Shock, SepticCOMPACT-2NCT01639664
COMPACT 2 - COMbining Plasma-filtration and Adsorption Clinical Trial 2
A study testing High doses CPFA in people with Shock, Septic, run by Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva at 13 sites in Italy.
Trial summary
The study objective is to clarify whether the application of high doses CPFA (coupled plasma-filtration adsorption) in addition to the current clinical practice is able to reduce hospital mortality in septic shock patients in intensive care unit (ICU). Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Shock, Septic
- What is being tested?
- High doses CPFA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 13 sitesItaly
- Study dates
- Sep 2013to 23 Oct 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients admitted to the ICU in septic shock
- All patients that develop septic shock while in the ICU
Who cannot join
- Age less than 14 years
- Pregnancy
- Estimated life expectancy (due to comorbidities) less than 90 days
- Presence of relative or absolute contraindications to CPFA
- Admission from an other ICU where the patient remained for more than 24 hours
- Absence of informed consent
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Italy13 sites
Ospedale SS. Antonio e Biagio e C. Arrigo, Servizio Anestesia, Rianimazione e Terapia Antalgica
Alessandria, Piedmont, 15100
Ospedale Maurizio Bufalini, UO Anestesia Terapia Intensiva
Cesena, Emilia-Romagna, 47023
Ospedale Maggiore
Chieri, Piedmont, 10023
AOU Careggi
Florence, Tuscany, 50134
Ospedale Morgagni-Pierantoni, U.O. Anestesia e Rianimazione
Forlì, Emilia-Romagna, 47100
Ospedale A. Manzoni, U.O. Anestesia e Rianimazione 1
Lecco, Lombardy, 23900
Ospedale Madonna delle Grazie, U.O. di Anestesia e Rianimazione
Matera, Basilicate, 75100
Ospedale Santa Croce
Moncalieri, Piedmont, 10027
Ospedali Riuniti Valdichiana Senese, U.O. di Anestesia e Rianimazione
Montepulciano, Tuscany, 53045
Ospedale SS. Cosma e Damiano, Servizio Anestesia e Rianimazione
Pescia, Tuscany, 51017
Ospedale Alta Val d'Elsa, Terapia Intensiva
Poggibonsi, Tuscany, 53036
CTO Maria Adelaide, I Servizio Anestesia e Rianimazione
Turin, Piedmont, 10126
Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione B-DEA
Turin, Piedmont, 10148
About this study
Official title: COMPACT (COMbining Plasma-filtration and Adsorption Clinical Trial): Efficacy and Safety of High Doses CPFA (Coupled Plasma Filtration Adsorption) for Septic Shock in the ICU
The study objective is to clarify whether the application of high doses CPFA (coupled plasma-filtration adsorption) in addition to the current clinical practice is able to reduce hospital mortality in septic shock patients in intensive care unit (ICU).
Read the detailed description
Septic shock is a life-threatening clinical condition characterized by cardiovascular failure as a consequence of infection. Septic shock frequently causes multi-organ failure in the ICU. For this reason the extracorporeal therapies for the treatment of renal failure have become widespread in the ICU and, at the same time, new extracorporeal depurative techniques have been developed for the removal of inflammatory mediators. One of these techniques is CPFA (coupled plasma-filtration adsorption) that uses a sorbent once the separation between plasma and blood has been obtained with a plasma filter. The study objective is to clarify whether the application of high doses CPFA in addition to the current clinical practice is able to reduce hospital mortality in septic shock patients in intensive care unit. Secondary objectives are the resolution of septic shock and the reduction of ICU LOS (length of stay).
- Conditions
- Shock, Septic
- Being tested
- High doses CPFA
- Keywords
- septic shock, intensive care medicine, coupled plasma filtration-adsorption
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High doses CPFADevice
High doses CPFA (coupled plasma-filtration adsorption) with AMPLYA™ (BELLCO ITALY): >0.20 L/kg/day of plasma treated in the first 3 days after randomization.
| Study group | Role | What they receive |
|---|---|---|
| High doses CPFA | Experimental | High doses CPFA (coupled plasma-filtration adsorption) with AMPLYA™ (BELLCO ITALY): >0.20 L/kg/day of plasma treated in the first 3 days after randomization. Receives: Device: High doses CPFA |
| Control group | No intervention | standard practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Mortality
For patients discharged to other hospital, it will be intended as mortality at the discharge from the latest hospital in which the patients stayed.
Measured: At the discharge from the latest hospital (on average 30.3 days)
Secondary outcomes (3)
Mortality Within 90 Days From Randomization
Measured: 90 days from randomization
ICU LOS Reduction Measured as Days Not Spent in the ICU During the First 30 Days From Randomization
Measured: 30 days from randomization
Septic Shock Resolution Measured as Number of Days Free of Vasoactive Drugs From Randomization
Measured: 15 days from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2012 (estimated)
- Study startSep 2013
- Primary completion23 Oct 2017
- Study completion23 Oct 2017
Why it stopped: The interim analysis requested by the EDSMC shows higher mortality for the CPFA group compared to the controls, particularly in the first days of treatment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Shock, SepticStudies 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
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
- Sponsor type
- University, hospital or other
- Collaborators
- Bellco Srl Mirandola, Italy
- Responsible party
- Sponsor
- Investigators
- Sergio Livigni, MD, Principal investigator, Ospedale San Giovanni Bosco, Torino, ITALY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01639664
- Sponsor's protocol ID
- 6233
- Acronym
- COMPACT-2
- Status last verified
- Mar 2017
- First submitted
- 6 Jul 2012
- Last updated
- 5 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Garbero E, Livigni S, Ferrari F, Finazzi S, Langer M, Malacarne P, Meca MCC, Mosca S, Olivieri C, Pozzato M, Rossi C, Tavola M, Terzitta M, Viaggi B, Bertolini G; GiViTI. High dose coupled plasma filtration and adsorption in septic shock patients. Results of the COMPACT-2: a multicentre, adaptive, randomised clinical trial. Intensive Care Med. 2021 Nov;47(11):1303-1311. doi: 10.1007/s00134-021-06501-3. Epub 2021 Oct 3.
PubMed 34601619Milla P, Viterbo ML, Mosca S, Arpicco S. Chemical and microbiological stability, anticoagulant efficacy and toxicity of 35 and 90 mM trisodium citrate solutions stored in plastic syringes. Eur J Hosp Pharm. 2018 Oct;25(e2):e83-e87. doi: 10.1136/ejhpharm-2016-001094. Epub 2017 Jan 13.
PubMed 31157074
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPACT (COMbining Plasma-filtration and Adsorption Clinical Trial): Efficacy and Safety of High Doses CPFA (Coupled Plasma Filtration Adsorption) for Septic Shock in the ICU
- ClinicalTrials.gov ID
- NCT01639664
- Acronym / sponsor ID
- COMPACT-2 / 6233
- Conditions
- Shock, Septic
- Keywords
- septic shock, intensive care medicine, coupled plasma filtration-adsorption
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The interim analysis requested by the EDSMC shows higher mortality for the CPFA group compared to the controls, particularly in the first days of treatment.
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Gruppo Italiano per la Valutazione degli Interventi in Terapia IntensivaUniversity, hospital or other
- Collaborators
- Bellco Srl Mirandola, Italy
- Study start
- Sep 2013
- Primary completion
- 23 Oct 2017 (actual)
- Study completion
- 23 Oct 2017 (actual)
- First posted
- 13 Jul 2012 (estimated)
- Results
- Posted 5 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study objective is to clarify whether the application of high doses CPFA (coupled plasma-filtration adsorption) in addition to the current clinical practice is able to reduce hospital mortality in septic shock patients in intensive care unit (ICU).
Detailed description
Septic shock is a life-threatening clinical condition characterized by cardiovascular failure as a consequence of infection. Septic shock frequently causes multi-organ failure in the ICU. For this reason the extracorporeal therapies for the treatment of renal failure have become widespread in the ICU and, at the same time, new extracorporeal depurative techniques have been developed for the removal of inflammatory mediators. One of these techniques is CPFA (coupled plasma-filtration adsorption) that uses a sorbent once the separation between plasma and blood has been obtained with a plasma filter. The study objective is to clarify whether the application of high doses CPFA in addition to the current clinical practice is able to reduce hospital mortality in septic shock patients in intensive care unit. Secondary objectives are the resolution of septic shock and the reduction of ICU LOS (length of stay).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High doses CPFA | Experimental | Device: High doses CPFAHigh doses CPFA (coupled plasma-filtration adsorption) with AMPLYA™ (BELLCO ITALY): >0.20 L/kg/day of plasma treated in the first 3 days after randomization. |
| Control group | No intervention | –standard practice |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All patients admitted to the ICU in septic shock
- All patients that develop septic shock while in the ICU
Key exclusion criteria (6 listed)
- Age less than 14 years
- Pregnancy
- Estimated life expectancy (due to comorbidities) less than 90 days
- Presence of relative or absolute contraindications to CPFA
- Admission from an other ICU where the patient remained for more than 24 hours
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 |
|---|---|---|
| High doses CPFAHigh doses CPFA (coupled plasma-filtration adsorption) with AMPLYA™ (BELLCO ITALY): >0.20 L/kg/day of plasma treated in the first 3 days after randomization. | Device | High doses CPFA |
Primary outcome
Hospital Mortality
Time frame: At the discharge from the latest hospital (on average 30.3 days)
For patients discharged to other hospital, it will be intended as mortality at the discharge from the latest hospital in which the patients stayed.
3 secondary outcomes
Mortality Within 90 Days From Randomization
Time frame: 90 days from randomization
ICU LOS Reduction Measured as Days Not Spent in the ICU During the First 30 Days From Randomization
Time frame: 30 days from randomization
Septic Shock Resolution Measured as Number of Days Free of Vasoactive Drugs From Randomization
Time frame: 15 days from randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34601619Garbero E, Livigni S, Ferrari F, Finazzi S, Langer M, Malacarne P, Meca MCC, Mosca S, Olivieri C, Pozzato M, Rossi C, Tavola M, Terzitta M, Viaggi B, Bertolini G; GiViTI. High dose coupled plasma filtration and adsorption in septic shock patients. Results of the COMPACT-2: a multicentre, adaptive, randomised clinical trial. Intensive Care Med. 2021 Nov;47(11):1303-1311. doi: 10.1007/s00134-021-06501-3. Epub 2021 Oct 3.
- Derived from this study: PubMed 31157074Milla P, Viterbo ML, Mosca S, Arpicco S. Chemical and microbiological stability, anticoagulant efficacy and toxicity of 35 and 90 mM trisodium citrate solutions stored in plastic syringes. Eur J Hosp Pharm. 2018 Oct;25(e2):e83-e87. doi: 10.1136/ejhpharm-2016-001094. Epub 2017 Jan 13.
- GiViTI web siteLink 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.
Sergio Livigni, MD principal investigator
Ospedale San Giovanni Bosco, Torino, ITALY
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High doses CPFA in people with Shock, Septic, run by Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva at 13 sites in Italy.
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 2 inclusion and 6 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 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Italy. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hospital Mortality (time frame: At the discharge from the latest hospital (on average 30.3 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 NCT01639664, 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 5 Sep 2021.