Edema SecondaryPhase 4(RAV)NCT03453320
Infusion Rate and Volume Kinetics for Hyperoncotic Albumine in Healthy Subjects
A Phase 4 study testing Albumin solution in people with Edema Secondary, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial summary
Treatment with colloidal solutions has during long time been a cornerstone within intensive care. Lately there has been a shift from synthetic colloids to natural albumine. One of these solutions is the hyperoncotic "Albumin 20%". Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Edema Secondary
- What is being tested?
- Albumin solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSweden
- Study dates
- 24 Feb 2018to 31 Jan 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, without allergies and with the age 18 years or above
Who cannot join
- Heart failure
- Signs of kidney injury/failure
- Severe allergies
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Treatment with colloidal solutions has during long time been a cornerstone within intensive care. Lately there has been a shift from synthetic colloids to natural albumine.
One of these solutions is the hyperoncotic "Albumin 20%". There are however still several aspects of the physiological effects of hyperoncotic albumin, that are not known.
In this study the main object is to study with what rate hyperoncotic albumin should be administered. Rapidly 30 minutes or slower 120 minutes.
Read the detailed description
Difference in volume expansion as well as fluid recruitment from the tissues depending on infusion rate is of interest.
Plasma volume expansion is measured using hemoglobin as a marker and fluid recruitment of tissue fluid is measured as a combination of plasma volume expansion and urinary output.
Healthy individuals are asked to refrain from eating and drinking the night before the study. Two hours before study start, the subjects may take a sandwich and a glas to drink.
After 15 minutes of rest baseline blood samples are taken. Subjects are randomised to receive two rates of albumin solution (Albumin 20%) 3 ml/kg bodyweight at two separate occasions. Once with an infusion time of 30 minutes, once with an infusion time of 120 minutes. Between the two infusions there will be an interval of 3 to 20 weeks. Randomization is performed to chose which rate the subjects start with. 6 in each Group (total 12).
During each occasion15 blood samples are collected, during a 6 hour period. Hemoglobin, plasma Sodium, colloid osmotic pressure and albumin are analysed. The total volume of blood collected will be 170 ml at each occasion when an albumin infusion is given.
Urinary output is measured and Urinary Sodium content is measured. Liberal fluid intake is recommended the same day and the next.
- Conditions
- Edema Secondary
- Being tested
- Albumin solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albumin solutionDrug
Infusion rate and effects
| Study group | Role | What they receive |
|---|---|---|
| Rapid - Slow | Experimental | Two infusions of 3 ml/kg bodyweight of hyperoncotic albumin 20%, with an interval of 3 to 20 weeks between.
First time rapid (30 minutes), second time slow (120 minutes). Albumin solution Receives: Drug: Albumin solution |
| Slow - Rapid | Experimental | Two infusions of 3 ml/kg bodyweight of hyperoncotic albumin 20%, with an interval of 3 to 20 weeks between.
First time rapid (120 minutes), second time slow (30 minutes). Albumin solution Receives: Drug: Albumin solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma volume
Albumin infusion expands the plasma volume and dilutes hemoglobin. The dilution of hemoglobin can be measured and is used to calculate the degree of plasma expansion.
Measured: 6 hours
Secondary outcomes (2)
Colloid osmotic pressure
Infusion of hyperoncotic albumin increases the colloid osmotic pressure of plasma. Fluid recruitment from the tissues however diminishes the increase of the colloid osmotic pressure. This effect is measured.
Measured: 6 hours
Fluid recruitment from tissues
The recruitment of fluid from the tissues due to the increase of colloid osmotic pressure is measured. The total recruitment of fluid from the tissues is the sum of the plasma volume dilution and urinary excretion.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start24 Feb 2018
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edema SecondaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joachim Zdolsek, University Hospital, Linkoeping
- Investigators
- Joachim Zdolsek, MD, PhD,Assoc prof, Principal investigator, University Hospital, Linkoeping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03453320
- Sponsor's protocol ID
- RAV
- Acronym
- (RAV)
- Status last verified
- May 2019
- First submitted
- 24 Feb 2018
- Last updated
- 29 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infusion Rate and Volume Kinetics for Hyperoncotic Albumine in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03453320
- Acronym / sponsor ID
- (RAV) / RAV
- Conditions
- Edema Secondary
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- 24 Feb 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 5 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Treatment with colloidal solutions has during long time been a cornerstone within intensive care. Lately there has been a shift from synthetic colloids to natural albumine.
One of these solutions is the hyperoncotic "Albumin 20%". There are however still several aspects of the physiological effects of hyperoncotic albumin, that are not known.
In this study the main object is to study with what rate hyperoncotic albumin should be administered. Rapidly 30 minutes or slower 120 minutes.
Detailed description
Difference in volume expansion as well as fluid recruitment from the tissues depending on infusion rate is of interest.
Plasma volume expansion is measured using hemoglobin as a marker and fluid recruitment of tissue fluid is measured as a combination of plasma volume expansion and urinary output.
Healthy individuals are asked to refrain from eating and drinking the night before the study. Two hours before study start, the subjects may take a sandwich and a glas to drink.
After 15 minutes of rest baseline blood samples are taken. Subjects are randomised to receive two rates of albumin solution (Albumin 20%) 3 ml/kg bodyweight at two separate occasions. Once with an infusion time of 30 minutes, once with an infusion time of 120 minutes. Between the two infusions there will be an interval of 3 to 20 weeks. Randomization is performed to chose which rate the subjects start with. 6 in each Group (total 12).
During each occasion15 blood samples are collected, during a 6 hour period. Hemoglobin, plasma Sodium, colloid osmotic pressure and albumin are analysed. The total volume of blood collected will be 170 ml at each occasion when an albumin infusion is given.
Urinary output is measured and Urinary Sodium content is measured. Liberal fluid intake is recommended the same day and the next.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rapid - Slow | Experimental | Drug: Albumin solutionTwo infusions of 3 ml/kg bodyweight of hyperoncotic albumin 20%, with an interval of 3 to 20 weeks between. First time rapid (30 minutes), second time slow (120 minutes). Albumin solution |
| Slow - Rapid | Experimental | Drug: Albumin solutionTwo infusions of 3 ml/kg bodyweight of hyperoncotic albumin 20%, with an interval of 3 to 20 weeks between. First time rapid (120 minutes), second time slow (30 minutes). Albumin solution |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy, without allergies and with the age 18 years or above
Key exclusion criteria (4 listed)
- Heart failure
- Signs of kidney injury/failure
- Severe allergies
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albumin solutionInfusion rate and effects | Drug | Rapid - Slow, Slow - Rapid |
Primary outcome
Plasma volume
Time frame: 6 hours
Albumin infusion expands the plasma volume and dilutes hemoglobin. The dilution of hemoglobin can be measured and is used to calculate the degree of plasma expansion.
2 secondary outcomes
Colloid osmotic pressure
Time frame: 6 hours
Fluid recruitment from tissues
Time frame: 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joachim Zdolsek, MD, PhD,Assoc prof principal investigator
University Hospital, Linkoeping
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Albumin solution in people with Edema Secondary, run by University Hospital, Linkoeping at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma volume (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2019.