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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00135473

Enrollment

600

Registered

2005-08-26

Start date

2003-04-30

Completion date

2005-09-30

Last updated

2016-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock, Severe Sepsis

Keywords

Severe sepsis, septic shock, volume substitution, intensive insulin therapy, colloids, crystalloids, outcome, safety

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.

Interventions

DRUG10% Hemohes® (10% Hydroxyethyl starch)

DRUGSterofundin® (Ringer lactate solution)

DRUGActrapid® (Insulin)

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Frequency of therapy with vasopressors (in days)	—
Course of SOFA sub-scores	—
Frequency of hemorrhages under hydroxyethyl starch (HES) therapy	—
Frequency of acute kidney failure	—
Frequency of critical illness polyneuropathy (CIP)	—
90 day Mortality	—
Frequency of hypoglycemia under intensive insulin therapy	—
Time until hemodynamic stabilization	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026