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| Name | Class |
|---|---|
| University Hospital, Linkoeping | OTHER |
| Karolinska University Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conscious healthy volunteers | Active Comparator | Intervention: intravenious infusion Drug: albumin 20% |
|
| Surgery under general anesthesia | Experimental | Intervention: intravenious infusion Drug: albumin 20% |
|
| Post-surgical inflammation | Experimental | Intervention: intravenious infusion Drug: albumin 20% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albumin 20% | Drug | Intervention: intravenious infusion Drug: albumin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Degree of plasma volume expansion | Calculated by volume kinetics | 5 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Increase in plasma oncotic pressure | Measured by oncometer | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert G Hahn, MD, PhD | Contact | 0046 8 55024000 | 4670 | robert.hahn@sll.se |
| Joachim Zdolsek, MD, PhD | Contact | 00456 70 3031434 | joachim.zdolsek@regionostergotland.se |
| Name | Affiliation | Role |
|---|---|---|
| Robert G Hahn, MD, PhD | Research Director, Södertälje sjukhus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linköping University Hospital | Recruiting | Linköping | 581 85 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15538944 | Background | 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. | |
| 22903119 | Background | Woodcock 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. |
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When the study is completed.
Data from the volunteer and postoperative patients are available in March 2018. The intraoperative patients are still being recruited
Contact the Project Leader
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 11, 2020 | |
| Reset | Aug 24, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 11, 2020 | Aug 24, 2020 |
| ID | Term |
|---|---|
| D014474 | Unconsciousness |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C525853 | galactosamine-conjugated serum albumin-conjugated-(rhodamine X)20 |
| D000418 | Albumins |
| ID | Term |
|---|---|
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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|
| 5 hours |
| Half-life of plasma volume expansion | Calculated from the restoration of the diluted blood hemoglobnin concentration | 5 hours |
| Karolinska University Hospital | Completed | Stockholm | 171 64 | Sweden |
| 21029460 | Background | Wiedermann 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. |
| 39375158 | Derived | Hahn 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. |
| 34797221 | Derived | Gunnstrom 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. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |