A Multicenter, Non-interventional, Observational, Post-Approval Safety Study of Updated ACCUSOL 35 Solutions in Continuous Renal Replacement Therapy (ACCUPASS)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Non-interventional, observational risk assessment

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (B05ZB) Hemofiltrates

  Hemofiltrates

Population studied

• Short description of the study population:
  Male and non-pregnant female patients were eligible for enrollment if they were at least 18 years of age and have been undergoing continuous renal replacement therapy (CCRT) using ACCUSOL 35 solution(s), without any concomitant medication added to the solution (except for supplemental KCl, if required), with the same CRRT circuit for at least 40 hours from Austria, Belgium, Czech Republic, Denmark, France, Germany, Ireland, Netherlands, Spain, Sweden and United Kingdom.
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Renal impaired
• Estimated number of subjects:
  240

Study design details

• Main study objective:
  The objective of this study is to confirm the prevention of calcium carbonate precipitate formation during CRRT by the use of the updated ACCUSOL 35 solutions under normal clinical use conditions.
• Outcomes:
  Presence or absence of visible precipitate in the CRRT lines used during the study
• Data analysis plan:
  The primary analysis will be to generate the upper bound of the 95% confidence interval on the true proportion of treatments having precipitate formation, based on the data from the evaluable treatments.