BaSES Trial: Basel Starch Evaluation in Sepsis (BaSES)

Basel Study for Evaluation of Starch (130;0.4) Infusion in Septic Patients: BaSES (130;0.4) Trial

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

Study Overview

• Status: Completed
• Conditions: Sepsis; Septic Shock; Severe Sepsis
• Intervention / Treatment: Drug: hydroxy-ethyl starch (MW 130; 0.4) vs. normal saline

• Study Type: Interventional
• Enrollment (Actual): 231
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Surgical ICU, University Hospital Basel
  • Basel, Switzerland, CH-4031
    • Medical ICU, Univesity Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: HES, Septic shock, resuscitation; study group with HES 6%	Drug: hydroxy-ethyl starch (MW 130; 0.4) vs. normal saline; hydroxy-ethyl starch together with ringer's lactate versus physiologic saline together with saline; Other Names: NaCl 0.9%; Voluven; Ringer's lactate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Intensive Care length of stay	time to discharge from the Intensive care unit
Hospital length of stay	time to discharge from the hospital
Mortality	intesive care, hospital and one year mortality

Secondary Outcome Measures

Outcome Measure	Time Frame
Kidney function	at intensive care discharge and after one year
Lung function	during intensive care

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: Fresenius AG
• Investigators: Principal Investigator: Martin Siegemund, MD, Anaesthesia and Intensive Care, State Hospital, CH-5404 Baden, Switzerland

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• Link to the homepage of the Department of Anaesthesia and Intensive Care Basel, Switzerland

Study record dates

Study Major Dates

• Study Start: May 1, 2005
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: January 6, 2006
• First Submitted That Met QC Criteria: January 6, 2006
• First Posted (Estimate): January 9, 2006

Study Record Updates

• Last Update Posted (Estimate): August 12, 2011
• Last Update Submitted That Met QC Criteria: August 11, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: mortality; shock, septic; Hydroxyethyl Starch; infusion, intravenous
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: Swissmedic: 2005DR3123; EKBB: EK 244/04