A Phase 4 interventional study of Volulyte 6% and Ionolyte in Hypovolemia Due to Acute Blood Loss, sponsored by Fresenius Kabi. Completed at 22 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-05.
Sponsored by Fresenius Kabi · Phase 4, Interventional, and Treatment
The aim of the study is to investigate the safety of a 6% hydroxyethyl starch (HES) solution (Volulyte 6%) versus an electrolyte solution (Ionolyte) in trauma patients.
122 studies on the registry are indexed under Hypovolemia; 14 are open to participants now.
This study's enrollment of 238 is above the median of 40 across 61 interventional studies indexed under Hypovolemia.
Browse Hypovolemia studies →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.
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.
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.
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
Solution for infusion
Also known as: Ionolyte Electrolyte Solution
Composite endpoint of 90 day mortality and 90 day renal failure defined as biomarker increase as defined by AKIN stage 2 or RIFLE injury stage or need for RRT at any time during the first 3 months.
Time frame: 90 days
Serum creatinine
Time frame: 7 days post-trauma
Serum creatinine-based estimated glomerular filtration rate
Time frame: 7 days post-trauma
Cystatin-C
Time frame: 3 days post-trauma
Cystatin-C-based mean estimated glomerular filtration rate
Time frame: 3 days post-trauma
AKIN stages
Time frame: 7 days post-trauma
Highest AKIN stage reached on each day during the first week
Time frame: 7 days post-trauma
RIFLE stages
Time frame: 7 days post-trauma
Urine output (if available)
Time frame: 7 days post-trauma
Days on Renal Replacement Therapy
Time frame: 90 days after randomization
Patients on Renal Replacement Therapy
Time frame: 90 days after randomization
Platelet count
Time frame: 3 days post-trauma
International normalized ratio
Time frame: 3 days post-trauma
Activated partial thromboplastin time
Time frame: 3 days post-trauma
Adverse Events
Time frame: 90 days after randomization
Mortality
Time frame: 90 days after randomization
Length of Stay in ICU/hospital
Time frame: 90 days after randomization
C-reactive protein
Time frame: 3 days post-trauma
Hours on mechanical ventilation
Time frame: 7 days post-trauma
Total volume of administered investigational products
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 due to surgeries and trauma
Time frame: 7 days post-trauma
Heart rate
Time frame: 7 days post-trauma
Temperature
Time frame: 7 days post-trauma
Mean arterial pressure
Time frame: 7 days post-trauma
Systolic arterial blood pressure
Time frame: 7 days post-trauma
Diastolic arterial blood pressure
Time frame: 7 days post-trauma
Central venous pressure (if available)
Time frame: 7 days post-trauma
Partial pressure of carbon dioxide
Time frame: 3 days post-trauma
Partial pressure of oxygen
Time frame: 3 days post-trauma
Bicarbonate
Time frame: 3 days post-trauma
Arterial oxygen saturation
Time frame: 3 days post-trauma
Hemoglobin
Time frame: 3 days post-trauma
Hematocrit
Time frame: 3 days post-trauma
pH
Time frame: 3 days post-trauma
Base excess
Time frame: 3 days post-trauma
Lactate
Time frame: 3 days post-trauma
Central venous oxygen saturation (if available)
Time frame: 3 days post-trauma
Serum sodium
Time frame: 3 days post-trauma
Serum potassium
Time frame: 3 days post-trauma
Serum calcium
Time frame: 3 days post-trauma
Serum chloride
Time frame: 3 days post-trauma
Ran from Feb 2019 to primary completion in Jun 2022, 40 months.
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This study is completed, as verified in Aug 2022. 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