UnconsciousPhase 4AlbuminNCT02556580
Volume Kinetics for 20% Albumin in Different Clinical Situations
A Phase 4 study testing Albumin 20% in people with Unconscious and Inflammation, run by Sodertalje Hospital at 2 sites in Sweden.
Trial summary
The study aims to determine the degree of plasma volume expansion and the half-life of the plasma volume expansion when 3 mL/kg of hyperoncotic (20%) albumin if infused over 30 minutes in conscious healthy volunteers, in patients undergoing surgery under general anesthesia, and on the day after major surgery when the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Unconscious, Inflammation
- What is being tested?
- Albumin 20%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesSweden
- Study dates
- Feb 2016to 1 Apr 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers.
- Patients in ASA classes I-II scheduled for surgery.
Who cannot join
- Expected major hemorrhage during surgery.
- Blood hemoglobin concentration of < 10 g/dL.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites, 1 recruiting
- Recruiting
Linköping University Hospital
Linköping, 581 85
Joachim Zdolsek, MD, PhD, 0046 70 3031434, joachim.zdolsek@regionostergotland.se
- Completed
Karolinska University Hospital
Stockholm, 171 64
About this study
Official title: Volume Kinetics for 20% Albumin in Conscious and Anesthetized Humans With and Without Inflammation
The study aims to determine the degree of plasma volume expansion and the half-life of the plasma volume expansion when 3 mL/kg of hyperoncotic (20%) albumin if infused over 30 minutes in conscious healthy volunteers, in patients undergoing surgery under general anesthesia, and on the day after major surgery when the patient is in a post surgical inflammatory state. The study also examines the increase in the plasma colloid osmotic pressure as a result of this infusion and its possible influence on markers of kidney damage.
Read the detailed description
15 volunteers, 15 patients undergoing surgery and 15 patients in the post-surgical phase will be recruited for this study because they have different degrees of vasodilatation and inflammation, which are factors of potential importance to the effectiveness of plasma volume expansion with albumin 20%. Hyperoncotic albumin should logically recruit fluid from the interstitial fluid space, but this possibility has recently been questioned in the "revised Starling equation".
The degree of plasma volume expansion and also the half-life will be estimated by population volume kinetics which uses serial analyses of the blood hemoglobin concentration and a summary measure of the excreted urine during the 5-hour experiment to calculate these outcome measures.
There is a risk that hyperoncotic solutions cause pre-renal anuria due to the rise in plasma oncotic pressure. As a safety measure we will assess the plasma oncotic pressure and relevant biomarkers of renal function during the experiments. The experiments will be ended with a slow infusion of 1 L of Ringer´s acetate to dilute any raised oncotic pressure.
- Conditions
- Unconscious, Inflammation
- Being tested
- Albumin 20%
- Keywords
- albumin, surgery, inflammation, volume kinetics
- Medical subject headings
- Unconsciousness, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albumin 20%Drug
Also called Albumin in healthy volunteers
Intervention: intravenious infusion Drug: albumin
| Study group | Role | What they receive |
|---|---|---|
| Conscious healthy volunteers | Active comparator | Intervention: intravenious infusion Drug: albumin 20% Receives: Drug: Albumin 20% |
| Surgery under general anesthesia | Experimental | Intervention: intravenious infusion Drug: albumin 20% Receives: Drug: Albumin 20% |
| Post-surgical inflammation | Experimental | Intervention: intravenious infusion Drug: albumin 20% Receives: Drug: Albumin 20% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of plasma volume expansion
Calculated by volume kinetics
Measured: 5 hours
Secondary outcomes (3)
Increase in plasma oncotic pressure
Measured by oncometer
Measured: 5 hours
Possible effect on biomarkers of kidney injury
Urinary albumin excretion (unit: mmol of albumin per mmol of urinary creatinine) and urinary neutrophil gelatinase-associated lipocalin (NGAL) excretion (unit: µg/L per mmol of creatinine).
Measured: 5 hours
Half-life of plasma volume expansion
Calculated from the restoration of the diluted blood hemoglobnin concentration
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study startFeb 2016
- Primary completion31 Dec 2018 (estimated)
- Study completion1 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for UnconsciousStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sodertalje Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Linkoeping, Karolinska University Hospital
- Responsible party
- Principal investigator, Robert Hahn, Sodertalje Hospital
- Investigators
- Robert G Hahn, MD, PhD, Principal investigator, Research Director, Södertälje sjukhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02556580
- Sponsor's protocol ID
- Albumin April 2015
- Acronym
- Albumin
- Status last verified
- Mar 2018
- First submitted
- 24 May 2015
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: When the study is completed.
Publications
Hedin A, Hahn RG. Volume expansion and plasma protein clearance during intravenous infusion of 5% albumin and autologous plasma. Clin Sci (Lond). 2005 Mar;108(3):217-24. doi: 10.1042/CS20040303.
PubMed 15538944Woodcock TM, Woodcock TE. Revised Starling equation predicts pulmonary edema formation during fluid loading in the critically ill with presumed hypovolemia. Crit Care Med. 2012 Sep;40(9):2741-2; author reply 2742. doi: 10.1097/CCM.0b013e31825ae6c9. No abstract available.
PubMed 22903119Wiedermann CJ, Dunzendorfer S, Gaioni LU, Zaraca F, Joannidis M. Hyperoncotic colloids and acute kidney injury: a meta-analysis of randomized trials. Crit Care. 2010;14(5):R191. doi: 10.1186/cc9308. Epub 2010 Oct 28.
PubMed 21029460Hahn RG, Zdolsek M, Gunnstrom M, Hasselgren E, Zdolsek JH. Diuretic responses to Ringer's solution and 20% albumin at different arterial pressures. Physiol Rep. 2024 Oct;12(19):e70069. doi: 10.14814/phy2.70069.
PubMed 39375158Gunnstrom M, Zdolsek JH, Hahn RG. Plasma Volume Expansion and Fluid Kinetics of 20% Albumin During General Anesthesia and Surgery Lasting for More Than 5 Hours. Anesth Analg. 2022 Jun 1;134(6):1270-1279. doi: 10.1213/ANE.0000000000005802. Epub 2021 Nov 18.
PubMed 34797221
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volume Kinetics for 20% Albumin in Conscious and Anesthetized Humans With and Without Inflammation
- ClinicalTrials.gov ID
- NCT02556580
- Acronym / sponsor ID
- Albumin / Albumin April 2015
- Conditions
- Unconscious, Inflammation
- Keywords
- albumin, surgery, inflammation, volume kinetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Sodertalje HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Linkoeping, Karolinska University Hospital
- Study start
- Feb 2016 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 1 Apr 2019 (estimated)
- First posted
- 22 Sep 2015 (estimated)
- 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.
The study aims to determine the degree of plasma volume expansion and the half-life of the plasma volume expansion when 3 mL/kg of hyperoncotic (20%) albumin if infused over 30 minutes in conscious healthy volunteers, in patients undergoing surgery under general anesthesia, and on the day after major surgery when the patient is in a post surgical inflammatory state. The study also examines the increase in the plasma colloid osmotic pressure as a result of this infusion and its possible influence on markers of kidney damage.
Detailed description
15 volunteers, 15 patients undergoing surgery and 15 patients in the post-surgical phase will be recruited for this study because they have different degrees of vasodilatation and inflammation, which are factors of potential importance to the effectiveness of plasma volume expansion with albumin 20%. Hyperoncotic albumin should logically recruit fluid from the interstitial fluid space, but this possibility has recently been questioned in the "revised Starling equation".
The degree of plasma volume expansion and also the half-life will be estimated by population volume kinetics which uses serial analyses of the blood hemoglobin concentration and a summary measure of the excreted urine during the 5-hour experiment to calculate these outcome measures.
There is a risk that hyperoncotic solutions cause pre-renal anuria due to the rise in plasma oncotic pressure. As a safety measure we will assess the plasma oncotic pressure and relevant biomarkers of renal function during the experiments. The experiments will be ended with a slow infusion of 1 L of Ringer´s acetate to dilute any raised oncotic pressure.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conscious healthy volunteers | Active comparator | Drug: Albumin 20%Intervention: intravenious infusion Drug: albumin 20% |
| Surgery under general anesthesia | Experimental | Drug: Albumin 20%Intervention: intravenious infusion Drug: albumin 20% |
| Post-surgical inflammation | Experimental | Drug: Albumin 20%Intervention: intravenious infusion Drug: albumin 20% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy volunteers.
- Patients in ASA classes I-II scheduled for surgery.
Key exclusion criteria (2 listed)
- Expected major hemorrhage during surgery.
- Blood hemoglobin concentration of < 10 g/dL.
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 20%Also: Albumin in healthy volunteersIntervention: intravenious infusion Drug: albumin | Drug | Conscious healthy volunteers, Post-surgical inflammation, Surgery under general anesthesia |
Primary outcome
Degree of plasma volume expansion
Time frame: 5 hours
Calculated by volume kinetics
3 secondary outcomes
Increase in plasma oncotic pressure
Time frame: 5 hours
Possible effect on biomarkers of kidney injury
Time frame: 5 hours
Half-life of plasma volume expansion
Time frame: 5 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
- Background: PubMed 15538944Hedin A, Hahn RG. Volume expansion and plasma protein clearance during intravenous infusion of 5% albumin and autologous plasma. Clin Sci (Lond). 2005 Mar;108(3):217-24. doi: 10.1042/CS20040303.
- Background: PubMed 22903119Woodcock TM, Woodcock TE. Revised Starling equation predicts pulmonary edema formation during fluid loading in the critically ill with presumed hypovolemia. Crit Care Med. 2012 Sep;40(9):2741-2; author reply 2742. doi: 10.1097/CCM.0b013e31825ae6c9. No abstract available.
- Background: PubMed 21029460Wiedermann CJ, Dunzendorfer S, Gaioni LU, Zaraca F, Joannidis M. Hyperoncotic colloids and acute kidney injury: a meta-analysis of randomized trials. Crit Care. 2010;14(5):R191. doi: 10.1186/cc9308. Epub 2010 Oct 28.
- Derived from this study: PubMed 39375158Hahn RG, Zdolsek M, Gunnstrom M, Hasselgren E, Zdolsek JH. Diuretic responses to Ringer's solution and 20% albumin at different arterial pressures. Physiol Rep. 2024 Oct;12(19):e70069. doi: 10.14814/phy2.70069.
- Derived from this study: PubMed 34797221Gunnstrom M, Zdolsek JH, Hahn RG. Plasma Volume Expansion and Fluid Kinetics of 20% Albumin During General Anesthesia and Surgery Lasting for More Than 5 Hours. Anesth Analg. 2022 Jun 1;134(6):1270-1279. doi: 10.1213/ANE.0000000000005802. Epub 2021 Nov 18.
- Individual participant dataSharing planned: Yes. When the study is completed.
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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.
Robert G Hahn, MD, PhD principal investigator
Research Director, Södertälje sjukhus
2 sites 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 20% in people with Unconscious and Inflammation, run by Sodertalje Hospital at 2 sites 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert G Hahn, MD, PhD (0046 8 55024000 ext. 4670, robert.hahn@sll.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of plasma volume expansion (time frame: 5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02556580, which also lists 5 linked publications.
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 20 Mar 2018.