Clinical trial NCT00273728: BaSES Trial: Basel Starch Evaluation in Sepsis
Official title: Basel Study for Evaluation of Starch (130;0.4) Infusion in Septic Patients: BaSES (130;0.4) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sepsis
Severe Sepsis
Septic Shock
Keywords: Hydroxyethyl Starch
shock, septic
infusion, intravenous
mortality
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Fresenius AG
First posted: 2006-01-09
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: In patients with severe sepsis and septic shock early aggressive volume replacement reduced mortality. Standard infusion therapy consists of crystalloid infusions. The role of modern, low molecular weight, starch preparations and their influence on the course of disease is not determined yet.

Hypothesis: The purpose of this study is to determine wether initial infusion therapy with Hydroxyethylstarch and Ringer's lactate reduces in septic patients reduces Intensive Care Unit and hospital length of stay without impairment of renal function

Design: Double-blind, randomized, controlled monocentric study

Setting: Intensive Care Units of a University Hospital

Patients: 240 consecutive patients with sepsis, severe sepsis and septic shock

Intervention: Volume therapy with Ringer's lactate and saline or hydroxy-ethyl starch (MW 130, substitution 0.4) in the first five days of intensive care treatment.

Parameter:

* Intensive Care length of stay
* Hospital length of stay
* Mortality
* Kidney function

Statistics: Mann-Whitney test for non-parametric data like intensive care length of stay. Unpaired t-Test for kidney function parameters.

Study withdrawal: Significant impairment of kidney function parameters in the hydroxy-ethyl starch group


Eligibility criteria: Inclusion Criteria:

* Patients with suspected or proven infection and 2 of the following 6 criteria:
* Body temperature \<36 or \>38.3° celsius
* Heart rate \> 90 beats/min
* Tachypnea \> 20/min or a arterial pCO2 below 4.25 kPa
* White blood cell count higher than 12.000 or below 4.000 or more than 10% immature forms
* Systolic blood pressure \<90 mmHg or mean arterial pressure \< 65 mmHg
* Altered mental state or oliguria

Exclusion Criteria:

* Pregnancy
* Age below 18
* Allergy against Hydroxyethyl starch
* Chronic renal insufficiency

Primary outcomes:
measure: Intensive Care length of stay
timeFrame: time to discharge from the Intensive care unit
measure: Hospital length of stay
timeFrame: time to discharge from the hospital
measure: Mortality
timeFrame: intesive care, hospital and one year mortality
Secondary outcomes:
measure: Kidney function
timeFrame: at intensive care discharge and after one year
measure: Lung function
timeFrame: during intensive care
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Surgical ICU, University Hospital Basel
city: Basel
country: Switzerland
facility: Medical ICU, Univesity Hospital Basel
Study officials:
affiliation: Anaesthesia and Intensive Care, State Hospital, CH-5404 Baden, Switzerland
name: Martin Siegemund, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307.
citation: Vincent JL, Gerlach H. Fluid resuscitation in severe sepsis and septic shock: an evidence-based review. Crit Care Med. 2004 Nov;32(11 Suppl):S451-4. doi: 10.1097/01.ccm.0000142984.44321.a4.
citation: Finfer S, Bellomo R, Boyce N, French J, Myburgh J, Norton R; SAFE Study Investigators. A comparison of albumin and saline for fluid resuscitation in the intensive care unit. N Engl J Med. 2004 May 27;350(22):2247-56. doi: 10.1056/NEJMoa040232.
citation: Schortgen F, Lacherade JC, Bruneel F, Cattaneo I, Hemery F, Lemaire F, Brochard L. Effects of hydroxyethylstarch and gelatin on renal function in severe sepsis: a multicentre randomised study. Lancet. 2001 Mar 24;357(9260):911-6. doi: 10.1016/S0140-6736(00)04211-2.
citation: De Backer D, Creteur J, Preiser JC, Dubois MJ, Vincent JL. Microvascular blood flow is altered in patients with sepsis. Am J Respir Crit Care Med. 2002 Jul 1;166(1):98-104. doi: 10.1164/rccm.200109-016oc.
citation: Dellinger RP. Cardiovascular management of septic shock. Crit Care Med. 2003 Mar;31(3):946-55. doi: 10.1097/01.CCM.0000057403.73299.A6. No abstract available.