Condition category
Infections and Infestations
Date applied
31/05/2006
Date assigned
11/07/2006
Last edited
10/01/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.giviti.marionegri.it

Contact information

Type

Scientific

Primary contact

Dr Sergio Livigni

ORCID ID

Contact details

Servizio Anestesia e Rianimazione B-DEA
Ospedale San Giovanni Bosco
Piazza del Donatore di Sangue 3
Torino
10148
Italy
+39 (0)11 240 2265
sergio.livigni@aslto4.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00332371

Protocol/serial number

4817

Study information

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

Acronym

COMPACT

Study hypothesis

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

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

Study design

Open-label randomised controlled multi-centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Patient information can be found at: http://www.giviti.marionegri.it/Download/SchedaInformativaCOMPACT[IT].zip

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

15/06/2006

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

All patients admitted to the ICU in septic shock or that develop septic shock while in the ICU

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

330

Participant 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

Recruitment start date

15/06/2006

Recruitment end date

31/12/2010

Locations

Countries of recruitment

Italy

Trial participating centre

Servizio Anestesia e Rianimazione B-DEA
Torino
10148
Italy

Sponsor information

Organisation

Italian Group for the Evaluation of Interventions in Intensive Care Medicine (GiViTI)

Sponsor details

Laboratorio di Epidemiologia Clinica
Istituto di Ricerche Farmacologiche
Mario Negri
Villa Camozzi
Via Camozzi 3
Ranica (BG)
24020
Italy
+39 (0)35 453 5313
giviti@marionegri.it

Sponsor type

Research organisation

Website

http://www.giviti.marionegri.it

Funders

Funder type

Research organisation

Funder name

Mario Negri Institute for Pharmacological Research (Italy) (ref: 4817)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

BELLCO s.r.l (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24401721

Publication citations

  1. Results

    Livigni S, Bertolini G, Rossi C, Ferrari F, Giardino M, Pozzato M, Remuzzi G, , Efficacy of coupled plasma filtration adsorption (CPFA) in patients with septic shock: A multicenter randomised controlled clinical trial., BMJ Open, 2014, 4, 1, e003536, doi: 10.1136/bmjopen-2013-003536.

Additional files

Editorial Notes