Contact information
Type
Scientific
Primary contact
Dr Stanislao Morgera
ORCID ID
Contact details
Medizinische Klinik mit Schwerpunkt Nephrologie
Charite
Campus Mitte
Schumannstr. 20/21
Berlin
10117
Germany
+49 (0)304 5061 4137
stanislao.morgera@charite.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00875888
Protocol/serial number
0000050
Study information
Scientific title
Acronym
HICOSS
Study hypothesis
The aim of the study is to evaluate whether high cut-off continuous venovenous haemodialysis (CVVHD) leads to a significant improvement of the haemodynamic status in comparison to CVVHD treatment with conventional high-flux filters.
Ethics approval
Approved by the following ethics committees:
1. Campus Charite Mitte, Berlin (ref: 1988/Si. 277) on 11/09/2003
2. University Clinic Tubingen (ref: 249/2003G) on 08/04/2004
3. Medical University Innsbruck (ref: 231/4.11) on 07/07/2005
4. Ethics Committee for Medical Research, Philipps-University Marburg clinic (ref: 19/06) on 15/02/2006
Study design
Double blind randomised prospective controlled multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Acute renal failure after SIRS/septic shock
Intervention
Continuous venovenous haemodialysis treatment with high-flux or high-cut-off dialysers.
Please note that as of 13/12/2007 the anticipated end date of this trial was extended to 31/12/2008 due to the enrolment period being extended. The previous anticipated end date of this trial was 31/12/2006.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Dosage of vasopressors
2. Mean arterial pressure
3. Heart rate
4. Central venous pressure
Secondary outcome measures
1. Sequential Organ Failure Assessment (SOFA) score
2. Survival at 28 days
3. Length of need for catecholamine application
4. Length of need for mechanical ventilation
5. Length of need for renal replacement therapy
6. Length of stay in intensive care unit (ICU)
Overall trial start date
04/02/2004
Overall trial end date
31/12/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Fulfilling at least two of the SIRS criteria as defined by the American College of Chest Physicians (ACCP)/Society of Critical Care Medicine (SCCM) Consensus Conference
2. Having signs of renal dysfunction
3. Requirement for catecholamine administration (norepinephrine or others)
4. Acute Physiology And Chronic Health Evaluation (APACHE II) score at enrolment greater than or equal to 19 and less than or equal to 30
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120
Participant exclusion criteria
1. Lack of written informed consent from patients or a legally authorized surrogate
2. Duration of septic shock greater than 4 days
3. Hypoproteinaemia (characterized by serum albumin less than 18 g/l)
4. End stage renal failure
5. Known active malignancy
6. Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
7. Age younger than 18 years or older than 80 years
8. Known pregnancy
9. Immunosuppression after transplantation
10. Participation in another clinical study
11. Renal replacement therapy greater than 24 hours before randomisation
Recruitment start date
04/02/2004
Recruitment end date
31/12/2008
Locations
Countries of recruitment
Austria, Germany
Trial participating centre
Medizinische Klinik mit Schwerpunkt Nephrologie
Berlin
10117
Germany
Funders
Funder type
Industry
Funder name
Gambro Corporate Research (Germany)
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
Basic results (scientific)
Publication list