Comparison of acetic-free versus conventional dialysis fluid in patients with chronic renal failure

ISRCTN	ISRCTN28536511
DOI	https://doi.org/10.1186/ISRCTN28536511
Protocol serial number	1485
Sponsor	Gambro Lundia AB (Sweden)
Funder	Gambro (Sweden)

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

Magistratsvägen 16
Lund
SE-22010
Sweden

Study information

Primary study design	Interventional
Study design	Prospective open label randomised active controlled crossover study
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	Plasma concentration (P) of Advanced Glycation End products (AGEs), analysed by fluorescence (em 430/ex 350), pre- and post- each 6 week treatment phase
Key secondary outcome measure(s)	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.
Completion date	27/05/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes