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

SepNet - Critical Care Trials Group

Status and phase

Completed

Phase 3

Conditions

Severe Sepsis

Septic Shock

Treatments

Drug: Actrapid® (Insulin)

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

Drug: Sterofundin® (Ringer lactate solution)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00135473

01 KI 0106 (BMBF)

SEPNET-200304

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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