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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.
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| Name | Class |
|---|---|
| Bellco Srl Mirandola, Italy | INDUSTRY |
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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control group | No Intervention | standard practice |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High doses CPFA | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the discharge from the latest hospital (on average 30.3 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality Within 90 Days From Randomization | 90 days from randomization | |
| ICU LOS Reduction Measured as Days Not Spent in the ICU During the First 30 Days From Randomization | 30 days from randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sergio Livigni, MD | Ospedale San Giovanni Bosco, Torino, ITALY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Madonna delle Grazie, U.O. di Anestesia e Rianimazione | Matera | Basilicate | 75100 | Italy | ||
| Ospedale Maurizio Bufalini, UO Anestesia Terapia Intensiva |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34601619 | Derived | 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. | |
| 31157074 |
| Label | URL |
|---|---|
| GiViTI web site | View source |
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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. This result raise concern that the use of CPFA may cause harm or worsen the clinical condition of septic shock patients. For this reason we did not conclude the participant enrollment of the study.
The COMPACT-2 study has been prematurely terminated as from 23/10/2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | High Doses CPFA | 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 and on each of the subsequent days in which the patient is still in septic-shock condition. |
| FG001 | Control Group | standard practice |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High Doses CPFA | 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. |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | At the discharge from the latest hospital (on average 30.3 days) |
|
All patients showing a serious adverse event probably related to the experimental technique were monitored until the symptoms disappear, or the laboratory values return to normal, or until a reasonable explanation of the observed changes emerges, or until death. In the last case, the pathologist report should be provided, whenever possible. Patients were monitored up to 90 days. All adverse events were recorded on an ad hoc form.
In the field of intensive care medicine, the incidence of critical events during the stay in the ICU is high by definition. For this reason, only unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease probably related to the experimental technique has been taken into account. Non-treatment-related Adverse Events were not monitored.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Doses CPFA | 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. High doses CPFA: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Guido Bertolini | Istituto di Ricerche Farmacologiche Mario Negri IRCCS | 035 4535 313 | guido.bertolini@marionegri.it |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 4, 2013 | Oct 27, 2017 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| Septic Shock Resolution Measured as Number of Days Free of Vasoactive Drugs From Randomization | 15 days from randomization |
| Cesena |
| Emilia-Romagna |
| 47023 |
| Italy |
| Ospedale Morgagni-Pierantoni, U.O. Anestesia e Rianimazione | Forlì | Emilia-Romagna | 47100 | Italy |
| Ospedale A. Manzoni, U.O. Anestesia e Rianimazione 1 | Lecco | Lombardy | 23900 | Italy |
| Ospedale SS. Antonio e Biagio e C. Arrigo, Servizio Anestesia, Rianimazione e Terapia Antalgica | Alessandria | Piedmont | 15100 | Italy |
| Ospedale Maggiore | Chieri | Piedmont | 10023 | Italy |
| Ospedale Santa Croce | Moncalieri | Piedmont | 10027 | Italy |
| CTO Maria Adelaide, I Servizio Anestesia e Rianimazione | Turin | Piedmont | 10126 | Italy |
| Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione B-DEA | Turin | Piedmont | 10148 | Italy |
| AOU Careggi | Florence | Tuscany | 50134 | Italy |
| Ospedali Riuniti Valdichiana Senese, U.O. di Anestesia e Rianimazione | Montepulciano | Tuscany | 53045 | Italy |
| Ospedale SS. Cosma e Damiano, Servizio Anestesia e Rianimazione | Pescia | Tuscany | 51017 | Italy |
| Ospedale Alta Val d'Elsa, Terapia Intensiva | Poggibonsi | Tuscany | 53036 | Italy |
| Derived |
| Milla 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. |
Standard practice
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Length of stay before ICU admission | Mean | Standard Deviation | days |
|
| SAPS II | The Simplified Acute Physiology Score (SAPS II) is a severity score and mortality estimation tool developed from a large sample of medical and surgical patients in North America and Europe. SAPS II consists of 17 variables: 12 physiological variables, age, type of admission, and 3 variables related to underlying disease. For the physiological variables, the worst value during the first 24 hours of ICU admission is used for the calculation. The SAPS II results in a point score between 0 and 163 and a predicted mortality between 0% and 100%. Lower values are associated with lower mortality. | Median | Inter-Quartile Range | units on a scale |
|
| Septic shock on admission | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Mortality Within 90 Days From Randomization | 11 patients lost at the follow-up | Posted | Count of Participants | Participants | 90 days from randomization |
|
|
|
| Secondary | ICU LOS Reduction Measured as Days Not Spent in the ICU During the First 30 Days From Randomization | Posted | Mean | Standard Deviation | days | 30 days from randomization |
|
|
|
| Secondary | Septic Shock Resolution Measured as Number of Days Free of Vasoactive Drugs From Randomization | Not Posted | 15 days from randomization | Participants |
| 36 |
| 63 |
| 0 |
| 63 |
| 0 |
| 63 |
| EG001 | Control Group | standard practice | 25 | 52 | 0 | 52 | 0 | 52 |
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |