Condition category
Infections and Infestations
Date applied
09/01/2008
Date assigned
01/02/2008
Last edited
28/02/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Nathalie Loughraieb

ORCID ID

Contact details

Gambro Industries
Clinical Affairs Department
61 Avenue Tony Garnier
BP 7315
Lyon
69357
France

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1450

Study information

Scientific title

Acronym

Study hypothesis

Evaluation of the hemodynamic improvement using cascade hemofiltration in patients treated for septic shock

Ethics approval

1. Committee for Protection of Research Subjects (Comité de Protection des Personnes [CPP]) Ile de France VI, approved on 16 July 2007
2. France's Sanitary Safety in Health Products Agency (AFSSAPS), approved on 30 October 2007

Study design

Multi-center, pilot, prospective, parallel-group, randomised controlled study.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Septic shock/ hemofiltration

Intervention

Either standard hemofiltration or Cascade hemofiltration (2 types of membrane evaluated)

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Number of days without catecholamines at the 28th day of randomization

Secondary outcome measures

1. Rate of decrease of catecholamines during the first 72h
2. Number of days without mechanical ventilation at the 90th day
3. Number of days without Renal Replacement Therapy (RRT) at the 90th day
4. Number of days without ICU requirement at the 90th day
5. Death or survivor status at the 90th day

Overall trial start date

01/03/2008

Overall trial end date

01/03/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patient with a septic shock diagnosed by the medical staff team
2. Patient mechanically ventilated and treated by high doses of catecholamines after adequate fluid administration (superior or equal to 1.0 mg/h of norepinephrine or epinephrine) for more than 120 minutes and <24h
Note: Patients with renal failure (treated or not) can be included

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

60

Participant exclusion criteria

1. Age (years) <18 or >85
2. Weight >120 kg
3. Thrombocytopenia 50< G/l or Neutrophils <0.5 Giga/l
4. Contra indication to heparin anticoagulation
5. Patient requiring catecholamines (epinephrine or norepinephrine superior or equal to 1 mg/h) for >24h
6. Patient admitted to the Intensive Care Unit (ICU) superior or equal to 7 days before the inclusion criteria
7. Patient with intercurrent disease limiting his/her self-sufficiency (need of help before septic shock)
8. Inclusion (<28 days) in another study interfering with the goals of the current investigation
9. Pregnancy and patient under guardianship
10. Immune compromised patients (e.g., being treated for cancer, treated by immunosuppressors or steroids, AIDS)

Recruitment start date

01/03/2008

Recruitment end date

01/03/2011

Locations

Countries of recruitment

France

Trial participating centre

Gambro Industries
Lyon
69357
France

Sponsor information

Organisation

Gambro Industries, Clinical Affairs Department (France)

Sponsor details

61 Avenue Tony Garnier
BP 7315
Lyon
69357
France

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Gambro Industries (International)

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

Publication citations

Additional files

Editorial Notes