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 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77656437 |
| ClinicalTrials.gov number | NCT00875888 |
| Secondary identifying numbers | 0000050 |
- Submission date
- 17/03/2006
- Registration date
- 24/03/2006
- Last edited
- 31/12/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
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
Contact information
Dr Stanislao Morgera
Scientific
Scientific
Medizinische Klinik mit Schwerpunkt Nephrologie
Charite, Campus Mitte
Schumannstr. 20/21
Berlin
10117
Germany
| Phone | +49 (0)304 5061 4137 |
|---|---|
| stanislao.morgera@charite.de |
Study information
| Study design | Double blind randomised prospective controlled multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific 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 |
| Study acronym | HICOSS |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 04/02/2004 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 120 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 04/02/2004 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- Austria
- Germany
Study participating centre
Medizinische Klinik mit Schwerpunkt Nephrologie
Berlin
10117
Germany
10117
Germany
Sponsor information
Gambro Dialysatoren GmbH (Germany)
Industry
Industry
Holger-Crafoord-Str. 26
Hechingen
72379
Germany
"ROR" |
https://ror.org/05jgtkc28 |
|---|
Funders
Funder type
Industry
Gambro Corporate Research (Germany)
No information available
Results and Publications
| 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 | 2009 results presented at WFSICCM 2009 https://scholar.google.com/scholar?q=Honore%20PM%2C%20Clark%20W.%20Novel%20therapeutical%20concepts%20for%20extracorporeal%20treatment%20of%20hyperinflammation%20and%20sepsis%3A%20immunomodulation.%20approach%20with%20a%20novel%20high%20Cut-OFF%20membrane%3A%20the%20SepteX%20membrane.%20In%20Proceedings%20of%2010th%20Congress%20of%20World%20Federation%20of%20CCU%20%28WFSICCM%29%202009.%20Florence. |
| IPD sharing plan | Not provided at time of registration |
Editorial Notes
31/12/2021: This study has been reported to have been prematurely terminated. Please see https://pubmed.ncbi.nlm.nih.gov/22179226/.
11/04/2019: The publication and dissemination plan was updated.
