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BaSES Trial: Basel Starch Evaluation in Sepsis (BaSES)

Primary Purpose

Sepsis, Severe Sepsis, Septic Shock

Status

Completed

Phase

Phase 4

Locations

Switzerland

Study Type

Interventional

Intervention

hydroxy-ethyl starch (MW 130; 0.4) vs. normal saline

About this trial

This is an interventional treatment trial for Sepsis focused on measuring Hydroxyethyl Starch, shock, septic, infusion, intravenous, mortality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Surgical ICU, University Hospital Basel
Medical ICU, Univesity Hospital Basel

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

HES, Septic shock, resuscitation

Arm Description

study group with HES 6%

Outcomes

Primary Outcome Measures

Intensive Care length of stay

Hospital length of stay

Mortality

Secondary Outcome Measures

Kidney function

Lung function

Full Information

NCT ID

NCT00273728

First Posted

January 6, 2006

Last Updated

August 11, 2011

Sponsor

University Hospital, Basel, Switzerland

Collaborators

Fresenius AG

1. Study Identification

Unique Protocol Identification Number

NCT00273728

Brief Title

BaSES Trial: Basel Starch Evaluation in Sepsis

Acronym

BaSES

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Completed

Study Start Date

May 2005 (undefined)

Primary Completion Date

June 2010 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Basel, Switzerland

Collaborators

Fresenius AG

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sepsis, Severe Sepsis, Septic Shock

Keywords

Hydroxyethyl Starch, shock, septic, infusion, intravenous, mortality

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

231 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HES, Septic shock, resuscitation

Arm Type

Active Comparator

Arm Description

study group with HES 6%

Intervention Type

Drug

Intervention Name(s)

hydroxy-ethyl starch (MW 130; 0.4) vs. normal saline

Other Intervention Name(s)

Voluven, Ringer's lactate, NaCl 0.9%

Intervention Description

hydroxy-ethyl starch together with ringer's lactate versus physiologic saline together with saline

Primary Outcome Measure Information:

Title

Intensive Care length of stay

Time Frame

time to discharge from the Intensive care unit

Title

Hospital length of stay

Time Frame

time to discharge from the hospital

Title

Mortality

Time Frame

intesive care, hospital and one year mortality

Secondary Outcome Measure Information:

Title

Kidney function

Time Frame

at intensive care discharge and after one year

Title

Lung function

Time Frame

during intensive care

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martin Siegemund, MD

Organizational Affiliation

Anaesthesia and Intensive Care, State Hospital, CH-5404 Baden, Switzerland

Official's Role

Principal Investigator

Facility Information:

Facility Name

Surgical ICU, University Hospital Basel

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

Facility Name

Medical ICU, Univesity Hospital Basel

City

Basel

ZIP/Postal Code

CH-4031

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

11794169

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.

Results Reference

background

PubMed Identifier

15542955

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.

Results Reference

background

PubMed Identifier

15163774

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.

Results Reference

background

PubMed Identifier

11289347

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.

Results Reference

background

PubMed Identifier

12091178

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.

Results Reference

background

PubMed Identifier

12627010

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.

Results Reference

background

Links:

URL

http://www.medana.unibas.ch/

Description

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

Learn more about this trial

BaSES Trial: Basel Starch Evaluation in Sepsis

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