Severe SepsisPhase 3NCT00135473
Efficacy of Volume Substitution and Insulin Therapy in Severe Sepsis (VISEP Trial)
A Phase 3 study testing 10% Hemohes® (10% Hydroxyethyl starch), Sterofundin® (Ringer lactate solution) and Actrapid® (Insulin) in people with Severe Sepsis and Septic Shock, run by SepNet - Critical Care Trials Group at 16 sites in Germany.
Trial summary
The purpose of this trial is to determine the influence of colloid versus crystalloid volume resuscitation and of intensive vs conventional insulin therapy on morbidity and mortality of patients with severe sepsis and septic shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Sepsis, Septic Shock
- What is being tested?
- 10% Hemohes® (10% Hydroxyethyl starch), Sterofundin® (Ringer lactate solution) and Actrapid® (Insulin)
- How many people
- 600 participants
- Where
- 16 sitesGermany
- Study dates
- Apr 2003to Sep 2005
- Phase
- Phase 3
- 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 fulfilling the criteria of "severe sepsis" or "septic shock" according to the Society of Critical Care Medicine/American College of Chest Physicians (SCCM/ACCP) definitions not longer than 24 hours before ICU admission or 12 hours after ICU admission
Who cannot join
- Age < 18 years
- Pregnancy
- Known allergy against hydroxyethyl starch
- Pre-treatment with > 1000ml hydroxyethyl starch within 24 hours before inclusion
- Pre-existing kidney failure requiring dialysis or serum creatinine value > 320 mmol/l (3,6 mg/dl)
- Intracerebral hemorrhage
Show all 12Show fewer
- Severe head trauma with edema
- FiO2 at time of study inclusion > 0,7
- Heart failure (New York Heart Association [NYHA] IV)
- Enrolment in another interventional study
- Immune suppression (cytostatic chemotherapy, steroid therapy, AIDS)
- Do not resuscitate (DNR) order
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Germany16 sites
Universitätsklinikum der RWTH Aachen
Aachen, 52074
Klinikum Augsburg
Augsburg, 86156
VIVANTES Klinikum Neukölln II
Berlin, 12313
Charité I Campus Virchow-Klinikum
Berlin, 13353
Städtisches Klinikum Brandenburg GmbH
Brandenburg, 14770
Krankenhaus Dresden Friedrichstadt
Dresden, 01067
Universität Carl-Gustav-Carus
Dresden, 01067
HELIOS Klinikum Erfurt
Erfurt, 99089
Universität Erlangen-Nürnberg
Erlangen, 91054
Georg-August-Universität Göttingen
Göttingen, 37075
Ernst-Moritz-Arndt-Universität
Greifswald, 17487
Martin-Luther-Universität Halle/Wittenberg
Halle, 06097
Medizinische Hochschule Hannover
Hanover, 30625
Universitätsklinikum Jena
Jena, 07743
Universitätsklinikum Kiel
Kiel, 24105
Universitätsklinikum Leipzig
Leipzig, 04103
About this study
Official title: Prospective Randomized Multicenter Study on the Influence of Colloid vs Crystalloid Volume Resuscitation and of Intensive vs Conventional Insulin Therapy on Outcome in Patients With Severe Sepsis and Septic Shock
The purpose of this trial is to determine the influence of colloid versus crystalloid volume resuscitation and of intensive vs conventional insulin therapy on morbidity and mortality of patients with severe sepsis and septic shock.
Read the detailed description
Severe sepsis and septic shock have a high mortality. Research has concentrated on adjunctive sepsis therapies; the role of supportive measures is comparatively unclear. In Europe the use of colloids is widespread, but there is no evidence on the role of either crystalloid or colloid volume therapy in sepsis. Recently, a higher incidence of kidney failure in sepsis was reported after administration of colloids.
In critical illness, a significant reduction in mortality was recently achieved by strict glycemic control, however it has to be determined whether this is true and safe for patients with sepsis as well.
- Conditions
- Severe Sepsis, Septic Shock
- Being tested
- 10% Hemohes® (10% Hydroxyethyl starch), Sterofundin® (Ringer lactate solution), Actrapid® (Insulin)
- Keywords
- Severe sepsis, septic shock, volume substitution, intensive insulin therapy, colloids, crystalloids, outcome, safety
- 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.
10% Hemohes® (10% Hydroxyethyl starch)Drug
Sterofundin® (Ringer lactate solution)Drug
Actrapid® (Insulin)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality (28 day)
Morbidity (mean sepsis-related organ failure assessment [SOFA] score during intensive care unit length of stay [ICU LOS])
Secondary outcomes (8)
Frequency of acute kidney failure
Time until hemodynamic stabilization
Frequency of therapy with vasopressors (in days)
Course of SOFA sub-scores
Frequency of hemorrhages under hydroxyethyl starch (HES) therapy
Frequency of hypoglycemia under intensive insulin therapy
Frequency of critical illness polyneuropathy (CIP)
90 day Mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2005 (estimated)
- Study startApr 2003
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- SepNet - Critical Care Trials Group
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, B. Braun Melsungen AG, Novo Nordisk A/S, HemoCue
- Investigators
- Konrad Reinhart, MD, Study chair, F.-Schiller-University Jena, GermanyThomas Deufel, MD, Study director, F.-Schiller-University Jena, GermanyMarkus Löffler, MD, Study director, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00135473
- Sponsor's protocol ID
- SEPNET-200304
- Other IDs
- 01 KI 0106 (BMBF)
- Status last verified
- Feb 2016
- First submitted
- 24 Aug 2005
- Last updated
- 11 Feb 2016
- Results posted
- No
Publications
Brunkhorst FM, Engel C, Bloos F, Meier-Hellmann A, Ragaller M, Weiler N, Moerer O, Gruendling M, Oppert M, Grond S, Olthoff D, Jaschinski U, John S, Rossaint R, Welte T, Schaefer M, Kern P, Kuhnt E, Kiehntopf M, Hartog C, Natanson C, Loeffler M, Reinhart K; German Competence Network Sepsis (SepNet). Intensive insulin therapy and pentastarch resuscitation in severe sepsis. N Engl J Med. 2008 Jan 10;358(2):125-39. doi: 10.1056/NEJMoa070716.
PubMed 18184958
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Multicenter Study on the Influence of Colloid vs Crystalloid Volume Resuscitation and of Intensive vs Conventional Insulin Therapy on Outcome in Patients With Severe Sepsis and Septic Shock
- ClinicalTrials.gov ID
- NCT00135473
- Acronym / sponsor ID
- SEPNET-200304
- Conditions
- Severe Sepsis, Septic Shock
- Keywords
- Severe sepsis, septic shock, volume substitution, intensive insulin therapy, colloids, crystalloids, outcome, safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants
- Lead sponsor
- SepNet - Critical Care Trials GroupUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, B. Braun Melsungen AG, Novo Nordisk A/S, HemoCue
- Study start
- Apr 2003
- Study completion
- Sep 2005
- First posted
- 26 Aug 2005 (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.
The purpose of this trial is to determine the influence of colloid versus crystalloid volume resuscitation and of intensive vs conventional insulin therapy on morbidity and mortality of patients with severe sepsis and septic shock.
Detailed description
Severe sepsis and septic shock have a high mortality. Research has concentrated on adjunctive sepsis therapies; the role of supportive measures is comparatively unclear. In Europe the use of colloids is widespread, but there is no evidence on the role of either crystalloid or colloid volume therapy in sepsis. Recently, a higher incidence of kidney failure in sepsis was reported after administration of colloids.
In critical illness, a significant reduction in mortality was recently achieved by strict glycemic control, however it has to be determined whether this is true and safe for patients with sepsis as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients fulfilling the criteria of "severe sepsis" or "septic shock" according to the Society of Critical Care Medicine/American College of Chest Physicians (SCCM/ACCP) definitions not longer than 24 hours before ICU admission or 12 hours after ICU admission
Key exclusion criteria (12 listed)
- Age < 18 years
- Pregnancy
- Known allergy against hydroxyethyl starch
- Pre-treatment with > 1000ml hydroxyethyl starch within 24 hours before inclusion
- Pre-existing kidney failure requiring dialysis or serum creatinine value > 320 mmol/l (3,6 mg/dl)
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 |
|---|---|---|
| 10% Hemohes® (10% Hydroxyethyl starch) | Drug | – |
| Sterofundin® (Ringer lactate solution) | Drug | – |
| Actrapid® (Insulin) | Drug | – |
Primary outcome
Mortality (28 day)
Morbidity (mean sepsis-related organ failure assessment [SOFA] score during intensive care unit length of stay [ICU LOS])
8 secondary outcomes
Frequency of acute kidney failure
Time until hemodynamic stabilization
Frequency of therapy with vasopressors (in days)
Course of SOFA sub-scores
Frequency of hemorrhages under hydroxyethyl starch (HES) therapy
Frequency of hypoglycemia under intensive insulin therapy
Frequency of critical illness polyneuropathy (CIP)
90 day Mortality
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 11 Feb 2016.
- Derived from this study: PubMed 18184958Brunkhorst FM, Engel C, Bloos F, Meier-Hellmann A, Ragaller M, Weiler N, Moerer O, Gruendling M, Oppert M, Grond S, Olthoff D, Jaschinski U, John S, Rossaint R, Welte T, Schaefer M, Kern P, Kuhnt E, Kiehntopf M, Hartog C, Natanson C, Loeffler M, Reinhart K; German Competence Network Sepsis (SepNet). Intensive insulin therapy and pentastarch resuscitation in severe sepsis. N Engl J Med. 2008 Jan 10;358(2):125-39. doi: 10.1056/NEJMoa070716.
Related trials for Severe Sepsis
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
Not yet recruitingObservational study
Blood Pressure Goal in Preterm Preeclampsia
Hypertensive Disorder of Pregnancy, Preeclampsia
Not yet recruitingEarly Phase 1
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
EBV Viremia, CMV Viremia
Recruiting
Efficacy and Safety of Methylene Blue in the Treatment of Severe Septic Shock
Septic Shock, Methylene Blue
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.
Konrad Reinhart, MD study chair
F.-Schiller-University Jena, Germany
Thomas Deufel, MD study director
F.-Schiller-University Jena, Germany
Markus Löffler, MD study director
University of Leipzig
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 10% Hemohes® (10% Hydroxyethyl starch), Sterofundin® (Ringer lactate solution) and Actrapid® (Insulin) in people with Severe Sepsis and Septic Shock, run by SepNet - Critical Care Trials Group at 16 sites in Germany.
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 1 inclusion and 12 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 11 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Mortality (28 day). The study lists 2 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 NCT00135473, which also lists 1 linked publication.
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 11 Feb 2016.