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| [ Print-friendly version ] |
| High cut-off Continuous venovenous haemodialysis (CVVHD) to improve haemodynamic stability and Organ function scores in patients treated for acute renal failure after Systemic inflammatory response Syndrome (SIRS)/septic shock |
| ISRCTN | ISRCTN77656437 |
| ClinicalTrials.gov identifier | NCT00875888 |
| Public title | High cut-off Continuous venovenous haemodialysis (CVVHD) to improve haemodynamic stability and Organ function scores in patients treated for acute renal failure after Systemic inflammatory response Syndrome (SIRS)/septic shock |
| Scientific title | |
| Acronym | HICOSS |
| Serial number at source | 0000050 |
| 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. |
| Lay summary | |
| 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 |
| Countries of recruitment | Austria, Germany |
| Disease/condition/study domain | Acute renal failure after SIRS/septic shock |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 04/02/2004 |
| Anticipated end date | 31/12/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 120 |
| Interventions |
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. |
| Primary outcome measure(s) |
1. Dosage of vasopressors
2. Mean arterial pressure 3. Heart rate 4. Central venous pressure |
| Secondary outcome measure(s) |
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) |
| Sources of funding | Gambro Corporate Research (Germany) |
| Trial website | |
| Publications | |
| Contact name | Dr Stanislao Morgera |
| Address |
Medizinische Klinik mit Schwerpunkt Nephrologie
Charite, Campus Mitte Schumannstr. 20/21 |
| City/town | Berlin |
| Zip/Postcode | 10117 |
| Country | Germany |
| Tel | +49 (0)304 5061 4137 |
| Fax | +49 (0)304 5051 4902 |
| stanislao.morgera@charite.de | |
| Sponsor | Gambro Dialysatoren GmbH (Germany) |
| Address | Holger-Crafoord-Str. 26 |
| City/town | Hechingen |
| Zip/Postcode | 72379 |
| Country | Germany |
| Date applied | 17/03/2006 |
| Last edited | 30/06/2009 |
| Date ISRCTN assigned | 24/03/2006 |
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