt

Dresden, 01067, Germany

Location

Universität Carl-Gustav-Carus

Dresden, 01067, Germany

Location

HELIOS Klinikum Erfurt

Erfurt, 99089, Germany

Location

Universität Erlangen-Nürnberg

Erlangen, 91054, Germany

Location

Georg-August-Universität Göttingen

Göttingen, 37075, Germany

Location

Ernst-Moritz-Arndt-Universität

Greifswald, 17487, Germany

Location

Martin-Luther-Universität Halle/Wittenberg

Halle, 06097, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Universitätsklinikum Jena

Jena, 07743, Germany

Location

Universitätsklinikum Kiel

Kiel, 24105, Germany

Location

Universitätsklinikum Leipzig

Leipzig, 04103, Germany

Location

Related Publications (1)

  • 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.

    PMID: 18184958DERIVED

MeSH Terms

Conditions

SepsisShock, Septic

Interventions

Hydroxyethyl Starch DerivativessterofundinInsulin

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

StarchDietary CarbohydratesCarbohydratesGlucansPolysaccharidesProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Konrad Reinhart, MD

    F.-Schiller-University Jena, Germany

    STUDY CHAIR

  • Thomas Deufel, MD

    F.-Schiller-University Jena, Germany

    STUDY DIRECTOR

  • Markus Löffler, MD

    University of Leipzig

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 24, 2005

First Posted

August 26, 2005

Study Start

April 1, 2003

Study Completion

September 1, 2005

Last Updated

February 11, 2016

Record last verified: 2016-02

Locations

DE(16)