Pleural Effusions Post Coronary Artery Bypass GraftPhase 4NCT06681415
Efficacy of 20% Human Albumin in Reducing Pleural Effusion After Cardiopulmonary Bypass
A Phase 4 study testing Adding 100ml of 20% human albumin to cardiopulmonary bypass priming solution in people with Pleural Effusions Post Coronary Artery Bypass Graft and Hypoxia, run by Pauls Stradins Clinical University Hospital at 1 site in Latvia.
Trial summary
Human albumin is a widely used additive in cardiopulmonary bypass all around the world, but its effect on various outcomes has been debated. The goal of this observational study is to compare the effect of 100 ml 20% human albumin addition to cardiopulmonary bypass on pleural effusion development after open heart… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusions Post Coronary Artery Bypass Graft, Hypoxia, Hypoalbuminemia
- What is being tested?
- Adding 100ml of 20% human albumin to cardiopulmonary bypass priming solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteLatvia
- Study dates
- 1 Sep 2022to 1 Jan 2024
- 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
- Individuals scheduled for elective open-heart surgeries, encompassing procedures such as ascending aorta surgery, coronary artery bypass grafting, and heart valve replacement or repair, either independently or in combination, without the use of hypothermic circulatory arrest.
Who cannot join
- reduced left ventricular ejection fraction (EF < 50%),
- chronic kidney disease,
- chronic lung disease,
- pre-existing anemia,
- pathological chest X-ray findings before surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial on the Efficacy of 20% Human Albumin in Reducing Pleural Effusion After Cardiopulmonary Bypass
Human albumin is a widely used additive in cardiopulmonary bypass all around the world, but its effect on various outcomes has been debated. The goal of this observational study is to compare the effect of 100 ml 20% human albumin addition to cardiopulmonary bypass on pleural effusion development after open heart surgery.
The main question it aims to answer is:
- Does albumin, in addition to cardiopulmonary bypass, reduce pleural effusion development after open heart surgery? Patients will go under elective open heart surgery. Investigators will compare pleural effusion volume on the first day after surgery between patients who received albumin and those who didn't.
Read the detailed description
This study constituted a prospective single-center randomized controlled trial conducted at the Center of Cardiac Surgery within Pauls Stradins Clinical University Hospital, Riga, Latvia. The study received approval from the State Agency of Medicines of the Republic of Latvia on September 20, 2021 for a drug usage observation study and the medical ethics committee of Pauls Stradins Clinical University Hospital (Chairperson Prof P. Stradins) under reference number 260821-11L, dated August 26, 2021. All participants provided written informed consent before enrolment.All participants provided written informed consent before enrolment.
The study targeted 70 individuals scheduled for elective open-heart surgeries, encompassing procedures such as ascending aorta surgery, coronary artery bypass grafting, and heart valve replacement or repair, either independently or in combination, without the use of hypothermic circulatory arrest. Investigators did not include patients with a history of reduced left ventricular ejection fraction (EF < 50%), chronic kidney disease, chronic lung disease, pre-existing anemia, and pathological chest X-ray findings before surgery. Random allocation into the two groups-those receiving an additional 100 ml of 20% human albumin and those receiving standard CPB priming solution-was done in a 1:1 ratio.
Interventions The standard CPB priming volume of 1050 ml, comprising isochloremic solution Deltajonin® and 250 ml of 15% Mannitol, was used. The study group replaced 100 ml of Deltajonin® solution with 100 ml of 20% human albumin. Investigators used cold crystalloid cardioplegia in all cases. Patients were mechanically ventilated according to the local protocol using FiO2 - 0.6, 6 ml/kg tidal volume, and PEEP was set at five mmHg. After extubation, oxygen was administered via a non-rebreathing face mask at a flow rate of 10 l/min. Blood gas analysis (pO2, pCO2, FiO2/O2 ratio, A - a gradients, Lactate) was conducted following the local protocol. Serum albumin levels were measured preoperatively, 6 and 12 hours post-operation. Normal albumin was defined as ≥35 g/L, mild 30-35 g/L, moderate 25-30 g/L and severe hypoalbuminemia as <25 g/L. Colloid oncotic pressure (COP) was calculated using the formula by J C Hoefs: COP = A (1.058 G + 0.163 A + 3.11).
Thorax CT scans were performed on all patients on the first postoperative day, with subsequent image analysis conducted by a single radiologist. The radiologist measured pleural effusion size (cm), and investigators calculated effusion volume (ml) using the formula Volume = 0.365 × b^3 - 4.529 × b^2 + 159.723 × b - 88.377 by Hazlinger et al. Where b is the maximum effusion depth measured in the axial (transverse) imaging plane. If patients were hemodynamically unstable with ST-segment abnormalities, investigators refused their transportation to a CT scan.
The primary outcomes were the effect of albumin addition on serum albumin level in the early postoperative period and the development of pleural effusion.
The secondary outcome measure was the effect of albumin addition on respiratory function, measured by blood gas analysis, in the early postoperative period.
- Being tested
- Adding 100ml of 20% human albumin to cardiopulmonary bypass priming solution
- Keywords
- Pleural effusion following cardiopulmonary bypass
- Medical subject headings
- Hypoxia, Hypoalbuminemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adding 100ml of 20% human albumin to cardiopulmonary bypass priming solutionDrug
Adding albumin to the priming solution can help reduce hemodilution and consequent extracardiac complications by maintaining colloid oncotic pressure. Albumin helps counteract the intravascular fluid shift to the extravascular space and reduces the risk of complications associated with fluid imbalance.
Postoperative pulmonary complications following CPB can significantly impact postoperative outcomes. Patients developing PPC have prolonged mechanical ventilation, extended hospitalisation, longer ICU stays, and elevated postoperative mortality. One of the most common PPCs following CPB is pleural effusion.
Our primary objective was to evaluate the effectiveness of adding 100 ml of 20% human albumin to the CPB priming solution compared to standard priming, with a specific focus on its potential role in reducing the occurrence of pleural effusion.
| Study group | Role | What they receive |
|---|---|---|
| Albumin group | Experimental | The standard CPB priming volume of 1050 ml, comprising isochloremic solution Deltajonin® and 250 ml of 15% Mannitol, was used. The study group replaced 100 ml of Deltajonin® solution with 100 ml of 20% human albumin. Receives: Drug: Adding 100ml of 20% human albumin to cardiopulmonary bypass priming solution |
| No-albumin group | No intervention | The standard CPB priming volume of 1050 ml, comprising isochloremic solution Deltajonin® and 250 ml of 15% Mannitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pleural effusion (centimetres) in thoracic CT images and calculated in millilitres.
Thorax CT scans were performed on all patients on the first postoperative day, with subsequent image analysis conducted by a single radiologist. The radiologist measured pleural effusion size (cm).
Measured: Thorax CT scans were performed on all patients on the first postoperative day.
Pleural effusion in thoracic CT images and calculated in millilitres.
Thorax CT scans were performed on all patients on the first postoperative day, with subsequent image analysis conducted by a single radiologist. The investigators calculated effusion volume (ml).
Measured: Thorax CT scans were performed on all patients on the first postoperative day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start1 Sep 2022
- Primary completion1 Dec 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural Effusions Post Coronary Artery Bypass GraftStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pauls Stradins Clinical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Riga Stradins University
- Responsible party
- Sponsor
- Investigators
- Eva Strike, MD, PhD, Study director, Head of the cardiac anesthesiology and ICU department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681415
- Sponsor's protocol ID
- PaulsStradins
- Status last verified
- Nov 2024
- First submitted
- 4 Nov 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on the Efficacy of 20% Human Albumin in Reducing Pleural Effusion After Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT06681415
- Acronym / sponsor ID
- PaulsStradins
- Keywords
- Pleural effusion following cardiopulmonary bypass
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Pauls Stradins Clinical University HospitalUniversity, hospital or other
- Collaborators
- Riga Stradins University
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 8 Nov 2024 (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.
Human albumin is a widely used additive in cardiopulmonary bypass all around the world, but its effect on various outcomes has been debated. The goal of this observational study is to compare the effect of 100 ml 20% human albumin addition to cardiopulmonary bypass on pleural effusion development after open heart surgery.
The main question it aims to answer is:
- Does albumin, in addition to cardiopulmonary bypass, reduce pleural effusion development after open heart surgery? Patients will go under elective open heart surgery. Investigators will compare pleural effusion volume on the first day after surgery between patients who received albumin and those who didn't.
Detailed description
This study constituted a prospective single-center randomized controlled trial conducted at the Center of Cardiac Surgery within Pauls Stradins Clinical University Hospital, Riga, Latvia. The study received approval from the State Agency of Medicines of the Republic of Latvia on September 20, 2021 for a drug usage observation study and the medical ethics committee of Pauls Stradins Clinical University Hospital (Chairperson Prof P. Stradins) under reference number 260821-11L, dated August 26, 2021. All participants provided written informed consent before enrolment.All participants provided written informed consent before enrolment.
The study targeted 70 individuals scheduled for elective open-heart surgeries, encompassing procedures such as ascending aorta surgery, coronary artery bypass grafting, and heart valve replacement or repair, either independently or in combination, without the use of hypothermic circulatory arrest. Investigators did not include patients with a history of reduced left ventricular ejection fraction (EF < 50%), chronic kidney disease, chronic lung disease, pre-existing anemia, and pathological chest X-ray findings before surgery. Random allocation into the two groups-those receiving an additional 100 ml of 20% human albumin and those receiving standard CPB priming solution-was done in a 1:1 ratio.
Interventions The standard CPB priming volume of 1050 ml, comprising isochloremic solution Deltajonin® and 250 ml of 15% Mannitol, was used. The study group replaced 100 ml of Deltajonin® solution with 100 ml of 20% human albumin. Investigators used cold crystalloid cardioplegia in all cases. Patients were mechanically ventilated according to the local protocol using FiO2 - 0.6, 6 ml/kg tidal volume, and PEEP was set at five mmHg. After extubation, oxygen was administered via a non-rebreathing face mask at a flow rate of 10 l/min. Blood gas analysis (pO2, pCO2, FiO2/O2 ratio, A - a gradients, Lactate) was conducted following the local protocol. Serum albumin levels were measured preoperatively, 6 and 12 hours post-operation. Normal albumin was defined as ≥35 g/L, mild 30-35 g/L, moderate 25-30 g/L and severe hypoalbuminemia as <25 g/L. Colloid oncotic pressure (COP) was calculated using the formula by J C Hoefs: COP = A (1.058 G + 0.163 A + 3.11).
Thorax CT scans were performed on all patients on the first postoperative day, with subsequent image analysis conducted by a single radiologist. The radiologist measured pleural effusion size (cm), and investigators calculated effusion volume (ml) using the formula Volume = 0.365 × b^3 - 4.529 × b^2 + 159.723 × b - 88.377 by Hazlinger et al. Where b is the maximum effusion depth measured in the axial (transverse) imaging plane. If patients were hemodynamically unstable with ST-segment abnormalities, investigators refused their transportation to a CT scan.
The primary outcomes were the effect of albumin addition on serum albumin level in the early postoperative period and the development of pleural effusion.
The secondary outcome measure was the effect of albumin addition on respiratory function, measured by blood gas analysis, in the early postoperative period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Albumin group | Experimental | Drug: Adding 100ml of 20% human albumin to cardiopulmonary bypass priming solutionThe standard CPB priming volume of 1050 ml, comprising isochloremic solution Deltajonin® and 250 ml of 15% Mannitol, was used. The study group replaced 100 ml of Deltajonin® solution with 100 ml of 20% human albumin. |
| No-albumin group | No intervention | –The standard CPB priming volume of 1050 ml, comprising isochloremic solution Deltajonin® and 250 ml of 15% Mannitol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals scheduled for elective open-heart surgeries, encompassing procedures such as ascending aorta surgery, coronary artery bypass grafting, and heart valve replacement or repair, either independently or in combination, without the use of hypothermic circulatory arrest.
Key exclusion criteria (5 listed)
- reduced left ventricular ejection fraction (EF < 50%),
- chronic kidney disease,
- chronic lung disease,
- pre-existing anemia,
- pathological chest X-ray findings before 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 |
|---|---|---|
| Adding 100ml of 20% human albumin to cardiopulmonary bypass priming solutionAdding albumin to the priming solution can help reduce hemodilution and consequent extracardiac complications by maintaining colloid oncotic pressure. Albumin helps counteract the intravascular fluid shift to the extravascular space and reduces the risk of complications associated with fluid imbalance. Postoperative pulmonary complications following CPB can significantly impact postoperative outcomes. Patients developing PPC have prolonged mechanical ventilation, extended hospitalisation, longer ICU stays, and elevated postoperative mortality. One of the most common PPCs following CPB is pleural effusion. Our primary objective was to evaluate the effectiveness of adding 100 ml of 20% human albumin to the CPB priming solution compared to standard priming, with a specific focus on its potential role in reducing the occurrence of pleural effusion. | Drug | Albumin group |
Primary outcome
Pleural effusion (centimetres) in thoracic CT images and calculated in millilitres.
Time frame: Thorax CT scans were performed on all patients on the first postoperative day.
Thorax CT scans were performed on all patients on the first postoperative day, with subsequent image analysis conducted by a single radiologist. The radiologist measured pleural effusion size (cm).
Pleural effusion in thoracic CT images and calculated in millilitres.
Time frame: Thorax CT scans were performed on all patients on the first postoperative day.
Thorax CT scans were performed on all patients on the first postoperative day, with subsequent image analysis conducted by a single radiologist. The investigators calculated effusion volume (ml).
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 8 Nov 2024.
- Individual participant dataSharing planned: No
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.
Eva Strike, MD, PhD study director
Head of the cardiac anesthesiology and ICU department
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 Adding 100ml of 20% human albumin to cardiopulmonary bypass priming solution in people with Pleural Effusions Post Coronary Artery Bypass Graft and Hypoxia, run by Pauls Stradins Clinical University Hospital at 1 site in Latvia.
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 1 inclusion and 5 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 8 Nov 2024. 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 Latvia. 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?
Pleural effusion (centimetres) in thoracic CT images and calculated in millilitres. (time frame: Thorax CT scans were performed on all patients on the first postoperative day.). The study lists 2 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 8 Nov 2024.