SepsisPhase 4BaSESNCT00273728
BaSES Trial: Basel Starch Evaluation in Sepsis
A Phase 4 study testing hydroxy-ethyl starch (MW 130; 0.4) vs. normal saline in people with Sepsis and Severe Sepsis, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Severe Sepsis, Septic Shock
- What is being tested?
- hydroxy-ethyl starch (MW 130; 0.4) vs. normal saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 231 participants
- Where
- 2 sitesSwitzerland
- Study dates
- May 2005to May 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Age below 18
- Allergy against Hydroxyethyl starch
- Chronic renal insufficiency
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Surgical ICU, University Hospital Basel
Basel, 4031
Medical ICU, Univesity Hospital Basel
Basel, CH-4031
About this study
Official title: 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
Read more
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
- Conditions
- Sepsis, Severe Sepsis, Septic Shock
- Being tested
- hydroxy-ethyl starch (MW 130; 0.4) vs. normal saline
- Keywords
- Hydroxyethyl Starch, shock, septic, infusion, intravenous, mortality
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydroxy-ethyl starch (MW 130; 0.4) vs. normal salineDrug
Also called Voluven, Ringer's lactate, NaCl 0.9%
hydroxy-ethyl starch together with ringer's lactate versus physiologic saline together with saline
| Study group | Role | What they receive |
|---|---|---|
| HES, Septic shock, resuscitation | Active comparator | study group with HES 6% Receives: Drug: hydroxy-ethyl starch (MW 130; 0.4) vs. normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensive Care length of stay
Measured: time to discharge from the Intensive care unit
Hospital length of stay
Measured: time to discharge from the hospital
Mortality
Measured: intesive care, hospital and one year mortality
Secondary outcomes (2)
Kidney function
Measured: at intensive care discharge and after one year
Lung function
Measured: during intensive care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2006 (estimated)
- Study startMay 2005
- Primary completionJun 2010
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Fresenius AG
- Investigators
- Martin Siegemund, MD, Principal investigator, Anaesthesia and Intensive Care, State Hospital, CH-5404 Baden, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00273728
- Sponsor's protocol ID
- Swissmedic: 2005DR3123
- Other IDs
- EKBB: EK 244/04
- Acronym
- BaSES
- Status last verified
- Aug 2011
- First submitted
- 6 Jan 2006
- Last updated
- 12 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 11794169Vincent 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.
PubMed 15542955Finfer 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.
PubMed 15163774Schortgen 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.
PubMed 11289347De 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.
PubMed 12091178Dellinger 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.
PubMed 12627010
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Basel Study for Evaluation of Starch (130;0.4) Infusion in Septic Patients: BaSES (130;0.4) Trial
- ClinicalTrials.gov ID
- NCT00273728
- Acronym / sponsor ID
- BaSES / Swissmedic: 2005DR3123
- Conditions
- Sepsis, Severe Sepsis, Septic Shock
- Keywords
- Hydroxyethyl Starch, shock, septic, infusion, intravenous, mortality
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Fresenius AG
- Study start
- May 2005
- Primary completion
- Jun 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 9 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HES, Septic shock, resuscitation | Active comparator | Drug: hydroxy-ethyl starch (MW 130; 0.4) vs. normal salinestudy group with HES 6% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnancy
- Age below 18
- Allergy against Hydroxyethyl starch
- Chronic renal insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hydroxy-ethyl starch (MW 130; 0.4) vs. normal salineAlso: Voluven, Ringer's lactate, NaCl 0.9%hydroxy-ethyl starch together with ringer's lactate versus physiologic saline together with saline | Drug | HES, Septic shock, resuscitation |
Primary outcome
Intensive Care length of stay
Time frame: time to discharge from the Intensive care unit
Hospital length of stay
Time frame: time to discharge from the hospital
Mortality
Time frame: intesive care, hospital and one year mortality
2 secondary outcomes
Kidney function
Time frame: at intensive care discharge and after one year
Lung function
Time frame: during intensive care
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2011.
- Background: PubMed 11794169Rivers 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.
- Background: PubMed 15542955Vincent 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.
- Background: PubMed 15163774Finfer 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.
- Background: PubMed 11289347Schortgen 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.
- Background: PubMed 12091178De 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.
- Background: PubMed 12627010Dellinger 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.
- Link to the homepage of the Department of Anaesthesia and Intensive Care Basel, SwitzerlandLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Siegemund, MD principal investigator
Anaesthesia and Intensive Care, State Hospital, CH-5404 Baden, Switzerland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing hydroxy-ethyl starch (MW 130; 0.4) vs. normal saline in people with Sepsis and Severe Sepsis, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensive Care length of stay (time frame: time to discharge from the Intensive care unit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00273728, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2011.