BaSES Trial: Basel Starch Evaluation in Sepsis - Full Text View

Sponsors and Collaborators:	University Hospital, Basel, Switzerland Fresenius AG
Information provided by:	University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:	NCT00273728

Purpose

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

Condition	Intervention	Phase
Sepsis Severe Sepsis Septic Shock	Drug: hydroxy-ethyl starch (MW 130; 0.4) vs. normal saline	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Basel Study for Evaluation of Starch (130;0.4) Infusion in Septic Patients: BaSES (130;0.4) Trial

Resource links provided by NLM:

MedlinePlus related topics: Sepsis

Drug Information available for: Starch Hetastarch

U.S. FDA Resources

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:

Intensive Care length of stay
Hospital length of stay
Mortality

Secondary Outcome Measures:

Kidney function
Lung function

Estimated Enrollment:	250
Study Start Date:	May 2005
Estimated Study Completion Date:	December 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00273728

Contacts

Contact: Martin Siegemund, MD

+41 61 3286505

siegemundm@uhbs.ch

Locations

Switzerland
Medical ICU, Univesity Hospital Basel	Recruiting
Basel, Switzerland, CH-4031
Contact: Martin Siegemund, MD +41 61 3186505 siegemundm@uhbs.ch
Sub-Investigator: Stephan UC Marsch, MD, PhD
Surgical ICU, University Hospital Basel	Recruiting
Basel, Switzerland, 4031
Contact: Martin Siegemund, MD +41 61 32 86505 siegemundm@uhbs.ch
Contact: Hans Pargger, MD parggerh@uhbs.ch
Sub-Investigator: Hans Pargger, MD

Sponsors and Collaborators

University Hospital, Basel, Switzerland

Fresenius AG

Investigators

Principal Investigator:

Martin Siegemund, MD

Intensive Care Unit, University Hospital Basel, CH-4031 Basel, Switzerland

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

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.

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. Review.

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.

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.

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.

Dellinger RP. Cardiovascular management of septic shock. Crit Care Med. 2003 Mar;31(3):946-55. Review. No abstract available.

Study ID Numbers:	Swissmedic: 2005DR3123, EKBB: EK 244/04
Study First Received:	January 6, 2006
Last Updated:	October 31, 2006
ClinicalTrials.gov Identifier:	NCT00273728 History of Changes
Health Authority:	Swiss Agency for Therapeutic Products: Switzerland; Swiss Federal Office of Public Health: Switzerland

Keywords provided by University Hospital, Basel, Switzerland:

Hydroxyethyl Starch
shock, septic
infusion, intravenous
mortality

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Sepsis
Shock
Shock, Septic

Hetastarch
Plasma Substitutes
Inflammation

Additional relevant MeSH terms:

Systemic Inflammatory Response Syndrome
Hematologic Agents
Hetastarch
Infection
Pharmacologic Actions
Inflammation
Sepsis

Pathologic Processes
Shock
Therapeutic Uses
Shock, Septic
Blood Substitutes
Plasma Substitutes

ClinicalTrials.gov processed this record on September 01, 2009