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 (NCT)	NCT00332371
Protocol serial number	4817
Sponsor	Italian Group for the Evaluation of Interventions in Intensive Care Medicine (GiViTI)
Funders	Mario Negri Institute for Pharmacological Research (Italy) (ref: 4817), BELLCO s.r.l (Italy)

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

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
Email	sergio.livigni@aslto4.it

Study information

Primary study design	Interventional
Study design	Open-label randomised controlled multi-centre trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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(s)	Hospital mortality Added as of 24/04/2009: Total duration of follow-up: until 90 days after the randomisation of the last patients recruited.
Key secondary outcome measure(s)	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.
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes