Comparison of acetic-free versus conventional dialysis fluid in patients with chronic renal failure
| ISRCTN | ISRCTN28536511 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28536511 |
| Secondary identifying numbers | 1485 |
- Submission date
- 28/10/2010
- Registration date
- 09/08/2011
- Last edited
- 25/10/2013
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Kristina Hansson
Scientific
Scientific
Magistratsvägen 16
Lund
SE-22010
Sweden
Study information
| Study design | Prospective open label randomised active controlled crossover study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | Biocompatibility of a new acetic free dialysis fluid (Honeycit) compared to conventional dialysis fluid (Selectbag® One) in an open, randomised, prospective, controlled crossover study |
| Study objectives | A new dialysis fluid containing citric acid has been developed. The safety and biocompatibility of citrate containing dialysate has earlier been investigated with positive results. The aim of this study is to verify the biocompatibility during 6 weeks use of the study product. |
| Ethics approval(s) | Ethics approval pending as of 28/10/2010 |
| Health condition(s) or problem(s) studied | Chronic renal failure |
| Intervention | Patients will be randomised to receive dialysis with either 1. New acetic free dialysis fluid (Honeycit) 2. Conventional dialysis fluid (Selectbag® One) Patients in each group will receive 6 weeks of treatment, followed by a 2 week wash out period, then crossover to the alternative treatment for a further 6 weeks. |
| Intervention type | Other |
| Primary outcome measure | Plasma concentration (P) of Advanced Glycation End products (AGEs), analysed by fluorescence (em 430/ex 350), pre- and post- each 6 week treatment phase |
| Secondary outcome measures | 1. Safety: 1.1. Adverse effects (AE) / Severe adverse effects (SAE) 1.2. Plasma (P)-Parathyroid hormone (PTH) 1.3. P-Ionized-calcium 1.4. P-Citrate 1.5. Blood gas (pH, PO2, PCO2, Base excess) 1.6. Blood (B)-Complete Blood Count (Haemoglobin [Hb], Haematocrit [Hct], White Blood Count [WBC], Red Blood Count [RBC] and Platelets) 1.7. P-Electrolytes (sodium [Na], potassium [K], total calcium [tot-Ca], chlorine [Cl], urea and albumin) 1.8. Blood pressure and heart rate 2. Inflammation: 2.1. P- C-reactive Protein (CRP) 2.2. B- Interleukin (IL)-6 2.3. B- IL-1β 2.4. B- Tumour Necrosis Factor (TNF)-α 3. Coagulation: 3.1. B- Thrombin-Antithrombin (TAT) 3.2. B- Activated Partial Thromboplastin Time (APTT) 3.3. Visual rinse-back information and assessment 4. Additional exploratory parameters: 4.1. Biocompatibility: 4.1.1. Carboxymethyllysine (CML) 4.1.2. Pentosidine 4.1.3. Pentraxin-related protein (PTX3) 4.1.4. Glutathione (GSH/GSSG) 4.1.5. Malondialdehyde (MDA) 4.1.6. 8-Oxo-2'-deoxyguanosine (8-oxo-dG) 4.1.7. modified Advanced Oxidation Protein Product (mAOPP) (stress biomarker) 4.1.8 Total Aminothiols 4.2. Treatment parameters: 4.2.1. Treatment mode (HD/HDF) 4.2.2. Dialyser 4.2.3. Blood circuit and machine 4.2.4. Body weight before and after treatment 4.2.5. Treatment time 4.2.6. Blood flow rate 4.2.7. Dialysis flow rate 4.2.8. Ultra filtration rate and volume 4.2.9. Trans-Membrane Pressure (TMP) 4.2.10. Arterial and venous pressure 4.2.11. Accumulated blood volume and where applicable total infusion volume 4.2.12. Anticoagulation (type, dosage and administration) and potassium level. Diascan Kt/V All outcomes will be assessed pre- and post- each 6 week treatment phase. |
| Overall study start date | 17/01/2011 |
| Completion date | 27/05/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 24 |
| Key inclusion criteria | 1. Chronic renal failure 2. Stable patients treated on Gambro Select® system (AK200S or AK200 Ultra S) 3 times/week for at least 4 weeks using SelectBag® One (Ca+1.5 mmol/l) 3. Patients treated in haemodialysis (HD) or Haemodiafiltration (HDF) mode with a blood flow rate between 250-400 ml/min during 4-5.5 hours 4. Patients treated with Gambro high flux filter; Polyflux 170H or Polyflux 210H 5. Signed consent to participate in the study (informed consent) 6. Patient aged 18 years or older, male or female 7. Haemoglobin 10 to 13.5 g/dl (haematocrit 30% to 40%) 8. Patients able to tolerate prescribed dialysis fluid with electrolyte concentrations as specified for the test device 9. Technical survival during study period as judged by study investigator |
| Key exclusion criteria | 1. Known Human Immunodeficiency Virus (HIV), Hepatitis C or B Virus (HCV or HBV) infection (positive serology) 2. Patients with ionized-calcium value < 1.1 mmol/l 3. Patients unable to tolerate Citrate as judged by Investigator 4. Patients using Citrate anticoagulation in usual HD treatment 5. Pregnant / planning pregnancy and lactating women during study period 6. Patients with acute inflammatory or infectious event which, as judge by Investigator, may affect the safety of the patient and/or the result of the study 7. Patients with known haemodynamic instability that, as judged by the investigator, might cause clinical treatment problems 8. Chronic single needle dialysis 9. Participation in other studies during the study period that can affect the outcome of this study 10. Patients not considered compliant in following the study protocol, as judged by Investigator |
| Date of first enrolment | 17/01/2011 |
| Date of final enrolment | 27/05/2011 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Magistratsvägen 16
Lund
SE-22010
Sweden
SE-22010
Sweden
Sponsor information
Gambro Lundia AB (Sweden)
Industry
Industry
Magistratsvägen 16
P.O.Box 10101
Lund
SE-22010
Sweden
| kristina.hansson@gambro.com | |
"ROR" |
https://ror.org/05mw5ed57 |
Funders
Funder type
Industry
Gambro (Sweden)
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 | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 09/10/2013 | Yes | No |
