Influence of exocrine pancreatic insufficiency on the formation of uremic toxin indoxyl sulfate in patients in a dialysis program

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Exocrine pancreatic function test
• Additional medical condition(s):
  The study involved anuric patients undergoing chronic renal replacement therapy. The study focused primarily on the relations between serum indoxyl sulfate concentration and pancreatic exocrine function. This was tested by using a non-invasive breath test.

Population studied

• 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:
  27

Study design details

• Main study objective:
  The aim of this tudy was to test anuric patients by using a non-invasive breath test with 13C mixed triglyceride for subclinical pancreatic insufficiency.
• Data analysis plan:
  All statistical analyses were performed using the SigmaStat software version 3.1 (Systat Software Inc. US). The obtained data are presented as median (interquartile range) or as mean ± standard deviation. The statistical difference between the groups was tested using a Mann-Whitney rank-sum test and p ≤ 0.05 was considered statistically significant. The correlation of the parameters was tested using Pearson's correlation coefficient.