BaSES Trial: Basel Starch Evaluation in Sepsis

Sepsis Clinical Trial

— BaSES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00273728
• Other study ID #: Swissmedic: 2005DR3123
• Secondary ID: EKBB: EK 244/04
• Status: Completed
• Phase: Phase 4
• First received: January 6, 2006
• Last updated: August 11, 2011
• Start date: May 2005
• Est. completion date: May 2011

Study information

• Verified date: August 2011
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: SwissmedicSwitzerland: Federal Office of Public Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: May 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sepsis
• Septic Shock
• Severe Sepsis
• Toxemia

Intervention

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

Locations

Country	Name	City	State
Switzerland	Medical ICU, Univesity Hospital Basel	Basel
Switzerland	Surgical ICU, University Hospital Basel	Basel

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Fresenius AG

Country where clinical trial is conducted

Switzerland, 

References & Publications (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. — View Citation

Dellinger RP. Cardiovascular management of septic shock. Crit Care Med. 2003 Mar;31(3):946-55. Review. — View 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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensive Care length of stay		time to discharge from the Intensive care unit	No
Primary	Hospital length of stay		time to discharge from the hospital	No
Primary	Mortality		intesive care, hospital and one year mortality	No
Secondary	Kidney function		at intensive care discharge and after one year	Yes
Secondary	Lung function		during intensive care	No

External Links

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