NCT00135473

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (planned)
• Sponsor: SepNet - Critical Care Trials Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2003-04-01
• Completion: 2005-09-01
• First posted: 2005-08-26
• Last updated: 2016-02-11

Locations

16 sites across 1 country: Germany