Postoperative ComplicationsALBUTEPNCT04839432
Crystalloids vs Albumin Prime Solution and Postoperative Pulmonary Complications
An observational study of Postoperative Complications, run by Erasme University Hospital at 1 site in France.
Trial summary
In 2019, the investigators initiated a new priming fluid therapy strategy in the cardiopulmonary bypass (CPB) machine for patients undergoing pulmonary endarterectomy surgery. It consisted in a transition from a "pure" primarly balanced crystalloid priming fluid strategy to a 4% human albumin priming fluid-strategy in… Read more about this study
- Who is it for?
- Ages 14 to 99 years
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- implementation of albumin solution in the priming of the cardiopulmonary bypass machine
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2018to 31 Mar 2020
- Phase
- Observational
- 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 14 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All consecutive patients undergoing pulmonary endarterectomy surgery from 2018 to 2019 ( a two years study period)
Who may be able to join
- All consecutive patients undergoing pulmonary endarterectomy surgery
Who cannot join
- Patients with important missing data
- Patients undergoing combined surgery
- Patients undergoing an emergency pulmonary endarterectomy surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of 4% Albumin Prime Solution for Cardiopulmonary Bypass on Postoperative Pulmonary Complications In Patients Undergoing Pulmonary Endarterectomy: A Propensity-adjusted Analysis
In 2019, the investigators initiated a new priming fluid therapy strategy in the cardiopulmonary bypass (CPB) machine for patients undergoing pulmonary endarterectomy surgery. It consisted in a transition from a "pure" primarly balanced crystalloid priming fluid strategy to a 4% human albumin priming fluid-strategy in addition to a low volume of balanced crystalloid solution. The rationale was the theoritical assumption that albumin leads to better intravascular volume expansion compared to crystalloid and therefore could reduce overall volume requirement during surgery and consequently potentially decrease the incidence of postoperative pulmonary complications. The objective of this propensity-matched study was to evaluate the effectiveness of this intervention
Read the detailed description
Intravenous fluid is usually needed (and sometime in important amount) to increase intravascular volume during cardiac surgery and to prime the cardiopulmonary bypass (CPB) circuit. In this context, albumin has been frequently used as the ideal fluid choice. Although albumin has the disadvantage to be much more expensive than crystalloids and not to be free from immunological reactions, this solution provides a more sustained volume effect that a similar volume of crystalloid which may result in smaller volumes of resuscitation fluid being administered. It also better preserves the on-bypass oncotic pressure and reduce extravascular lung water. These considerations are important especially during pulmonary thromboendarterectomy surgery (PTE), a high-risk procedure which aims to resect thromboembolic material. Reperfusion lung injury (RLI) and/or acute respiratory distress syndrome (ARDS), are the most encountered postoperative pulmonary complications and are significant risks factors of morbi-mortality. As data suggest that RLI and ARDS are high-permeability phenomenon, cautious is required to avoid fluid accumulation/overload during this complex procedure. In addition, this surgical procedure has a relatively high CPB duration which can induce a systemic inflammatory response syndrome, damage the endothelial glycocalyx and vascular barrier where crystalloids may extravagates and accumulates in the lungs. On the contrary, albumin solution used during the priming of CPB can favorably preserve oncotic pressure, have a protective effect on endothelial glycocalyx and better maintain vascular barrier competence, preventing interstitial edema and potential pulmonary complications.
In March 2019, the investigators initiated a new priming fluid policy strategy aiming at replacing our traditional pure crystalloid fluid administration for an albumin one in order to decrease the relatively high-rate of pulmonary complications observed in the investigators patients.
The objective of this propensity-matched study was to evaluate the effectiveness of this intervention
- Conditions
- Postoperative Complications
- Being tested
- implementation of albumin solution in the priming of the cardiopulmonary bypass machine
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implementation of albumin solution in the priming of the cardiopulmonary bypass machineBehavioural
In March 2019, the investigators initiated a new priming fluid policy strategy aiming at replacing our traditional pure crystalloid fluid administration for an albumin one in order to decrease the relatively high-rate of observed pulmonary complications
| Study group | Role | What they receive |
|---|---|---|
| Crystalloids group | Patients had only a balanced crystalloid solution in the priming of the cardiopulmonary bypass (pre interventional group) | |
| albumin group | Patients had only a 4% albumin solution in addtion to a very low volume of a balanced crystalloid solution in the priming of the cardiopulmonary bypass (post interventional group) Receives: Behavioral: implementation of albumin solution in the priming of the cardiopulmonary bypass machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
pulmonary complications
a composite of two pulmonary complications ( reperfusion lung syndrome and/or acute respiratory distress syndrome)
Measured: postoperative day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start1 Jan 2018
- Primary completion31 Dec 2019
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandre Joosten, MD PhD, Erasme University Hospital
- Investigators
- Amelie Delaporte, MD, Principal investigator, Marie lannelongue
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839432
- Sponsor's protocol ID
- IRB 00012157
- Acronym
- ALBUTEP
- Status last verified
- Apr 2021
- First submitted
- 7 Apr 2021
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 4% Albumin Prime Solution for Cardiopulmonary Bypass on Postoperative Pulmonary Complications In Patients Undergoing Pulmonary Endarterectomy: A Propensity-adjusted Analysis
- ClinicalTrials.gov ID
- NCT04839432
- Acronym / sponsor ID
- ALBUTEP / IRB 00012157
- Conditions
- Postoperative Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 9 Apr 2021 (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.
In 2019, the investigators initiated a new priming fluid therapy strategy in the cardiopulmonary bypass (CPB) machine for patients undergoing pulmonary endarterectomy surgery. It consisted in a transition from a "pure" primarly balanced crystalloid priming fluid strategy to a 4% human albumin priming fluid-strategy in addition to a low volume of balanced crystalloid solution. The rationale was the theoritical assumption that albumin leads to better intravascular volume expansion compared to crystalloid and therefore could reduce overall volume requirement during surgery and consequently potentially decrease the incidence of postoperative pulmonary complications. The objective of this propensity-matched study was to evaluate the effectiveness of this intervention
Detailed description
Intravenous fluid is usually needed (and sometime in important amount) to increase intravascular volume during cardiac surgery and to prime the cardiopulmonary bypass (CPB) circuit. In this context, albumin has been frequently used as the ideal fluid choice. Although albumin has the disadvantage to be much more expensive than crystalloids and not to be free from immunological reactions, this solution provides a more sustained volume effect that a similar volume of crystalloid which may result in smaller volumes of resuscitation fluid being administered. It also better preserves the on-bypass oncotic pressure and reduce extravascular lung water. These considerations are important especially during pulmonary thromboendarterectomy surgery (PTE), a high-risk procedure which aims to resect thromboembolic material. Reperfusion lung injury (RLI) and/or acute respiratory distress syndrome (ARDS), are the most encountered postoperative pulmonary complications and are significant risks factors of morbi-mortality. As data suggest that RLI and ARDS are high-permeability phenomenon, cautious is required to avoid fluid accumulation/overload during this complex procedure. In addition, this surgical procedure has a relatively high CPB duration which can induce a systemic inflammatory response syndrome, damage the endothelial glycocalyx and vascular barrier where crystalloids may extravagates and accumulates in the lungs. On the contrary, albumin solution used during the priming of CPB can favorably preserve oncotic pressure, have a protective effect on endothelial glycocalyx and better maintain vascular barrier competence, preventing interstitial edema and potential pulmonary complications.
In March 2019, the investigators initiated a new priming fluid policy strategy aiming at replacing our traditional pure crystalloid fluid administration for an albumin one in order to decrease the relatively high-rate of pulmonary complications observed in the investigators patients.
The objective of this propensity-matched study was to evaluate the effectiveness of this intervention
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crystalloids group | – | –Patients had only a balanced crystalloid solution in the priming of the cardiopulmonary bypass (pre interventional group) |
| albumin group | – | Behavioral: implementation of albumin solution in the priming of the cardiopulmonary bypass machinePatients had only a 4% albumin solution in addtion to a very low volume of a balanced crystalloid solution in the priming of the cardiopulmonary bypass (post interventional group) |
Who may qualify
- Ages
- 14 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All consecutive patients undergoing pulmonary endarterectomy surgery from 2018 to 2019 ( a two years study period)
Key inclusion criteria (1 listed)
- All consecutive patients undergoing pulmonary endarterectomy surgery
Key exclusion criteria (3 listed)
- Patients with important missing data
- Patients undergoing combined surgery
- Patients undergoing an emergency pulmonary endarterectomy 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 |
|---|---|---|
| implementation of albumin solution in the priming of the cardiopulmonary bypass machineIn March 2019, the investigators initiated a new priming fluid policy strategy aiming at replacing our traditional pure crystalloid fluid administration for an albumin one in order to decrease the relatively high-rate of observed pulmonary complications | Behavioural | albumin group |
Primary outcome
pulmonary complications
Time frame: postoperative day 7
a composite of two pulmonary complications ( reperfusion lung syndrome and/or acute respiratory distress syndrome)
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 27 Apr 2021.
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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.
Amelie Delaporte, MD principal investigator
Marie lannelongue
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications, run by Erasme University Hospital at 1 site in France.
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 3 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 27 Apr 2021. 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 France. 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.
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?
pulmonary complications (time frame: postoperative day 7). 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 27 Apr 2021.