Blood Loss, SurgicalPhase 4HYPALBNCT03848507
Impact of Hyperoncotic Albumin to Support Blood Loss Replacement
A Phase 4 study testing albumin 20% 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 treatment is usually performed with either balanced crystalloid fluids or iso-oncotic colloids, (synthetic colloids, plasma and 5% albumin). Doubts have been raised about synthetic colloids (impairment of renal function and coagulation), and the natural albumin has 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?
- albumin 20%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- 18 Mar 2019to 18 Feb 2020
- 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
- Significant renal dysfunction: glomerular filtration rate < 60 ml/min/1,73 m² (Kidney Disease Outcomes Quality Initiative stage 3 or more )
- History of heart failure
- Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,
- 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: Impact of Hyperoncotic Albumin to Support Blood Loss Replacement on Plasma Volume Expansion in Cystectomy Patients.
Fluid treatment is usually performed with either balanced crystalloid fluids or iso-oncotic colloids, (synthetic colloids, plasma and 5% albumin). Doubts have been raised about synthetic colloids (impairment of renal function and coagulation), and the natural albumin has been used more extensively. Albumin is the main protein responsible for plasma oncotic pressure and its volume expansion effect. An alternative therapeutic option is the mobilization of tissue fluid by infusing a small amount of hyper-oncotic fluid like the 20% albumin solution (endogenous fluid recruitment).
The primary objective of this study is to test the effect of 20% albumin on plasma volume expansion and fluid recruitment in the frame of blood loss replacement during cystectomy using established fluid kinetic models.
The investigators expect that fluid replacement with crystalloid will be better sustained intravascularly with the administration of 20% albumin and be able to recruit fluid into the vascular compartment.
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 open 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 (crystalloids and colloids) to restore hydrated state and volemia.
Fluid treatment is usually performed with either balanced crystalloids fluids or iso-oncotic synthetic colloids, plasma or 5% albumin. Because crystalloids quickly equilibrate between the intravascular and interstitial volumes, they are mainly used to treat dehydration and temporary volume deficits. Iso-oncotic colloids remain intravascular for a prolonged period. 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. An alternative therapeutic option is the mobilization of tissue fluid by infusing a small amount of hyper-oncotic fluid like the 20% albumin solution (endogenous fluid recruitment).
There are still unknown aspects of the physiological effects of hyper-oncotic albumin. One of them is the, in this study investigated, effect of 20% albumin on plasma volume expansion, fluid recruitment, and crystalloid kinetic in the frame of blood loss replacement during cystectomy.
It is expected that fluid replacement with crystalloid will be better sustained intravascularly with the administration of 20% albumin.
- Conditions
- Blood Loss, Surgical, Fluid Retention
- Being tested
- albumin 20%
- Keywords
- hyperoncotic albumin, blood loss, fluid replacement, cystectomy
- 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.
albumin 20%Drug
Intravenous administration of 20% albumin during cystectomy
| Study group | Role | What they receive |
|---|---|---|
| 20% Albumin | Experimental | Administration of 3ml per kg bodyweight of 20% albumin within 30 min during cystectomy. Receives: Drug: albumin 20% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma volume expansion
Calculated by kinetics models
Measured: 5 hours
Secondary outcomes (3)
Colloid osmotic pressure
Measured by oncometer
Measured: 5 hours
Fluid balance
Composite score calculated according to fluid administered (crystalloid, colloids, blood products) and fluid loss (urine and blood)
Measured: 24 hours
Complications rate
Assessment of all complications occurring from postoperative day 1 to 90 according to the Clavien Dindo classification
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start18 Mar 2019
- Primary completion12 Feb 2020
- Study completion18 Feb 2020
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Wuethrich, MD, Principal investigator, Inselspital Bern Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03848507
- Sponsor's protocol ID
- HYPALB
- Acronym
- HYPALB
- Status last verified
- Feb 2020
- First submitted
- 19 Feb 2019
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hahn RG, Wuethrich PY, Zdolsek JH. Can perioperative hemodilution be monitored with non-invasive measurement of blood hemoglobin? BMC Anesthesiol. 2021 May 6;21(1):138. doi: 10.1186/s12871-021-01351-4.
PubMed 33957864Loffel LM, Hahn RG, Engel D, Wuethrich PY. Intraoperative Intravascular Effect of Lactated Ringer's Solution and Hyperoncotic Albumin During Hemorrhage in Cystectomy Patients. Anesth Analg. 2021 Aug 1;133(2):413-422. doi: 10.1213/ANE.0000000000005173.
PubMed 32947291
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Hyperoncotic Albumin to Support Blood Loss Replacement on Plasma Volume Expansion in Cystectomy Patients.
- ClinicalTrials.gov ID
- NCT03848507
- Acronym / sponsor ID
- HYPALB / HYPALB
- Conditions
- Blood Loss, Surgical, Fluid Retention
- Keywords
- hyperoncotic albumin, blood loss, fluid replacement, cystectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 12 Feb 2020 (actual)
- Study completion
- 18 Feb 2020 (actual)
- First posted
- 20 Feb 2019 (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 treatment is usually performed with either balanced crystalloid fluids or iso-oncotic colloids, (synthetic colloids, plasma and 5% albumin). Doubts have been raised about synthetic colloids (impairment of renal function and coagulation), and the natural albumin has been used more extensively. Albumin is the main protein responsible for plasma oncotic pressure and its volume expansion effect. An alternative therapeutic option is the mobilization of tissue fluid by infusing a small amount of hyper-oncotic fluid like the 20% albumin solution (endogenous fluid recruitment).
The primary objective of this study is to test the effect of 20% albumin on plasma volume expansion and fluid recruitment in the frame of blood loss replacement during cystectomy using established fluid kinetic models.
The investigators expect that fluid replacement with crystalloid will be better sustained intravascularly with the administration of 20% albumin and be able to recruit fluid into the vascular compartment.
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 open 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 (crystalloids and colloids) to restore hydrated state and volemia.
Fluid treatment is usually performed with either balanced crystalloids fluids or iso-oncotic synthetic colloids, plasma or 5% albumin. Because crystalloids quickly equilibrate between the intravascular and interstitial volumes, they are mainly used to treat dehydration and temporary volume deficits. Iso-oncotic colloids remain intravascular for a prolonged period. 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. An alternative therapeutic option is the mobilization of tissue fluid by infusing a small amount of hyper-oncotic fluid like the 20% albumin solution (endogenous fluid recruitment).
There are still unknown aspects of the physiological effects of hyper-oncotic albumin. One of them is the, in this study investigated, effect of 20% albumin on plasma volume expansion, fluid recruitment, and crystalloid kinetic in the frame of blood loss replacement during cystectomy.
It is expected that fluid replacement with crystalloid will be better sustained intravascularly with the administration of 20% albumin.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 20% Albumin | Experimental | Drug: albumin 20%Administration of 3ml per kg bodyweight of 20% albumin within 30 min during cystectomy. |
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 (6 listed)
- Significant renal dysfunction: glomerular filtration rate < 60 ml/min/1,73 m² (Kidney Disease Outcomes Quality Initiative stage 3 or more )
- History of heart failure
- Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,
- 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,
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%Intravenous administration of 20% albumin during cystectomy | Drug | 20% Albumin |
Primary outcome
Plasma volume expansion
Time frame: 5 hours
Calculated by kinetics models
3 secondary outcomes
Colloid osmotic pressure
Time frame: 5 hours
Fluid balance
Time frame: 24 hours
Complications rate
Time frame: 90 days
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 20 Feb 2020.
- Derived from this study: PubMed 33957864Hahn RG, Wuethrich PY, Zdolsek JH. Can perioperative hemodilution be monitored with non-invasive measurement of blood hemoglobin? BMC Anesthesiol. 2021 May 6;21(1):138. doi: 10.1186/s12871-021-01351-4.
- Derived from this study: PubMed 32947291Loffel LM, Hahn RG, Engel D, Wuethrich PY. Intraoperative Intravascular Effect of Lactated Ringer's Solution and Hyperoncotic Albumin During Hemorrhage in Cystectomy Patients. Anesth Analg. 2021 Aug 1;133(2):413-422. doi: 10.1213/ANE.0000000000005173.
- Individual participant dataSharing planned: No
Related trials for Blood Loss, Surgical
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Recruiting
Prospective, Multicenter, Randomized Controlled Phase III Trial of Biological Mesh for Alimentary Tract Reconstruction in Digestive Surgery
Digestive System Surgical Procedures, Anastomosis, Surgical
Recruiting
Middle Meningeal Artery Embolisation in Chronic Subdural Hematoma
Chronic Subdural Hematoma
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign
Active, not recruiting
Comparison of Intraoperative Outcomes of Microdebrider-Assisted Versus Conventional Functional Endoscopic Sinus Surgery in Patients With Sinonasal Polyposis
Nasal Polyps
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 Wuethrich, MD principal investigator
Inselspital Bern Switzerland
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 20% 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 6 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 20 Feb 2020. 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 NCT03848507, 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 20 Feb 2020.