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-BE
• Lead Sponsor: Fresenius Kabi Deutschland GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-30
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2280

Inclusion Criteria

Male or female adult patients > 40 and <= 85 years of age
Women of childbearing potential must test negative on standard pregnancy test (urine or serum)
Patients undergoing elective abdominal surgery with an expected blood loss of at least 500 ml
ASA Physical Status II-III
Signed written 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

Hypersensitivity to the active substances or to any of the other excipients of the investigational 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)
Dehydration
Hyperhydration
Pulmonary oedema
Congestive heart failure
Severe hypernatremia
Severe Hyperchloraemia
Hyperkalemia
Metabolic alkalosis
Severely impaired liver function
Severe coagulopathy
Organ transplant patients
Simultaneous participation in another interventional trial (drugs or medical device)

Study & Design

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