Shock, Septic
Conditions
Keywords
septic shock, intensive care medicine, coupled plasma filtration-adsorption
Brief 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).
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).
Interventions
DEVICEHigh 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.
Sponsors
Bellco Srl Mirandola, Italy
Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients admitted to the ICU in septic shock * All patients that develop septic shock while in the ICU
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Mortality | 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. |
Secondary
| Measure | 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 |
| Septic Shock Resolution Measured as Number of Days Free of Vasoactive Drugs From Randomization | 15 days from randomization |
Countries
Italy
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 63 |
| Control Group Standard practice | 52 |
| Total | 115 |
Baseline characteristics
| Characteristic | High Doses CPFA | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 39 Participants | 32 Participants | 71 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 20 Participants | 44 Participants |
| Age, Continuous | 66.9 years STANDARD_DEVIATION 13.8 | 67.0 years STANDARD_DEVIATION 10.5 | 67.0 years STANDARD_DEVIATION 12.4 |
| Length of stay before ICU admission | 4.0 days STANDARD_DEVIATION 7.2 | 3.0 days STANDARD_DEVIATION 5.2 | 3.6 days STANDARD_DEVIATION 6.4 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Italy | 63 participants | 52 participants | 115 participants |
| SAPS II | 60 units on a scale | 55 units on a scale | 57.5 units on a scale |
| Septic shock on admission | 45 Participants | 40 Participants | 85 Participants |
| Sex: Female, Male Female | 23 Participants | 24 Participants | 47 Participants |
| Sex: Female, Male Male | 40 Participants | 28 Participants | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 36 / 63 | 25 / 52 |
| other Total, other adverse events | 0 / 63 | 0 / 52 |
| serious Total, serious adverse events | 0 / 63 | 0 / 52 |
Outcome results
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.
Time frame: At the discharge from the latest hospital (on average 30.3 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Doses CPFA | Hospital Mortality | 35 Participants |
| Control | Hospital Mortality | 24 Participants |
Secondary
ICU LOS Reduction Measured as Days Not Spent in the ICU During the First 30 Days From Randomization
Time frame: 30 days from randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Doses CPFA | ICU LOS Reduction Measured as Days Not Spent in the ICU During the First 30 Days From Randomization | 6.6 days | Standard Deviation 9.7 |
| Control | ICU LOS Reduction Measured as Days Not Spent in the ICU During the First 30 Days From Randomization | 9.3 days | Standard Deviation 9.9 |
Secondary
Mortality Within 90 Days From Randomization
Time frame: 90 days from randomization
Population: 11 patients lost at the follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Doses CPFA | Mortality Within 90 Days From Randomization | 36 Participants |
| Control | Mortality Within 90 Days From Randomization | 25 Participants |
Secondary
Septic Shock Resolution Measured as Number of Days Free of Vasoactive Drugs From Randomization
Time frame: 15 days from randomization