Blood Loss, SurgicalPhase 4VASCALBNCT05391607
Comparison Between Hyperoncotic and Isooncotic Albumin to Support Blood Loss Replacement
A Phase 4 study testing Hyperoncotic Albumin 20% and Isooncotic Albumin 5% in people with Blood Loss, Surgical and Fluid Retention, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Fluid intravascular replacement is usually performed with either balanced crystalloids or iso-oncotic colloids, (synthetic colloids, plasma and 5% albumin). Doubts have been raised about synthetic colloids, and albumin solutions have been used more extensively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Loss, Surgical, Fluid Retention
- What is being tested?
- Hyperoncotic Albumin 20% and Isooncotic Albumin 5%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSwitzerland
- Study dates
- 25 May 2022to 10 Apr 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non emergent radical cystectomy with urinary diversion
- Adult: older than 18 years
- Written informed consent
Who cannot join
- Contraindications to the class of drugs under study (i.e: known hypersensitivity/ allergy to class of drugs or to the investigational product).
- Renal insufficiency: GFR: <60ml/min/1.73m2 (KDIGO Clinical Practice Guideline for Acute Kidney Injury, stage 3 and over).
- History of heart failure.
- Use of diuretic treatment.
- Women who are pregnant or breast feeding (exclusion of surgery per se).
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
- Enrolment of the investigator, his/her family members, employees and other dependent persons.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Patrick Wuethrich, Department of Anaesthesiology and Pain Therapy, University Hospital Bern Inselspital Bern
Bern, Canton of Bern, 3010
About this study
Official title: Randomized Trial of Intraoperative Intravascular Effect of Hyper-oncotic 20% Albumin, Iso-oncotic 5% Albumin and Ringer Lactate During Haemorrhage in Cystectomy. A Prospective Randomized Active-controlled Single Centre Trial
Fluid intravascular replacement is usually performed with either balanced crystalloids or iso-oncotic colloids, (synthetic colloids, plasma and 5% albumin). Doubts have been raised about synthetic colloids, and albumin solutions have been used more extensively. Albumin is the main protein responsible for plasma oncotic pressure and its volume expansion effect. The mobilization of extravascular fluid by infusing a hyper-oncotic solution like 20% albumin solution has been shown, causing endogenous fluid recruitment and blood volume expansion.
The primary objective of this study is to compare the effect on plasma volume expansion and fluid recruitment of 3 different types of fluids (Albumin 5% and Albumin 20% and Ringer-lactate) during the hemorrhagic phase of the cystectomy procedure.
Secondary objectives are the assessment of the hemodynamic parameters during surgery and the follow-up of pro-ANP and pro-BNP peptides. Glycocalyx proteins will be followed to evaluate endothelial wall shedding and microcirculation damages.
Read the detailed description
Bladder cancer occurs mainly in old comorbid patients. The standard treatment of localized muscle invasive bladder cancer is pelvic lymph node dissection and radical cystectomy with urinary diversion. Optimal perioperative fluid management for this surgery is challenging and still controversial in terms of how much to perfuse, choice of fluids to restore hydrated state and volemia.
Fluid treatment is usually performed with either balanced crystalloids fluids or iso-oncotic synthetic colloids, or albumin 5%. Because crystalloids quickly equilibrate between the intravascular and interstitial volumes, they are mainly used to treat dehydration and temporary volume deficits. Doubts have been raised about synthetic colloids and the natural albumin has been used more extensively. Albumin is the main protein responsible for plasma oncotic pressure and its volume expansion effect.
Iso-oncotic colloids (Albumine 5%) remain intravascular for a prolonged period, but they play a neutral role in terms of endogenous fluid recruitment, as the oncotic pressure is equilibrated between the intra- and extra- vascular territories.
An alternative therapeutic option is the mobilization of tissue fluid by infusing a small amount of hyper-oncotic fluid like the albumin 20% solution, which has showed the advantage in its blood volume expansion capacities over crystalloids (endogenous fluid recruitment).
The effects of the Albumin 20% solution have until now never been compared in a same perioperative setting to the Albumin 5% nor to Ringer-lactate solution.
The investigators will evaluate the physiological effects and their outcomes between these fluid therapies in the frame of blood loss replacement during the hemorrhagic part of cystectomy procedures. The investigators will as well assess the variation of hemodynamic parameters (pro-ANP, pro-BNP) and the resulting microcirculation damages (endothelial wall shedding).
- Conditions
- Blood Loss, Surgical, Fluid Retention
- Being tested
- Hyperoncotic Albumin 20%, Isooncotic Albumin 5%, Ringer's Lactate Crystalloid Solutions (control group)
- Keywords
- hyperoncotic, isooncotic, albumin 20%, albumin 5%, ringer lactate, blood loss, hemorrhage, fluid replacement, intravascular effect, volume expansion, cystectomy, pro-ANP, pro-BNP, glycocalyx proteins, microcirculation damages, endothelial shedding, CD138/syndecan 1, heparan sulfate, hyaluronic acid
- Medical subject headings
- Blood Loss, Surgical, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperoncotic Albumin 20%Drug
Also called Albumin 20%
Intravenous administration during removal of the bladder (i.e. the bleeding part) of cystectomy procedures.
Isooncotic Albumin 5%Drug
Also called Albumin 5%
Intravenous administration of Albumin 5% 12ml/kg (ideal body weight) completed by a Ringer-lactate crystalloid ratio 1:1 to total amount of blood loss during removal of the bladder (i.e. the bleeding part) of cystectomy procedures.
Ringer's Lactate Crystalloid Solutions (control group)Drug
Also called Ringer Lactate
Intravenous administration of Ringer-lactate ratio 3:1 of total of blood loss during removal of the bladder (i.e. the bleeding part) of cystectomy procedures.
| Study group | Role | What they receive |
|---|---|---|
| Albumin 20% | Experimental | 3mL/kg (ideal body weight) completed by a Ringer-lactate crystalloid ratio 1:1 to total amount of blood loss during removal of the bladder (i.e. the bleeding part) of cystectomy procedures. Receives: Drug: Hyperoncotic Albumin 20% |
| Albumin 5% | Experimental | 12ml/kg (ideal body weight) completed by a Ringer-lactate crystalloid ratio 1:1 to total amount of blood loss during removal of the bladder (i.e. the bleeding part) of cystectomy procedures. Receives: Drug: Isooncotic Albumin 5% |
| Ringer-lactate | Active comparator | Ratio 3:1 of total of blood loss during removal of the bladder (i.e. the bleeding part) of cystectomy procedures. Receives: Drug: Ringer's Lactate Crystalloid Solutions (control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma volume expansion
Difference in plasma volume expansion of albumin 20%, albumin 5% and Ringer lactate calculated by volume kinetics
Measured: 5 hours
Secondary outcomes (5)
Biological markers (pro-ANP and pro-BNP)
Variation and comparison of kinetics hemodynamics biological markers such as pro-ANP and pro-BNP
Measured: 24 hours
Cardiac output (CO)
Evolution of cardiac output (CO) at the start of surgery, begin of infusion, stop of infusion and end of surgery.
Measured: 5 hours
Endothelial damage
Assessment of microcirculation damage due to peroperative stress and fluid therapy through Glycocalyx proteins (CD-138/syndecan 1, heparan sulfate and hyaluronic acid).
Measured: 24 hours
Stroke volume (SV)
Evolution of stroke volume at the start of surgery, begin of infusion, stop of infusion and end of surgery.
Measured: 5 hours
Pleth variability index (PVI)
Evolution of pleth variability index (PVI) at the start of surgery, begin of infusion, stop of infusion and end of surgery.
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 posted26 May 2022
- Study start25 May 2022
- Primary completion30 Mar 2023
- Study completion10 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Blood Loss, SurgicalStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Y Wuethrich, MD, Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391607
- Sponsor's protocol ID
- VASCALB
- Acronym
- VASCALB
- Status last verified
- May 2022
- First submitted
- 17 May 2022
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jardot F, Hahn RG, Huber M, Wuethrich PY. Detection of hypovolemia by non-invasive hemodynamic monitoring during major surgery using Ringer s solution, 5% albumin, or 20% albumin as infusion fluid: a post-hoc analysis of a randomized clinical trial. Crit Care. 2025 Mar 23;29(1):132. doi: 10.1186/s13054-025-05357-z.
PubMed 40122881Jardot F, Hahn RG, Engel D, Beilstein CM, Wuethrich PY. Blood volume and hemodynamics during treatment of major hemorrhage with Ringer solution, 5% albumin, and 20% albumin: a single-center randomized controlled trial. Crit Care. 2024 Feb 5;28(1):39. doi: 10.1186/s13054-024-04821-6.
PubMed 38317178
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Intraoperative Intravascular Effect of Hyper-oncotic 20% Albumin, Iso-oncotic 5% Albumin and Ringer Lactate During Haemorrhage in Cystectomy. A Prospective Randomized Active-controlled Single Centre Trial
- ClinicalTrials.gov ID
- NCT05391607
- Acronym / sponsor ID
- VASCALB / VASCALB
- Conditions
- Blood Loss, Surgical, Fluid Retention
- Keywords
- hyperoncotic, isooncotic, albumin 20%, albumin 5%, ringer lactate, blood loss, hemorrhage, fluid replacement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 25 May 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 10 Apr 2023 (actual)
- First posted
- 26 May 2022 (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.
Fluid intravascular replacement is usually performed with either balanced crystalloids or iso-oncotic colloids, (synthetic colloids, plasma and 5% albumin). Doubts have been raised about synthetic colloids, and albumin solutions have been used more extensively. Albumin is the main protein responsible for plasma oncotic pressure and its volume expansion effect. The mobilization of extravascular fluid by infusing a hyper-oncotic solution like 20% albumin solution has been shown, causing endogenous fluid recruitment and blood volume expansion.
The primary objective of this study is to compare the effect on plasma volume expansion and fluid recruitment of 3 different types of fluids (Albumin 5% and Albumin 20% and Ringer-lactate) during the hemorrhagic phase of the cystectomy procedure.
Secondary objectives are the assessment of the hemodynamic parameters during surgery and the follow-up of pro-ANP and pro-BNP peptides. Glycocalyx proteins will be followed to evaluate endothelial wall shedding and microcirculation damages.
Detailed description
Bladder cancer occurs mainly in old comorbid patients. The standard treatment of localized muscle invasive bladder cancer is pelvic lymph node dissection and radical cystectomy with urinary diversion. Optimal perioperative fluid management for this surgery is challenging and still controversial in terms of how much to perfuse, choice of fluids to restore hydrated state and volemia.
Fluid treatment is usually performed with either balanced crystalloids fluids or iso-oncotic synthetic colloids, or albumin 5%. Because crystalloids quickly equilibrate between the intravascular and interstitial volumes, they are mainly used to treat dehydration and temporary volume deficits. Doubts have been raised about synthetic colloids and the natural albumin has been used more extensively. Albumin is the main protein responsible for plasma oncotic pressure and its volume expansion effect.
Iso-oncotic colloids (Albumine 5%) remain intravascular for a prolonged period, but they play a neutral role in terms of endogenous fluid recruitment, as the oncotic pressure is equilibrated between the intra- and extra- vascular territories.
An alternative therapeutic option is the mobilization of tissue fluid by infusing a small amount of hyper-oncotic fluid like the albumin 20% solution, which has showed the advantage in its blood volume expansion capacities over crystalloids (endogenous fluid recruitment).
The effects of the Albumin 20% solution have until now never been compared in a same perioperative setting to the Albumin 5% nor to Ringer-lactate solution.
The investigators will evaluate the physiological effects and their outcomes between these fluid therapies in the frame of blood loss replacement during the hemorrhagic part of cystectomy procedures. The investigators will as well assess the variation of hemodynamic parameters (pro-ANP, pro-BNP) and the resulting microcirculation damages (endothelial wall shedding).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Albumin 20% | Experimental | Drug: Hyperoncotic Albumin 20%3mL/kg (ideal body weight) completed by a Ringer-lactate crystalloid ratio 1:1 to total amount of blood loss during removal of the bladder (i.e. the bleeding part) of cystectomy procedures. |
| Albumin 5% | Experimental | Drug: Isooncotic Albumin 5%12ml/kg (ideal body weight) completed by a Ringer-lactate crystalloid ratio 1:1 to total amount of blood loss during removal of the bladder (i.e. the bleeding part) of cystectomy procedures. |
| Ringer-lactate | Active comparator | Drug: Ringer's Lactate Crystalloid Solutions (control group)Ratio 3:1 of total of blood loss during removal of the bladder (i.e. the bleeding part) of cystectomy procedures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Non emergent radical cystectomy with urinary diversion
- Adult: older than 18 years
- Written informed consent
Key exclusion criteria (7 listed)
- Contraindications to the class of drugs under study (i.e: known hypersensitivity/ allergy to class of drugs or to the investigational product).
- Renal insufficiency: GFR: <60ml/min/1.73m2 (KDIGO Clinical Practice Guideline for Acute Kidney Injury, stage 3 and over).
- History of heart failure.
- Use of diuretic treatment.
- Women who are pregnant or breast feeding (exclusion of surgery per se).
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 |
|---|---|---|
| Hyperoncotic Albumin 20%Also: Albumin 20%Intravenous administration during removal of the bladder (i.e. the bleeding part) of cystectomy procedures. | Drug | Albumin 20% |
| Isooncotic Albumin 5%Also: Albumin 5%Intravenous administration of Albumin 5% 12ml/kg (ideal body weight) completed by a Ringer-lactate crystalloid ratio 1:1 to total amount of blood loss during removal of the bladder (i.e. the bleeding part) of cystectomy procedures. | Drug | Albumin 5% |
| Ringer's Lactate Crystalloid Solutions (control group)Also: Ringer LactateIntravenous administration of Ringer-lactate ratio 3:1 of total of blood loss during removal of the bladder (i.e. the bleeding part) of cystectomy procedures. | Drug | Ringer-lactate |
Primary outcome
Plasma volume expansion
Time frame: 5 hours
Difference in plasma volume expansion of albumin 20%, albumin 5% and Ringer lactate calculated by volume kinetics
5 secondary outcomes
Biological markers (pro-ANP and pro-BNP)
Time frame: 24 hours
Cardiac output (CO)
Time frame: 5 hours
Endothelial damage
Time frame: 24 hours
Stroke volume (SV)
Time frame: 5 hours
Pleth variability index (PVI)
Time frame: 5 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 13 Apr 2023.
- Derived from this study: PubMed 40122881Jardot F, Hahn RG, Huber M, Wuethrich PY. Detection of hypovolemia by non-invasive hemodynamic monitoring during major surgery using Ringer s solution, 5% albumin, or 20% albumin as infusion fluid: a post-hoc analysis of a randomized clinical trial. Crit Care. 2025 Mar 23;29(1):132. doi: 10.1186/s13054-025-05357-z.
- Derived from this study: PubMed 38317178Jardot F, Hahn RG, Engel D, Beilstein CM, Wuethrich PY. Blood volume and hemodynamics during treatment of major hemorrhage with Ringer solution, 5% albumin, and 20% albumin: a single-center randomized controlled trial. Crit Care. 2024 Feb 5;28(1):39. doi: 10.1186/s13054-024-04821-6.
- Individual participant dataSharing planned: No
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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.
Patrick Y Wuethrich, MD principal investigator
Insel Gruppe AG, University Hospital Bern
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 Hyperoncotic Albumin 20% and Isooncotic Albumin 5% in people with Blood Loss, Surgical and Fluid Retention, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 3 inclusion and 7 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 13 Apr 2023. 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 Switzerland. 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 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 NCT05391607, which also lists 2 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 13 Apr 2023.