Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1485
Study information
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
Acronym
Study hypothesis
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
Ethics approval pending as of 28/10/2010
Study design
Prospective open label randomised active controlled crossover study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
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
Phase
Phase IV
Drug names
Primary outcome measures
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 trial start date
17/01/2011
Overall trial end date
27/05/2011
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
24
Participant 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
Recruitment start date
17/01/2011
Recruitment end date
27/05/2011
Locations
Countries of recruitment
Sweden
Trial participating centre
Magistratsvägen 16
Lund
SE-22010
Sweden
Sponsor information
Organisation
Gambro Lundia AB (Sweden)
Sponsor details
Magistratsvägen 16
P.O.Box 10101
Lund
SE-22010
Sweden
kristina.hansson@gambro.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Gambro (Sweden)
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
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24103587
Publication citations
-
Results
Grundström G, Christensson A, Alquist M, Nilsson LG, Segelmark M, Replacement of acetate with citrate in dialysis fluid: a randomized clinical trial of short term safety and fluid biocompatibility., BMC Nephrol, 2013, 14, 216, doi: 10.1186/1471-2369-14-216.