Prospective, Randomized, Controlled, Double-blind, Multi-centre, Multinational Study on the Safety and Efficacy of 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Patients Undergoing Elective Abdominal Surgery

HC-G-H-1504

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.

2017-09-28

2022-04-09

2022-07-06

Completed

Early phase I

2289

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)

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2024-01-31