Septic ShockASSETNCT02335723
ASSET - a Double-Blind, Randomized Placebo-Controlled Clinical Investigation With Alteco® LPS Adsorber
A study testing Alteco LPS Adsorber in people with Septic Shock, run by Alteco Medical AB at 6 sites in 3 countries.
Trial summary
The primary objective of this clinical investigation is to investigate the feasibility and possible benefits of the Alteco® LPS Adsorber in treating patients with septic shock with presumed endotoxemia of abdominal or urogenital origin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Alteco LPS Adsorber
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Sep 2015to 28 Apr 2017
- Phase
- Interventional
- 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
- Illness severity criteria: At enrolment subjects must meet inclusion criteria #1 through #3 listed below to be eligible to enter the clinical investigation:
- Subjects must have suspected severe infection of abdominal or urogenital origin for which the subject is receiving intravenous antimicrobial therapy as the main reason for organ support
- Subjects, males or females, must be 18 years or older.
- Subjects or legally acceptable representatives, as appropriate, are willing and able to provide signed informed consent.
- Treatment criteria: Prior to randomization, subjects must meet all inclusion criteria (#4 through #7) listed below to be assigned to a treatment group:
- Appropriate vascular access must have been obtained.
Show all 9Show fewer
- Subjects must have received ≥ 30 mL/kg of intravenous fluid within the six (6) hours prior to randomization.
- Subjects must have plasma/serum lactate >2 mmol/L despite adequate resuscitation AND a continuous requirement for vasopressor support
- Subjects must be able to initiate the clinical investigation intervention within 12 hours of fulfilment of the illness severity criteria.
Who cannot join
- Subjects who meet any of the exclusion criteria listed below will NOT be permitted to enter the clinical investigation: Sepsis-induced organ dysfunction for longer than 12 hours prior to the time-point for achieving "Illness severity criteria fulfilled"
- Vasopressor therapy (at any dose) for longer than 12 hours (not included the time spent in the operation theatre) prior to the start of treatment with the investigational device.
- Pre-existing uncorrectable medical condition as:
- Poorly controlled neoplasms or hematologic disease (i.e. indication of disseminated cancer outside the suspected primary tumour and hematologic disease not in remission,
- End-stage cardiac disease,
- Cardiac arrest requiring cardiopulmonary resuscitation or with pulseless electrical activity or asystole within the past 7 days
Show all 20Show fewer
- End-stage lung disease
- End-stage liver disease
- HIV/AIDS with known end-stage processes
- Other uncorrectable medical condition(s) deemed by the Clinical Investigator to hinder the subject to adhere to the fulfilment of the activities described in the Clinical Investigation Plan.
- Extreme illness, i.e. subjects is moribund and death is perceived to be imminent (within 24 hours).
- Recent or current participation (≤ 30 days) in another interventional sepsis trial.
- Recent or current treatment (≤ 30 days) with an adsorption product, including Alteco® LPS Adsorber.
- Treatment with an investigational medicinal product for any indication within the last 30 days before enrolment in the clinical investigation.
- Pregnancy.
- Contraindications to the use heparin or protamine
- Other abdominal inflammatory conditions
- Perforation of hollow organ linked to trauma within 48 hours before enrolment in the clinical investigation.
- Laparotomy reveals isolated gastric ulcer.
- Subjects and/or their immediate family are directly affiliated to investigative site personnel in this clinical investigation. (Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted).
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Finland2 sites
Kuopio University Hospital
Kuopio, 70210
Tampere University Hospital
Tampere, 33521
Norway2 sites
Haukeland Universitetssykehus
Bergen, 5021
Oslo Universitetssykehus
Oslo, 0372
Sweden2 sites
Linköping University Hospital
Linköping, SE-58185
Uppsala University Hospital
Uppsala, SE-751 81
About this study
Official title: Abdominal Septic Shock - Endotoxin Adsorption Treatment (ASSET) - a Double-Blind, Randomized Placebo-Controlled Clinical Investigation With Alteco® LPS Adsorber
The primary objective of this clinical investigation is to investigate the feasibility and possible benefits of the Alteco® LPS Adsorber in treating patients with septic shock with presumed endotoxemia of abdominal or urogenital origin.
Read the detailed description
OVERALL CLINICAL INVESTIGATION DESIGN:
This is a multicentre, stratified, parallel, double-blinded, randomized, feasibility clinical investigation of the Alteco® LPS Adsorber.
Subjects will be enrolled in an adaptive fashion with up to two interim analyses, and the possibility of recruiting additional patients, in order to establish an indication of the feasibility of treating a target population of subjects with septic shock and endotoxemia.
Subjects will be stratified in accordance with the origin of their infection, i.e. abdominal or urogenital sepsis. Subjects in each stratum will receive either:
- LPS Adsorber group (i.e. investigational medical device [IMD] group): current best practice in combination with Alteco® LPS Adsorber treatment, OR
- Placebo device group (i.e. comparator group): current best practice in combination with placebo adsorber treatment.
Allocation to either treatment arm will be performed in a 1:1 ratio. Upon enrolment (i.e. pre-treatment phase), subjects admitted to the ICU with suspected endotoxemia will be screened for fulfilment of the "Illness Severity Criteria" confirming early stage severe sepsis.
Within six (6) hours of enrolment, subjects who also fulfil the "Treatment Criteria" confirming septic shock will be eligible for randomization.
Randomization to either of the treatment groups will be performed as close as possible to start of treatment with the Alteco® LPS Adsorber or placebo device.
Treatment with LPS Adsorber or placebo device must be initiated within six (6) hours (Day 1) following fulfilment of the "Treatment Criteria". A second device treatment will be performed 24 hours after the end of the first device treatment on Day 2, as long there is no evidence that treatment with the investigational device will not be beneficial or will indicate an unnecessary risk for subjects (for example, the subject is vasopressor support-free).
Initially: 20 abdominal sepsis subjects (Stratum A) and 12 urogenital sepsis subjects (Stratum B) Optional: additional 12 subjects (abdominal, urogenital or both) after interim analysis decision.
- Conditions
- Septic Shock
- Being tested
- Alteco LPS Adsorber, Placebo
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alteco LPS AdsorberDevice
Alteco® LPS Adsorber is a Class IIa medical device developed in accordance with existing international standards. Alteco® LPS Adsorber does not contain any pharmaceutical or toxic components.
Alteco® LPS Adsorber is used for the adsorption of LPS as endotoxins. The capturing component is a specially designed synthetic peptide developed for adsorption of endotoxin. The capturing component has high affinity to Lipid A, i.e. a constant component in the endotoxin molecule, which ensures efficient reduction of endotoxins from different bacterial species.
PlaceboDevice
Exactly the same as Alteco LPS Adsorber but no peptide component has been attached to the matrix (i.e. there is no adsorber functionality)
| Study group | Role | What they receive |
|---|---|---|
| Alteco LPS Adsorber | Active comparator | Hemoperfusion and Standard therapy Receives: Device: Alteco LPS Adsorber |
| Placebo | Placebo comparator | Placebo and Standard therapy. The placebo comparator device differs from Alteco® LPS Adsorber only in that no peptide component (i.e. active component) has been attached to the matrix. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of all reported USADEs and ASADEs.
Measured: 6-28 days
Secondary outcomes (14)
Relative change from baseline in plasma endotoxin (p-endotoxin) levels during (i.e. at 2 hours) and immediately after end (i.e. at 6 hours) of treatment with device, on both Day 1 and Day 2.
Measured: 2 days
Relative change from baseline in SOFA score
Measured: 6-28 days
Relative change from baseline in renal function
Renal function is assessed by: S-creatinine, P-Cystatin C, P-Urea, eGFR, KDIGO stage, Fluid balance, and Daily urinary output
Measured: 6-28 days
Relative change from baseline in liver function
Liver function is assessed by: Prothrombin complex INR, P-Albumin, and P-Bilirubin
Measured: 6-28 days
Relative change from baseline in circulatory support
Circulatory support is assessed by: Vasopressor load, Inotropic score, MAP, Vasopressor dependence index, P-Lactate, Blood gas, and Vasopressor-free days.
Measured: 6-28 days
Relative change from baseline in respiratory support
Respiratory support is assessed by: PaO2, FiO2 and PaO2/FiO2 ratio, Positive and expiratory pressure, Peak pressure, Tidal volume and minute volume, Respiratory rate, Pa CO2, Respiratory support need as measured by means of ventilator-free days until day for ICU discharge
Measured: 6-28 days
Relative change from baseline in ICU mortality
Measured: 6-28 days
Relative change from baseline in ICU length of stay
Measured: 6-28 days
Clinical outcome during stay at Hospital following ICU-discharge of the total extension of renal support
Measured: 6-28 days
Clinical outcome during stay at Hospital following ICU-discharge of 28-day mortality
Measured: 6-28 days
Clinical outcome during stay at Hospital following ICU-discharge of hospital length of stay up to 28 days
Measured: 6-28 days
Levels of inflammatory response biomarkers
Measured: 6-28 days
Determination of the molecular components extracted from blood circulation and captured in Alteco® LPS Adsorber.
This is an exploratory outcome, there will be a screening of which molecules that have been captured.
Measured: 6-28 days
Characterization of all reported AEs (regardless of attribution), ADEs, and device deficiencies
Measured: 6-28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2015 (estimated)
- Study startSep 2015
- Primary completion28 Apr 2017
- Study completion28 Apr 2017
Why it stopped: Problem to find eligible patients to include
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alteco Medical AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TFS Trial Form Support, Uppsala University
- Responsible party
- Sponsor
- Investigators
- Sten Rubertsson, Professor, Principal investigator, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02335723
- Sponsor's protocol ID
- ALT-CI-01
- Acronym
- ASSET
- Status last verified
- Mar 2018
- First submitted
- 28 Nov 2014
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lipcsey M, Tenhunen J, Pischke SE, Kuitunen A, Flaatten H, De Geer L, Sjolin J, Frithiof R, Chew MS, Bendel S, Kawati R, Larsson A, Mollnes TE, Tonnessen TI, Rubertsson S. Endotoxin Removal in Septic Shock with the Alteco LPS Adsorber Was Safe But Showed no Benefit Compared to Placebo in the Double-Blind Randomized Controlled Trial-the Asset Study. Shock. 2020 Aug;54(2):224-231. doi: 10.1097/SHK.0000000000001503.
PubMed 31880758Lipcsey M, Tenhunen J, Sjolin J, Frithiof R, Bendel S, Flaatten H, Kawati R, Kuitunen A, Tonnessen TI, Rubertsson S. Abdominal Septic Shock - Endotoxin Adsorption Treatment (ASSET) - endotoxin removal in abdominal and urogenital septic shock with the Alteco(R) LPS Adsorber: study protocol for a double-blinded, randomized placebo-controlled trial. Trials. 2016 Dec 8;17(1):587. doi: 10.1186/s13063-016-1723-4.
PubMed 27931259
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Septic Shock - Endotoxin Adsorption Treatment (ASSET) - a Double-Blind, Randomized Placebo-Controlled Clinical Investigation With Alteco® LPS Adsorber
- ClinicalTrials.gov ID
- NCT02335723
- Acronym / sponsor ID
- ASSET / ALT-CI-01
- Conditions
- Septic Shock
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Problem to find eligible patients to include
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Alteco Medical ABIndustry (pharma, biotech, devices)
- Collaborators
- TFS Trial Form Support, Uppsala University
- Study start
- Sep 2015
- Primary completion
- 28 Apr 2017 (actual)
- Study completion
- 28 Apr 2017 (actual)
- First posted
- 12 Jan 2015 (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 primary objective of this clinical investigation is to investigate the feasibility and possible benefits of the Alteco® LPS Adsorber in treating patients with septic shock with presumed endotoxemia of abdominal or urogenital origin.
Detailed description
OVERALL CLINICAL INVESTIGATION DESIGN:
This is a multicentre, stratified, parallel, double-blinded, randomized, feasibility clinical investigation of the Alteco® LPS Adsorber.
Subjects will be enrolled in an adaptive fashion with up to two interim analyses, and the possibility of recruiting additional patients, in order to establish an indication of the feasibility of treating a target population of subjects with septic shock and endotoxemia.
Subjects will be stratified in accordance with the origin of their infection, i.e. abdominal or urogenital sepsis. Subjects in each stratum will receive either:
- LPS Adsorber group (i.e. investigational medical device [IMD] group): current best practice in combination with Alteco® LPS Adsorber treatment, OR
- Placebo device group (i.e. comparator group): current best practice in combination with placebo adsorber treatment.
Allocation to either treatment arm will be performed in a 1:1 ratio. Upon enrolment (i.e. pre-treatment phase), subjects admitted to the ICU with suspected endotoxemia will be screened for fulfilment of the "Illness Severity Criteria" confirming early stage severe sepsis.
Within six (6) hours of enrolment, subjects who also fulfil the "Treatment Criteria" confirming septic shock will be eligible for randomization.
Randomization to either of the treatment groups will be performed as close as possible to start of treatment with the Alteco® LPS Adsorber or placebo device.
Treatment with LPS Adsorber or placebo device must be initiated within six (6) hours (Day 1) following fulfilment of the "Treatment Criteria". A second device treatment will be performed 24 hours after the end of the first device treatment on Day 2, as long there is no evidence that treatment with the investigational device will not be beneficial or will indicate an unnecessary risk for subjects (for example, the subject is vasopressor support-free).
Initially: 20 abdominal sepsis subjects (Stratum A) and 12 urogenital sepsis subjects (Stratum B) Optional: additional 12 subjects (abdominal, urogenital or both) after interim analysis decision.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alteco LPS Adsorber | Active comparator | Device: Alteco LPS AdsorberHemoperfusion and Standard therapy |
| Placebo | Placebo comparator | Device: PlaceboPlacebo and Standard therapy. The placebo comparator device differs from Alteco® LPS Adsorber only in that no peptide component (i.e. active component) has been attached to the matrix. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Illness severity criteria: At enrolment subjects must meet inclusion criteria #1 through #3 listed below to be eligible to enter the clinical investigation:
- Subjects must have suspected severe infection of abdominal or urogenital origin for which the subject is receiving intravenous antimicrobial therapy as the main reason for organ support
- Subjects, males or females, must be 18 years or older.
- Subjects or legally acceptable representatives, as appropriate, are willing and able to provide signed informed consent.
- Treatment criteria: Prior to randomization, subjects must meet all inclusion criteria (#4 through #7) listed below to be assigned to a treatment group:
Key exclusion criteria (20 listed)
- Subjects who meet any of the exclusion criteria listed below will NOT be permitted to enter the clinical investigation: Sepsis-induced organ dysfunction for longer than 12 hours prior to the time-point for achieving "Illness severity criteria fulfilled"
- Vasopressor therapy (at any dose) for longer than 12 hours (not included the time spent in the operation theatre) prior to the start of treatment with the investigational device.
- Pre-existing uncorrectable medical condition as:
- Extreme illness, i.e. subjects is moribund and death is perceived to be imminent (within 24 hours).
- Recent or current participation (≤ 30 days) in another interventional sepsis trial.
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 |
|---|---|---|
| Alteco LPS AdsorberAlteco® LPS Adsorber is a Class IIa medical device developed in accordance with existing international standards. Alteco® LPS Adsorber does not contain any pharmaceutical or toxic components. Alteco® LPS Adsorber is used for the adsorption of LPS as endotoxins. The capturing component is a specially designed synthetic peptide developed for adsorption of endotoxin. The capturing component has high affinity to Lipid A, i.e. a constant component in the endotoxin molecule, which ensures efficient reduction of endotoxins from different bacterial species. | Device | Alteco LPS Adsorber |
| PlaceboExactly the same as Alteco LPS Adsorber but no peptide component has been attached to the matrix (i.e. there is no adsorber functionality) | Device | Placebo |
Primary outcome
Characterization of all reported USADEs and ASADEs.
Time frame: 6-28 days
14 secondary outcomes
Relative change from baseline in plasma endotoxin (p-endotoxin) levels during (i.e. at 2 hours) and immediately after end (i.e. at 6 hours) of treatment with device, on both Day 1 and Day 2.
Time frame: 2 days
Relative change from baseline in SOFA score
Time frame: 6-28 days
Relative change from baseline in renal function
Time frame: 6-28 days
Relative change from baseline in liver function
Time frame: 6-28 days
Relative change from baseline in circulatory support
Time frame: 6-28 days
Relative change from baseline in respiratory support
Time frame: 6-28 days
Relative change from baseline in ICU mortality
Time frame: 6-28 days
Relative change from baseline in ICU length of stay
Time frame: 6-28 days
Clinical outcome during stay at Hospital following ICU-discharge of the total extension of renal support
Time frame: 6-28 days
Clinical outcome during stay at Hospital following ICU-discharge of 28-day mortality
Time frame: 6-28 days
Clinical outcome during stay at Hospital following ICU-discharge of hospital length of stay up to 28 days
Time frame: 6-28 days
Levels of inflammatory response biomarkers
Time frame: 6-28 days
Determination of the molecular components extracted from blood circulation and captured in Alteco® LPS Adsorber.
Time frame: 6-28 days
Characterization of all reported AEs (regardless of attribution), ADEs, and device deficiencies
Time frame: 6-28 days
Results and safety
The study was stopped early (reason given: Problem to find eligible patients to include). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
- Derived from this study: PubMed 31880758Lipcsey M, Tenhunen J, Pischke SE, Kuitunen A, Flaatten H, De Geer L, Sjolin J, Frithiof R, Chew MS, Bendel S, Kawati R, Larsson A, Mollnes TE, Tonnessen TI, Rubertsson S. Endotoxin Removal in Septic Shock with the Alteco LPS Adsorber Was Safe But Showed no Benefit Compared to Placebo in the Double-Blind Randomized Controlled Trial-the Asset Study. Shock. 2020 Aug;54(2):224-231. doi: 10.1097/SHK.0000000000001503.
- Derived from this study: PubMed 27931259Lipcsey M, Tenhunen J, Sjolin J, Frithiof R, Bendel S, Flaatten H, Kawati R, Kuitunen A, Tonnessen TI, Rubertsson S. Abdominal Septic Shock - Endotoxin Adsorption Treatment (ASSET) - endotoxin removal in abdominal and urogenital septic shock with the Alteco(R) LPS Adsorber: study protocol for a double-blinded, randomized placebo-controlled trial. Trials. 2016 Dec 8;17(1):587. doi: 10.1186/s13063-016-1723-4.
- Individual participant dataSharing planned: No
Related trials for Septic Shock
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis
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.
Sten Rubertsson, Professor principal investigator
Uppsala University Hospital
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alteco LPS Adsorber in people with Septic Shock, run by Alteco Medical AB at 6 sites in 3 countries.
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 9 inclusion and 20 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: stopped early, as of the sponsor's last update on 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Finland, Norway, Sweden. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Problem to find eligible patients to include). Results are not available in the source record.
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?
Characterization of all reported USADEs and ASADEs. (time frame: 6-28 days). 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 NCT02335723, which also lists 2 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 7 Mar 2018.