Condition category
Urological and Genital Diseases
Date applied
17/03/2006
Date assigned
24/03/2006
Last edited
30/06/2009
Prospective/Retrospective
Retrospectively 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

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 measures

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

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

Sponsor information

Organisation

Gambro Dialysatoren GmbH (Germany)

Sponsor details

Holger-Crafoord-Str. 26
Hechingen
72379
Germany

Sponsor type

Industry

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes