Last updated on July 2019

Safety and Efficacy of 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Patients Undergoing Elective Abdominal Surgery

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Hypovolaemia Due to Acute Blood Loss
  • Age: Between 41 - 85 Years
  • Gender: Male or Female

Inclusion: Male or female adult patients > 40 and 85 years of age. Women of child bearing potential must test negative on standard pregnancy test (urine or serum)

  • Patients undergoing elective abdominal surgery with an expected blood loss of 500 ml
  • ASA Physical Status II - III
  • Signed written informed consent form

Exclusion: Hypersensitivity to the active substances or to any of the other excipients of the investigational medicinal products

  • Body weight 140 kg
  • Sepsis
  • Burns
  • Renal impairment (AKIN stage 1) or acute and/or chronic renal replacement therapy
  • Intracranial or cerebral haemorrhage
  • Critically ill patients (typically admitted to the intensive care unit)
  • Hyperhydration
  • Pulmonary oedema
  • Dehydration
  • Hyperkalaemia
  • Severe hypernatraemia
  • Severe hyperchloraemia
  • Severely impaired hepatic function
  • Congestive heart failure
  • Severe coagulopathy
  • Organ transplant patients
  • Metabolic alkalosis
  • Simultaneous participation in another interventional clinical trial (drugs or medical devices studies)

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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