Hydroxyethyl starch (HES) solutions and risk of acute kidney injury and mortality in acute trauma patients

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Systematic review and meta-analysis

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  HYDROXYETHYL STARCH 130/0.4
• Medical condition to be studied:
  Death

  Acute kidney injury

Population studied

• Short description of the study population:
  Acute trauma patients who had received hydroxyethyl starch (HES) solutions.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Acute trauma patients
• Estimated number of subjects:
  0

Study design details

• Main study objective:
  A systematic review, to update the existing evidence regarding HES association with acute kidney injury and mortality in acute trauma patients.
• Outcomes:
  Acute kidney injuryAll-cause mortality
• Data analysis plan:
  A systematic review of literature was performed. Searches in PubMed and Embase were conducted, for English language articles, studies conducted in humans, published between 01/08/2013 and 22/11/2017. The following exclusion criteria were applied: - preclinical studies - case studies or case series- reviews, commentaries or opinion letters - clinical guidances, opinion papers, recommendationsData collection in individual studies was required to go beyond 2013 and for meta-analysis - to include studies finalized after October 2013.The studies were reviewed only at abstract level.