Evaluation of hemodynamic effects of cascade hemofiltration in septic shock

ISRCTN	ISRCTN20442117
DOI	https://doi.org/10.1186/ISRCTN20442117
Secondary identifying numbers	1450

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Mrs Nathalie Loughraieb
Scientific

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

Study design	Multi-center, pilot, prospective, parallel-group, randomised controlled study.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	Evaluation of the hemodynamic improvement using cascade hemofiltration in patients treated for septic shock
Ethics approval(s)	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
Health condition(s) or problem(s) studied	Septic shock/ hemofiltration
Intervention	Either standard hemofiltration or Cascade hemofiltration (2 types of membrane evaluated)
Intervention type	Other
Primary outcome measure	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 study start date	01/03/2008
Completion date	01/03/2011

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	60
Key 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
Key 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)
Date of first enrolment	01/03/2008
Date of final enrolment	01/03/2011

Gambro Industries

Lyon
69357
France

Gambro Industries, Clinical Affairs Department (France)
Industry

61 Avenue Tony Garnier
BP 7315
Lyon
69357
France

"ROR"	https://ror.org/01mgtdr23

Industry

Gambro Industries (International)

No information available

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