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

Study Overview
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Brief Summary
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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.

Official Title
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Prospective, Randomized, Controlled, Double-blind, Multi-centre, Multinational Study on the Safety and Efficacy of 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Patients Undergoing Elective Abdominal Surgery

Conditions
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Hypovolaemia Due to Acute Blood Loss

Intervention / Treatment
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* Drug: Volulyte 6%
* Drug: Ionolyte


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 41 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Volulyte 6%<br>Volulyte 6% solution for infusion | Drug: Volulyte 6%<br>* Solution for infusion<br>* Other names: Hydroxyethyl starch 130/0.4;|
| Active Comparator: Ionolyte<br>Ionolyte solution for infusion | Drug: Ionolyte<br>* Solution for infusion<br>* Other names: Electrolyte solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | post-operative days 1-3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function |  | until 1 year after surgery | 
| Calculated red blood cell (RBC) loss |  | on post-operative day 3 | 
| Estimated intra-operative blood loss |  | end of surgery | 
| Coagulation |  | until post-operative day 1 | 
| Inflammation |  | until post-operative day 1 | 
| Adverse events |  | until post-operative day 90 | 
| Major post-operative complications |  | until post-operative day 90 | 
| Mortality |  | 1 year | 
| Composite of mortality and major post-operative complications (including renal) |  | until post-operative day 90 | 
| Total volume of administered investigational product |  | until 24 hours after investigational product treatment start | 
| 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] |  | until post-operative day 3 | 
| Heart Rate |  | until post-operative day 3 | 
| Body temperature |  | until post-operative day 3 | 
| Mean arterial pressure |  | until post-operative day 3, if available | 
| Systolic arterial blood pressure |  | until end of surgery | 
| Diastolic arterial blood pressure |  | until end of surgery | 
| Central venous pressure (if available) |  | until end of surgery | 
| Haemodynamics readings as required to determine volume responsiveness [at least one parameter (stroke volume, stroke volume variation, stroke volume index, pulse pressure variation, mean arterial pressure) has to be used to guide volume administration] |  | until 24 hours after investigational product treatment start | 
| Partial pressure of carbon dioxide |  | until end of surgery | 
| Partial pressure of oxygen |  | until end of surgery | 
| Bicarbonate |  | until end of surgery | 
| Arterial oxygen saturation |  | until end of surgery | 
| Haemoglobin |  | until post-operative day 3 | 
| Haematocrit |  | until post-operative day 3 | 
| pH |  | until end of surgery | 
| Base Excess |  | until end of surgery | 
| Lactate |  | until post-operative day 3 | 
| Central venous oxygen saturation (if available) |  | until post-operative day 1 | 
| Serum sodium |  | until post-operative day 1 | 
| Serum potassium |  | until post-operative day 1 | 
| Serum calcium |  | until post-operative day 1 | 
| Serum chloride |  | until post-operative day 1 | 
| Length of stay in the hospital/intensive care unit |  | until post-operative day 90 | 
| Hours on mechanical ventilation |  | until post-operative day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HES, HES 130, Hydroxyethyl starch