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

Fresenius Kabi

Status and phase

Completed

Phase 4

Conditions

Hypovolaemia Due to Acute Blood Loss

Treatments

Drug: Ionolyte

Drug: Volulyte 6%

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03278548

HC-G-H-1504

HE06-024-CP4 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

2,289 patients

Sex

All

Ages

41 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)