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: 19.1Level: 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-ES
• Lead Sponsor: B. Braun Melsungen AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-21
• Last Update Posted: 28 May 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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 = 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 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 hypernatraemia,
Severe hyperchloraemia
Hyperkalaemia
Metabolic alkalosis
Severely impaired hepatic 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

Primary Outcome Measures

Name	Time	Method
Main Objective: Investigate the safety and efficacy of a 6% HES 130 versus an electrolyte solution in patients undergoing elective abdominal surgery;Secondary Objective: Further investigation of safety and efficacy of the applied products;Primary end point(s): Difference in mean estimated glomerular filtration rate (eGFR) between the two treatment groups, calculated from the highest Cystatin-C level measured during post-operative days (POD) 1-3.;Timepoint(s) of evaluation of this end point: Cystatin-C levels will be determined on POD 1-3. eGFR will be calculated from the highest Cystain-C level during this period.