Controlled, international study conducted in several centres on the safety and therapeutic effect of a Hydroxylethyl-starch (HES) solution versus an electrolyte solution in patients undergoing elective abdominal surgery

Phase 1

• Conditions: Hypovolaemia due to acute blood loss in elective abdominal surgery; MedDRA version: 20.0Level: PTClassification code 10021137Term: HypovolaemiaSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]

• Registration Number: EUCTR2016-002162-30-AT
• Lead Sponsor: Fresenius Kabi Deutschland GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-09
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 2280

Inclusion Criteria

The following inclusion criteria apply:
•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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 780

Exclusion Criteria

Patients will not be considered for participation in the study if any of the following criteria listed below apply:
•Hypersensitivity to the active substances or to any of the other excipients of the IPs
•Body weight = 140 kg
•Sepsis
•Burns
•Renal impairment (defined as 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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified