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

• Status: Recruiting
• Trial end date: 2020-06-17
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to investigate the safety of a 6% HES (Hydroxyethyl Starch) solution (Volulyte 6%) versus an electrolyte solution (Ionolyte) in patients undergoing elective abdominal surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: B. Braun Melsungen AG
• Collaborators: European Society of Anaesthesiology; Fresenius Kabi
• Treatments: Hydroxyethyl Starch Derivatives; Pharmaceutical Solutions

Criteria

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 chronic) 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)