Endothelial DysfunctionPRIME part IINCT05647200
Optimization of Prime Fluid Strategy to Preserve Microcirculatory Perfusion During Cardiac Surgery With Cardiopulmonary Bypass, Part II
A study testing Treatment: additional albumin during cardiopulmonary bypass in people with Endothelial Dysfunction and Hemolysis, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
Acute microcirculatory perfusion disturbances is common in critical illness and associated with increased morbidity and mortality. Recent findings by our group showed that microcirculatory perfusion is disturbed during cardiac surgery with cardiopulmonary bypass (CPB) and remain disturbed up to 72 (seventy two) hours… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endothelial Dysfunction, Hemolysis, Fluid Overload
- What is being tested?
- Treatment: additional albumin during cardiopulmonary bypass
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Oct 2023to 15 Jan 2025
- Phase
- Interventional
- 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
- Adult subjects
- Informed consent
- Elective coronary artery bypass surgery with cardiopulmonary bypass
Who cannot join
- Emergency operations
- Re-operation
- Elective thoracic aortic surgery
- Elective valve surgery
- Combined procedure CABG and valve surgery
- Known allergy for human albumin or gelofusine
Trial locations and contacts
1 site in 1 country.
A.B.A. Vonk, MD PhD contact
Netherlands1 site
Amsterdam UMC, AMC location
Amsterdam, North Holland, 1105AZ
About this study
Official title: Optimization of Prime Fluid Strategy to Preserve Microcirculatory Perfusion During Cardiac Surgery With Cardiopulmonary Bypass
Acute microcirculatory perfusion disturbances is common in critical illness and associated with increased morbidity and mortality. Recent findings by our group showed that microcirculatory perfusion is disturbed during cardiac surgery with cardiopulmonary bypass (CPB) and remain disturbed up to 72 (seventy two) hours after surgery. A cardiopulmonary bypass is a machine which takes over heart and lung function, during the procedure. The disturbed microcirculation is associated with organ dysfunction induced by cardiac surgery using CPB, which is frequently seen (up to forty two percent, 42%) and results in a six-fold increase in mortality rate. The underlying cause of disturbed microcirculation is a higher endothelial permeability and vascular leakage and are a consequence of systemic inflammation, hemodilution (dilution of blood), hypothermia and hemolysis (breakdown of red blood cells). To gain the knowledge regarding disturbed microcirculation the investigators previously showed that hemodilution attributes to this disturbed perfusion. Hemodilution lowers colloid oncotic pressure (COP). Also, COP is affected by free hemoglobin, which increases with hemolysis and attributes to a disturbed microcirculation following CPB. This is interesting, as to the best of our knowledge, the effect of minimizing hemodilution and hemolysis during cardiac surgery on the microcirculatory perfusion has never been investigated, but could be the key factor in reducing organ dysfunction.
Read the detailed description
In this project the investigators focus on reducing microcirculatory perfusion disturbances by exploring therapeutic approaches with different prime fluid strategies, by acting on COP (part I) and free hemoglobin scavenging with human albumin (part II).
In part I, patients undergoing elective coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass will be randomized in three groups receiving different prime fluid strategies. The study endpoint is the reduction in functional capillary density during the perioperative period. Sublingual microcirculatory measurements and blood sampling will take place after induction of anesthesia, during and after surgery to determine microcirculatory perfusion and parameters for hemodilution, hemolysis, COP, markers for endothelial damage and glycocalyx shedding. Measurements start on the day of surgery and end one day after surgery. For part I see trial registration: PRIME, part I.
In part II, participants will be randomized in two groups receiving the first dose directly after aortic cross clamping and blood cardioplegia administration, and the second dose after the third blood cardioplegia administration (± 30 min after the first dose).The most optimal prime fluid in order to preserve microcirculatory perfusion from study one, will be used as prime fluid in the second study. Microcirculatory perfusion parameters will be measured at time points comparable with study one. Blood samples are taken to determine markers for hemodilution, hemolysis, COP and endothelial damage and glycocalyx shedding.
- Conditions
- Endothelial Dysfunction, Hemolysis, Fluid Overload
- Being tested
- Treatment: additional albumin during cardiopulmonary bypass, control: additional ringers during cardiopulmonary bypass
- Keywords
- Microcirculation, Cardiopulmonary bypass, Colloid oncotic pressure, Hemodilution, Hemolysis
- Medical subject headings
- Hemolysis, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment: additional albumin during cardiopulmonary bypassDrug
Treatment group (T): administration of 100 mL Human Albumin (20%), first dose directly after aortic cross clamping and blood cardioplegia administration, second dose after the third blood cardioplegia administration (± 30 min after the first dose).
control: additional ringers during cardiopulmonary bypassDrug
Control group (C): administration of 100 mL of Ringer's solution, first dose directly after aortic cross clamping and blood cardioplegia administration, second dose after the third blood cardioplegia administration (± 30 min after the first dose).
| Study group | Role | What they receive |
|---|---|---|
| T (Treatment) | Active comparator | The most optimal prime fluid from part I (based on the effect on perfused vessel density) + additional albumin during cardiopulmonary bypass. Receives: Drug: Treatment: additional albumin during cardiopulmonary bypass |
| C (control) | Sham comparator | The most optimal prime fluid from part I (based on the effect on perfused vessel density) + additional ringers during cardiopulmonary bypass. Receives: Drug: control: additional ringers during cardiopulmonary bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perfused vessel density (PVD, mm mm-²)
reflecting microcirculatory diffusion capacity
Measured: Timepoint 1: 5-10 min after induction of anesthesia
Perfused vessel density (PVD, mm mm-²)
reflecting microcirculatory diffusion capacity
Measured: Timepoint 2: 5-10 min after aortic cross clamping
Perfused vessel density (PVD, mm mm-²)
reflecting microcirculatory diffusion capacity
Measured: Timepoint 3: 5-10 min after weaning from cardiopulmonary bypass
Perfused vessel density (PVD, mm mm-²)
reflecting microcirculatory diffusion capacity
Measured: Timepoint 4: 15-30 min after arrival on the intensive care unit
Perfused vessel density (PVD, mm mm-²)
reflecting microcirculatory diffusion capacity
Measured: Timepoint 5: twenty four (24) hours after arrival on the intensive care unit
Secondary outcomes (15)
Colloid oncotic pressure (COP, mmHg)
colloid oncotic pressure in plasma
Measured: T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.
albumin (g L-¹)
concentration of albumin in plasma
Measured: T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.
hemolysis index (H-index)
the grade of hemolysis in plasma
Measured: T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.
haptoglobin (g L-¹)
concentration of haptoglobin in plasma
Measured: T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.
NO consumption (μmol L-¹)
consumption of nitric oxide in plasma
Measured: T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.
syndecan-1 (ng/ml)
Concentration of syndecan-1 in plasma
Measured: T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.
heparan sulphate (ng/ml)
concentration of heparan sulphate in plasma
Measured: T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.
hemoglobin (Hb, mmol L-¹)
concentration of hemoglobin in serum
Measured: T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.
hematocrit (Ht, L L-¹)
hematocrit in serum
Measured: T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.
perioperative use of packed red blood cells (PRBCs, mL)
amount of packed red blood cells
Measured: intraoperative and postoperative up to 24 hours postoperative
fluid balance (mL)
fluid balance
Measured: intraoperative and postoperative up to 24 hours postoperative
fluid requirements (mL)
Amount of fluids required
Measured: intraoperative and postoperative up to 24 hours postoperative
Total vessel density (TVD, mm mm-²)
density of capillaries reflecting the functional state of the microcirculatory diffusion capacity
Measured: T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.
Proportion of perfused vessels (PPV, %)
reflecting the aspect of heterogeneity of microcirculatory perfusion
Measured: T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.
Heterogeneity index
reflecting the aspect of heterogeneity of microcirculatory perfusion
Measured: T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start15 Oct 2023 (estimated)
- Primary completion15 Jul 2024 (estimated)
- Study completion15 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In two consecutive randomized controlled trials, we study the effect of prime fluid strategies on perfused vessel density (part I) and the effect of additional albumin during cardiopulmonary bypass compared with ringers on perfused vessel density (part II). In this study part (II), the effect of additional albumin during cardiopulmonary bypass compared with ringers on perfused vessel density.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander B.A. Vonk, Amsterdam UMC, location VUmc
- Investigators
- A.B.A. Vonk, MD, PhD, Principal investigator, Cardiothoracic surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647200
- Sponsor's protocol ID
- NL82500.029.22, part II
- Acronym
- PRIME part II
- Status last verified
- Apr 2023
- First submitted
- 21 Nov 2022
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Prime Fluid Strategy to Preserve Microcirculatory Perfusion During Cardiac Surgery With Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT05647200
- Acronym / sponsor ID
- PRIME part II / NL82500.029.22, part II
- Conditions
- Endothelial Dysfunction, Hemolysis, Fluid Overload
- Keywords
- Microcirculation, Cardiopulmonary bypass, Colloid oncotic pressure, Hemodilution, Hemolysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 15 Oct 2023 (estimated)
- Primary completion
- 15 Jul 2024 (estimated)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 12 Dec 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.
Acute microcirculatory perfusion disturbances is common in critical illness and associated with increased morbidity and mortality. Recent findings by our group showed that microcirculatory perfusion is disturbed during cardiac surgery with cardiopulmonary bypass (CPB) and remain disturbed up to 72 (seventy two) hours after surgery. A cardiopulmonary bypass is a machine which takes over heart and lung function, during the procedure. The disturbed microcirculation is associated with organ dysfunction induced by cardiac surgery using CPB, which is frequently seen (up to forty two percent, 42%) and results in a six-fold increase in mortality rate. The underlying cause of disturbed microcirculation is a higher endothelial permeability and vascular leakage and are a consequence of systemic inflammation, hemodilution (dilution of blood), hypothermia and hemolysis (breakdown of red blood cells). To gain the knowledge regarding disturbed microcirculation the investigators previously showed that hemodilution attributes to this disturbed perfusion. Hemodilution lowers colloid oncotic pressure (COP). Also, COP is affected by free hemoglobin, which increases with hemolysis and attributes to a disturbed microcirculation following CPB. This is interesting, as to the best of our knowledge, the effect of minimizing hemodilution and hemolysis during cardiac surgery on the microcirculatory perfusion has never been investigated, but could be the key factor in reducing organ dysfunction.
Detailed description
In this project the investigators focus on reducing microcirculatory perfusion disturbances by exploring therapeutic approaches with different prime fluid strategies, by acting on COP (part I) and free hemoglobin scavenging with human albumin (part II).
In part I, patients undergoing elective coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass will be randomized in three groups receiving different prime fluid strategies. The study endpoint is the reduction in functional capillary density during the perioperative period. Sublingual microcirculatory measurements and blood sampling will take place after induction of anesthesia, during and after surgery to determine microcirculatory perfusion and parameters for hemodilution, hemolysis, COP, markers for endothelial damage and glycocalyx shedding. Measurements start on the day of surgery and end one day after surgery. For part I see trial registration: PRIME, part I.
In part II, participants will be randomized in two groups receiving the first dose directly after aortic cross clamping and blood cardioplegia administration, and the second dose after the third blood cardioplegia administration (± 30 min after the first dose).The most optimal prime fluid in order to preserve microcirculatory perfusion from study one, will be used as prime fluid in the second study. Microcirculatory perfusion parameters will be measured at time points comparable with study one. Blood samples are taken to determine markers for hemodilution, hemolysis, COP and endothelial damage and glycocalyx shedding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- In two consecutive randomized controlled trials, we study the effect of prime fluid strategies on perfused vessel density (part I) and the effect of additional albumin during cardiopulmonary bypass compared with ringers on perfused vessel density (part II). In this study part (II), the effect of additional albumin during cardiopulmonary bypass compared with ringers on perfused vessel density.
| Arm | Type | Receives |
|---|---|---|
| T (Treatment) | Active comparator | Drug: Treatment: additional albumin during cardiopulmonary bypassThe most optimal prime fluid from part I (based on the effect on perfused vessel density) + additional albumin during cardiopulmonary bypass. |
| C (control) | Sham comparator | Drug: control: additional ringers during cardiopulmonary bypassThe most optimal prime fluid from part I (based on the effect on perfused vessel density) + additional ringers during cardiopulmonary bypass. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult subjects
- Informed consent
- Elective coronary artery bypass surgery with cardiopulmonary bypass
Key exclusion criteria (6 listed)
- Emergency operations
- Re-operation
- Elective thoracic aortic surgery
- Elective valve surgery
- Combined procedure CABG and valve surgery
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 |
|---|---|---|
| Treatment: additional albumin during cardiopulmonary bypassTreatment group (T): administration of 100 mL Human Albumin (20%), first dose directly after aortic cross clamping and blood cardioplegia administration, second dose after the third blood cardioplegia administration (± 30 min after the first dose). | Drug | T (Treatment) |
| control: additional ringers during cardiopulmonary bypassControl group (C): administration of 100 mL of Ringer's solution, first dose directly after aortic cross clamping and blood cardioplegia administration, second dose after the third blood cardioplegia administration (± 30 min after the first dose). | Drug | C (control) |
Primary outcome
Perfused vessel density (PVD, mm mm-²)
Time frame: Timepoint 1: 5-10 min after induction of anesthesia
reflecting microcirculatory diffusion capacity
Perfused vessel density (PVD, mm mm-²)
Time frame: Timepoint 2: 5-10 min after aortic cross clamping
reflecting microcirculatory diffusion capacity
Perfused vessel density (PVD, mm mm-²)
Time frame: Timepoint 3: 5-10 min after weaning from cardiopulmonary bypass
reflecting microcirculatory diffusion capacity
Perfused vessel density (PVD, mm mm-²)
Time frame: Timepoint 4: 15-30 min after arrival on the intensive care unit
reflecting microcirculatory diffusion capacity
Perfused vessel density (PVD, mm mm-²)
Time frame: Timepoint 5: twenty four (24) hours after arrival on the intensive care unit
reflecting microcirculatory diffusion capacity
15 secondary outcomes
Colloid oncotic pressure (COP, mmHg)
Time frame: T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.
albumin (g L-¹)
Time frame: T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.
hemolysis index (H-index)
Time frame: T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.
haptoglobin (g L-¹)
Time frame: T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.
NO consumption (μmol L-¹)
Time frame: T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.
syndecan-1 (ng/ml)
Time frame: T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.
heparan sulphate (ng/ml)
Time frame: T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.
hemoglobin (Hb, mmol L-¹)
Time frame: T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.
hematocrit (Ht, L L-¹)
Time frame: T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.
perioperative use of packed red blood cells (PRBCs, mL)
Time frame: intraoperative and postoperative up to 24 hours postoperative
fluid balance (mL)
Time frame: intraoperative and postoperative up to 24 hours postoperative
fluid requirements (mL)
Time frame: intraoperative and postoperative up to 24 hours postoperative
Total vessel density (TVD, mm mm-²)
Time frame: T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.
Proportion of perfused vessels (PPV, %)
Time frame: T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.
Heterogeneity index
Time frame: T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Individual participant dataSharing planned: Yes. Upon request
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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.
A.B.A. Vonk, MD PhD contact
A.B.A. Vonk, MD, PhD principal investigator
Cardiothoracic surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment: additional albumin during cardiopulmonary bypass in people with Endothelial Dysfunction and Hemolysis, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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: status not confirmed, as of the sponsor's last update on 26 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 Netherlands. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 A.M. Beukers, MD (020-4444444, a.beukers@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perfused vessel density (PVD, mm mm-²) (time frame: Timepoint 1: 5-10 min after induction of anesthesia). The study lists 5 primary outcomes in all. 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 26 Apr 2023.