Shock, SepticNCT00332371
COMPACT - COMbining Plasma-filtration and Adsorption Clinical Trial
A study testing CPFA (Coupled Plasma Filtration Adsorption) in people with Shock, Septic, run by Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva at 19 sites in Italy.
Trial summary
The study objective is to clarify whether the application of CPFA (coupled plasma-filtration adsorption) in addition to the current clinical practice is able to reduce mortality and prevent organ failures in septic shock patients in intensive care unit (ICU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock, Septic
- What is being tested?
- CPFA (Coupled Plasma Filtration Adsorption)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 19 sitesItaly
- Study dates
- Dec 2006to Jul 2011
- 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
- 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 18 years
- Pregnancy
- Cardiopulmonary resuscitation
- Cerebral coma
- Metastatic cancer
- Presence of relative or absolute contraindications to CPFA
Show all 10Show fewer
- Estimated life expectancy less than 2 weeks
- Already included in the study
- Admission from an other ICU where the patient remained for more than 24 hours
- Absence of informed consent
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Italy19 sites
Ospedale SS. Antonio e Biagio e C. Arrigo
Alessandria, AL, 15100
Ospedale Regionale della Valle d'Aosta, Servizio Anestesia e Rianimazione
Aosta, AO, 11100
Ospedali Riuniti, I Servizio Anestesia e Rianimazione
Bergamo, BG, 24128
Ospedale Spedali Civili, II Servizio di Anestesia e Rianimazione
Brescia, BS, 25125
Ospedale Vittorio Emanuele, II Servizio di Anestesia e Rianimazione
Catania, CT, 95100
Ospedale Careggi - Villa Monna Tessa, TI Polifunzionale e Post-trapianto
Florence, FI, 50134
Ospedale S. Giovanni di Dio ASL 10, Servizio Anestesia e Rianimazione
Florence, FI, 50143
Ospedale Morgagni-Pierantoni, U.O. Anestesia e Rianimazione
Forlì, FC, 47100
Ospedale Civile
Imperia, IM, 18100
Ospedale Civile Regione Piemonte ASL 9, Servizio Anestesia e Rianimazione
Ivrea, TO, 10015
Ospedale A. Manzoni, U.O. Anestesia e Rianimazione 1
Lecco, LC, 23900
Ospedale Madonna delle Grazie, U.O. Anestesia e Rianimazione
Matera, MT, 75100
Ospedale di S. Chiara, VI U.O. di Anestesia, Rianimazione e Pronto Soccorso
Pisa, PI, 56100
Ospedale Policlinico San Pietro, Servizio Anestesia e Rianimazione
Ponte San Pietro, BG, 24036
European Hospital
Roma, RM, 00149
Ospedale San Camillo Forlanini
Roma, RM, 00152
Ospedale Civile, Servizio Anestesia e Rianimazione
Sanremo, IM, 18038
Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione B-DEA
Torino, TO, 10148
Ospedale Policlinico San Marco, Terapia Intensiva
Zingonia, BG, 24040
About this study
Official title: COMPACT (COMbining Plasma-filtration and Adsorption Clinical Trial): Efficacy and Safety of CPFA (Coupled Plasma Filtration Adsorption) for Septic Shock in the ICU
The study objective is to clarify whether the application of CPFA (coupled plasma-filtration adsorption) in addition to the current clinical practice is able to reduce mortality and prevent organ failures 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 CPFA in addition to the current clinical practice is able to reduce mortality and prevent organ failures in septic shock patients in intensive care unit.
- Conditions
- Shock, Septic
- Being tested
- CPFA (Coupled Plasma Filtration Adsorption)
- Keywords
- Intensive Care, Shock, Septic, Adsorption, Sorption Detoxification
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPFA (Coupled Plasma Filtration Adsorption)Device
Also called Coupled Plasma Filtration Adsorption
CPFA is a specific method for the treatment of sepsis.
It consists of:
- a plasma-filter (polyethersulfone 0.45 m2 with a cutoff of approx 800 kDa)
- a hemofilter (polyethersulfone 1,4 m2)
- a cartridge (contains approximately 140 ml of hydrophobic styrenic resin)
The kit is lodged in the Bellco "Lynda" machine (Bellco Mirandola, Italy). The treatment consists of the separation of plasma from the whole blood with adsorption of the inflammatory mediators and cytokines from the plasma, and a subsequent purification step by way of a hemofilter.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: CPFA (Coupled Plasma Filtration Adsorption) |
| 2 | No intervention | Not described |
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
Secondary outcomes (3)
Mortality within 90 days from randomization
Measured: 90 days from randomization
New organ failures (assessed through SOFA score)
Measured: Within ICU stay
Days not spent in the ICU during the first 30 days from randomization
Measured: 30 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 posted1 Jun 2006 (estimated)
- Study startDec 2006
- Primary completionDec 2010
- Study completionJul 2011
Why it stopped: The study was prematurely interrupted for futility.
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 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
- 184 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
- NCT00332371
- Sponsor's protocol ID
- 4817
- Other IDs
- ISRCTN24534559
- Status last verified
- Jul 2012
- First submitted
- 31 May 2006
- Last updated
- 9 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Livigni S, Bertolini G, Rossi C, Ferrari F, Giardino M, Pozzato M, Remuzzi G; GiViTI: Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva (Italian Group for the Evaluation of Interventions in Intensive Care Medicine) is an independent collaboration network of Italian Intensive Care units. Efficacy of coupled plasma filtration adsorption (CPFA) in patients with septic shock: a multicenter randomised controlled clinical trial. BMJ Open. 2014 Jan 8;4(1):e003536. doi: 10.1136/bmjopen-2013-003536.
PubMed 24401721
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2012. 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 CPFA (Coupled Plasma Filtration Adsorption) for Septic Shock in the ICU
- ClinicalTrials.gov ID
- NCT00332371
- Acronym / sponsor ID
- 4817
- Conditions
- Shock, Septic
- Keywords
- Intensive Care, Shock, Septic, Adsorption, Sorption Detoxification
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was prematurely interrupted for futility.
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Gruppo Italiano per la Valutazione degli Interventi in Terapia IntensivaUniversity, hospital or other
- Collaborators
- Bellco Srl Mirandola, Italy
- Study start
- Dec 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 1 Jun 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.
The study objective is to clarify whether the application of CPFA (coupled plasma-filtration adsorption) in addition to the current clinical practice is able to reduce mortality and prevent organ failures 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 CPFA in addition to the current clinical practice is able to reduce mortality and prevent organ failures in septic shock patients in intensive care unit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: CPFA (Coupled Plasma Filtration Adsorption) |
| 2 | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 (10 listed)
- Age less than 18 years
- Pregnancy
- Cardiopulmonary resuscitation
- Cerebral coma
- Metastatic cancer
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 |
|---|---|---|
| CPFA (Coupled Plasma Filtration Adsorption)Also: Coupled Plasma Filtration AdsorptionCPFA is a specific method for the treatment of sepsis. It consists of: 1. a plasma-filter (polyethersulfone 0.45 m2 with a cutoff of approx 800 kDa) 2. a hemofilter (polyethersulfone 1,4 m2) 3. a cartridge (contains approximately 140 ml of hydrophobic styrenic resin) The kit is lodged in the Bellco "Lynda" machine (Bellco Mirandola, Italy). The treatment consists of the separation of plasma from the whole blood with adsorption of the inflammatory mediators and cytokines from the plasma, and a subsequent purification step by way of a hemofilter. | Device | 1 |
Primary outcome
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)
Time frame: At the discharge from the latest hospital
3 secondary outcomes
Mortality within 90 days from randomization
Time frame: 90 days from randomization
New organ failures (assessed through SOFA score)
Time frame: Within ICU stay
Days not spent in the ICU during the first 30 days from randomization
Time frame: 30 days from randomization
Results and safety
The study was stopped early (reason given: The study was prematurely interrupted for futility.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2012.
- Derived from this study: PubMed 24401721Livigni S, Bertolini G, Rossi C, Ferrari F, Giardino M, Pozzato M, Remuzzi G; GiViTI: Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva (Italian Group for the Evaluation of Interventions in Intensive Care Medicine) is an independent collaboration network of Italian Intensive Care units. Efficacy of coupled plasma filtration adsorption (CPFA) in patients with septic shock: a multicenter randomised controlled clinical trial. BMJ Open. 2014 Jan 8;4(1):e003536. doi: 10.1136/bmjopen-2013-003536.
- GiViTI official web siteLink provided by the sponsor.
Related trials for Shock, Septic
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.
Sergio Livigni, MD principal investigator
Ospedale San Giovanni Bosco, Torino, ITALY
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPFA (Coupled Plasma Filtration Adsorption) in people with Shock, Septic, run by Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva at 19 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 10 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 9 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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?
The study was stopped early (reason given: The study was prematurely interrupted for futility.). 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?
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) (time frame: At the discharge from the latest hospital). 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 NCT00332371, 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 9 Jul 2012.