COMbining Plasmafiltration and Adsorption Clinical Trial: efficacy and safety of coupled plasma filtration adsorption for septic shock in the intensive care unit
| ISRCTN | ISRCTN24534559 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24534559 |
| ClinicalTrials.gov number | NCT00332371 |
| Secondary identifying numbers | 4817 |
- Submission date
- 31/05/2006
- Registration date
- 11/07/2006
- Last edited
- 10/01/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Sergio Livigni
Scientific
Scientific
Servizio Anestesia e Rianimazione B-DEA
Ospedale San Giovanni Bosco
Piazza del Donatore di Sangue 3
Torino
10148
Italy
| Phone | +39 (0)11 240 2265 |
|---|---|
| sergio.livigni@aslto4.it |
Study information
| Study design | Open-label randomised controlled multi-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Patient information can be found at: http://www.giviti.marionegri.it/Download/SchedaInformativaCOMPACT[IT].zip |
| Scientific title | COMbining Plasmafiltration and Adsorption Clinical Trial: efficacy and safety of coupled plasma filtration adsorption for septic shock in the intensive care unit - an open-label randomised controlled multi-centre trial |
| Study acronym | COMPACT |
| Study objectives | To clarify whether the application of coupled plasma filtration adsorption (CPFA) in addition to the current clinical practice is able to reduce mortality of septic shock patients in intensive care unit (ICU). Please note that extensive amendments have been made to this trial record as of 24/04/2009. They include the following: 1. The scientific title has been added 2. The anticipated end date has been updated from 30/09/2008 to 31/12/2010 All other amendments are recorded in the relevant fields. |
| Ethics approval(s) | Approval received from the Ethical Committee for Local Business Health, Piemonte Region (Comitato Etico Azienda Sanitaria Locale 4 Regione Piemonte) as of 27/06/2006, reference number: 229/10/06 |
| Health condition(s) or problem(s) studied | Septic shock |
| Intervention | Coupled plasma filtration adsorption (CPFA) versus standard clinical practice. Added as of 24/04/2009: The intervention lasts 10 hours/day for a total of 5 days of treatment. The follow-up ends on the date of discharge from the last hospital or after 90 days from randomisation in patients discharged after 90 days. |
| Intervention type | Other |
| Primary outcome measure | Hospital mortality Added as of 24/04/2009: Total duration of follow-up: until 90 days after the randomisation of the last patients recruited. |
| Secondary outcome measures | 1. Mortality within 90 days from randomisation 2. New organ failures, assessed by Sequential Organ Failure Assessment (SOFA) score during the ICU stay 3. Days not spent in the ICU during the first 30 days from randomisation Please note that the method and timepoint of assessment for the outcome measure "New organ failures" were added as of 24/04/2009. |
| Overall study start date | 15/06/2006 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 330 |
| Key inclusion criteria | All patients admitted to the ICU in septic shock or that develop septic shock while in the ICU |
| Key exclusion criteria | Patients with any of the following characteristics:: 1. Age less than 18 years 2. Pregnancy 3. Cardiopulmonary resuscitation 4. Cerebral coma (Glasgow coma score [GCS] <8 due to organic cerebral diseases, irrespective of their surgical, non-surgical, or trauma origin) 5. Metastatic cancer 6. Presence of relative or absolute contraindications to CPFA 7. Estimated life expectancy less than two weeks 8. Already included in the study 9. Admission from another ICU where the patient has been admitted for more than 24 hours 10. Absence of informed consent |
| Date of first enrolment | 15/06/2006 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- Italy
Study participating centre
Servizio Anestesia e Rianimazione B-DEA
Torino
10148
Italy
10148
Italy
Sponsor information
Italian Group for the Evaluation of Interventions in Intensive Care Medicine (GiViTI)
Research organisation
Research organisation
Laboratorio di Epidemiologia Clinica
Istituto di Ricerche Farmacologiche
Mario Negri
Villa Camozzi
Via Camozzi 3
Ranica (BG)
24020
Italy
| Phone | +39 (0)35 453 5313 |
|---|---|
| giviti@marionegri.it | |
| Website | http://www.giviti.marionegri.it |
Funders
Funder type
Research organisation
Mario Negri Institute for Pharmacological Research (Italy) (ref: 4817)
No information available
BELLCO s.r.l (Italy)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 08/01/2014 | Yes | No |
