Status:
COMPLETED
Safety and Efficacy of 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Patients Undergoing Elective Abdominal Surgery
Lead Sponsor:
Fresenius Kabi
Collaborating Sponsors:
B. Braun Melsungen AG
European Society of Anaesthesiology and Intensive Care
Conditions:
Hypovolaemia Due to Acute Blood Loss
Eligibility:
All Genders
41-85 years
Phase:
PHASE4
Brief 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.
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
September 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 6 2022
Estimated Enrollment :
2289 Patients enrolled
Trial Details
Trial ID
NCT03278548
Start Date
September 28 2017
End Date
July 6 2022
Last Update
January 31 2024
Active Locations (61)
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1
General Hospital of Barmherzige Brüder
Sankt Veit, Austria
2
Social Medical Center East - Donauspital
Vienna, Austria
3
Cliniques Universitaires Saint Luc
Brussels, Belgium
4
AZ Maria Middelares
Ghent, Belgium