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

Fresenius Kabi2,289 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

2,289

Conditions

Hypovolaemia Due to Acute Blood Loss

Interventions

Volulyte 6%DRUG

Solution for infusion

IonolyteDRUG

Solution for infusion

Eligibility

Sex: ALLMin age: 41 YearsMax age: 85 Years

Medical Language ↔ Plain English

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)

Locations (61)

Outcomes

Primary Outcomes

Difference in mean estimated glomerular filtration rate (eGFR) (calculated from highest cystatin-C levels measured during post-operative days 1-3 (POD 1-3)) between the two treatment groups

Time frame: post-operative days 1-3

Secondary Outcomes

Renal function

Time frame: until 1 year after surgery

Calculated red blood cell (RBC) loss

Time frame: on post-operative day 3

Estimated intra-operative blood loss

Time frame: end of surgery

Coagulation

Time frame: until post-operative day 1

Inflammation

Time frame: until post-operative day 1

Adverse events

Time frame: until post-operative day 90

Major post-operative complications

Time frame: until post-operative day 90

Mortality

Time frame: 1 year

Composite of mortality and major post-operative complications (including renal)

Time frame: until post-operative day 90

Total volume of administered investigational product

Time frame: until 24 hours after investigational product treatment start

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

General Hospital of Barmherzige Brüder

Sankt Veit, Austria

Social Medical Center East - Donauspital

Vienna, Austria

Cliniques Universitaires Saint Luc

Brussels, Belgium

AZ Maria Middelares

Ghent, Belgium

Jessa Ziekenhuis

Hasselt, Belgium

Clinical Hospital Sveti Duh

Zagreb, Croatia

University Hospital Sisters of Mercy

Zagreb, Croatia

University Hospital Zagreb

Zagreb, Croatia

Kolín Hospital

Kolín, Czechia

Central Military Hospital Prague

Prague, Czechia

...and 51 more locations

Fluid balance [Sum of volume of all intravenous medication (including investigational product and blood products) minus sum of volume of urine output (if available), drainage and estimated intra-operative blood loss]

Time frame: until post-operative day 3

Heart Rate

Time frame: until post-operative day 3

Body temperature

Time frame: until post-operative day 3

Mean arterial pressure

Time frame: until post-operative day 3, if available

Systolic arterial blood pressure