A Phase 4 interventional study of Volulyte 6% and Ionolyte in Hypovolaemia Due to Acute Blood Loss, sponsored by Fresenius Kabi. Completed at 61 sites in 10 countries. Open to participants aged 41 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-01-31.
Sponsored by Fresenius Kabi · Phase 4, Interventional, and Treatment
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.
Fresenius Kabi is the lead sponsor of 51 studies on the registry; 3 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Volulyte 6% solution for infusion
Drug: Volulyte 6%
Ionolyte solution for infusion
Drug: Ionolyte
Solution for infusion
Also known as: Hydroxyethyl starch 130/0.4
Solution for infusion
Also known as: Electrolyte solution
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
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
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
Time frame: until end of surgery
Diastolic arterial blood pressure
Time frame: until end of surgery
Central venous pressure (if available)
Time frame: 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]
Time frame: until 24 hours after investigational product treatment start
Partial pressure of carbon dioxide
Time frame: until end of surgery
Partial pressure of oxygen
Time frame: until end of surgery
Bicarbonate
Time frame: until end of surgery
Arterial oxygen saturation
Time frame: until end of surgery
Haemoglobin
Time frame: until post-operative day 3
Haematocrit
Time frame: until post-operative day 3
pH
Time frame: until end of surgery
Base Excess
Time frame: until end of surgery
Lactate
Time frame: until post-operative day 3
Central venous oxygen saturation (if available)
Time frame: until post-operative day 1
Serum sodium
Time frame: until post-operative day 1
Serum potassium
Time frame: until post-operative day 1
Serum calcium
Time frame: until post-operative day 1
Serum chloride
Time frame: until post-operative day 1
Length of stay in the hospital/intensive care unit
Time frame: until post-operative day 90
Hours on mechanical ventilation
Time frame: until post-operative day 7
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Hydroxyethyl Starch Derivatives