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
2 other identifiers
interventional
231
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 sepsis
Started May 2005
Longer than P75 for phase_4 sepsis
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 6, 2006
CompletedFirst Posted
Study publicly available on registry
January 9, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedAugust 12, 2011
August 1, 2011
5.1 years
January 6, 2006
August 11, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (2)
Kidney function
at intensive care discharge and after one year
Lung function
during intensive care
Study Arms (1)
HES, Septic shock, resuscitation
ACTIVE COMPARATORstudy group with HES 6%
Interventions
hydroxy-ethyl starch together with ringer's lactate versus physiologic saline together with saline
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnancy
- Age below 18
- Allergy against Hydroxyethyl starch
- Chronic renal insufficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Basel, Switzerlandlead
- Fresenius AGcollaborator
Study Sites (2)
Surgical ICU, University Hospital Basel
Basel, 4031, Switzerland
Medical ICU, Univesity Hospital Basel
Basel, CH-4031, Switzerland
Related Publications (6)
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.
PMID: 11794169BACKGROUNDVincent 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.
PMID: 15542955BACKGROUNDFinfer 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.
PMID: 15163774BACKGROUNDSchortgen 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.
PMID: 11289347BACKGROUNDDe 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.
PMID: 12091178BACKGROUNDDellinger 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.
PMID: 12627010BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Siegemund, MD
Anaesthesia and Intensive Care, State Hospital, CH-5404 Baden, Switzerland
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 6, 2006
First Posted
January 9, 2006
Study Start
May 1, 2005
Primary Completion
June 1, 2010
Study Completion
May 1, 2011
Last Updated
August 12, 2011
Record last verified: 2011-08