Coronary Artery Bypass Graft SurgeryNCT04652375
Outcomes After Albumin Vs Lactated Ringer's Solution in CABG and AVR Procedures
A study testing Albumin Solution and Lactated Ringer's Solution in people with Coronary Artery Bypass Graft Surgery and Aortic Valve Replacement, run by Yale University at 1 site in United States.
Trial summary
This is a prospective, randomized, double-blinded study to compare the use of albumin versus lactated Ringer's solution in patients undergoing coronary artery bypass graft surgery and in patients undergoing aortic valve replacement surgery and evaluate the incidence of acute kidney injury as a primary outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass Graft Surgery, Aortic Valve Replacement
- What is being tested?
- Albumin Solution and Lactated Ringer's Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 26 Jul 2022
- 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
- All patients greater than 18 years of age undergoing CABG and AVR procedures
Who cannot join
- Low ejection fraction (<20%) End stage renal disease Chronic renal insufficiency Pre-operative Inotropic (eg. Dobutamine) or vasoactive IV infusions (e.g, norepinephrine)
- Jehovah's Witness Emergent surgery (e.g, intra-aortic balloon pump) Pre-operative acute kidney injury based on AKIN criteria Non English speaking patients
- Jehovah's Witness population will be excluded regardless of their preference with accepting Albumin because sometimes PRBC are used as part of ongoing resuscitation in bleeding patients and if patients cannot use blood, this will have a much bigger issue with resuscitation and this study is not designed to follow up that population.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06510
About this study
This is a prospective, randomized, double-blinded study to compare the use of albumin versus lactated Ringer's solution in patients undergoing coronary artery bypass graft surgery and in patients undergoing aortic valve replacement surgery and evaluate the incidence of acute kidney injury as a primary outcome.
Read the detailed description
This will be a prospective, randomized, double-blinded study to compare the use of albumin versus lactated Ringer's solution in patients undergoing coronary artery bypass graft surgery and in patients undergoing aortic valve replacement surgery and evaluate the incidence of acute kidney injury as a primary outcome. Data will be collected from both EPIC and STS (society of thoracic surgeons) database. STS database extracts data from the electronic medical record and groups it in specific format to evaluate outcomes after cardiac surgery to compare institutional performance to similar institutions and the national average. Patients undergoing coronary artery bypass graft or aortic valve replacement will be randomized to receive either albumin or lactated Ringer's for fluid resuscitation post-surgery. The resuscitation volume will be based on clinical decision after examining all the hemodynamics parameters. This practice coincides with standard of care and current practice. All eligible patients will be randomly assigned to receive either albumin 5% or lactated Ringer's solution in a 1:1 ratio using computer-generated, permutated blocks of 2 - 4. Both solutions will be administered intravenously in 250 mL increments at the discretion of the physician until hemodynamic parameters are met. The IV infusion bag and IV tubing will be covered using opaque bags to allow for blinding.
- Being tested
- Albumin Solution, Lactated Ringer's Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albumin SolutionOther
Participants will receive Albumin solution for fluid resuscitation post-surgery.
Lactated Ringer's SolutionOther
Participants will receive Lactated Ringer's solution for fluid resuscitation post-surgery.
| Study group | Role | What they receive |
|---|---|---|
| Albumin Solution | Experimental | Participants will receive Albumin solution for fluid resuscitation post-surgery. Receives: Other: Albumin Solution |
| Lactated Ringer's Solution | Experimental | Participants will receive lactated Ringer's for fluid resuscitation post-surgery Receives: Other: Lactated Ringer's Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Kidney Injury
Acute kidney injury will be assessed by these criteria: Stage I. Increase 1.5-1.9 times from baseline or ≥ 0.3 mg/dl increase within 48 h. Urinary output (UOP) < 0.5 ml/kg/h for 6-12 hours Stage II. Increase > 2- to 3-fold from baseline. UOP < 0.5 ml/kg/h for 12 hours Stage III. Increased > 300% (> 3-fold) from baseline, or ≥ 4.0 mg/dl with an acute increase of ≥ 0.5 mg/dl or on renal replacement therapy. UOP < 0.3 ml/kg/h for 24 hours or anuria for 12 hours
Measured: Within 72 hours post randomization
Secondary outcomes (4)
Extubation time
Duration of intubation
Measured: Up to 90 days
Length of stay in the ICU
Length of stay in the ICU
Measured: Up to 90 days
Length of stay in the hospital
Length of stay in the hospital
Measured: Up to 90 days
Hospital readmission
An episode when a patient who had been discharged from a hospital is admitted again within a specified time interval
Measured: Readmission within 30 days of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start1 Jul 2021
- Primary completion26 Jul 2022
- Study completion26 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass Graft SurgeryStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hossam Tantway, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652375
- Sponsor's protocol ID
- 2000025462
- Other IDs
- 000
- Status last verified
- Sep 2024
- First submitted
- 25 Nov 2020
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes After Albumin Vs Lactated Ringer's Solution in CABG and AVR Procedures
- ClinicalTrials.gov ID
- NCT04652375
- Acronym / sponsor ID
- 2000025462
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 26 Jul 2022 (actual)
- Study completion
- 26 Jul 2022 (actual)
- First posted
- 3 Dec 2020 (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.
This is a prospective, randomized, double-blinded study to compare the use of albumin versus lactated Ringer's solution in patients undergoing coronary artery bypass graft surgery and in patients undergoing aortic valve replacement surgery and evaluate the incidence of acute kidney injury as a primary outcome.
Detailed description
This will be a prospective, randomized, double-blinded study to compare the use of albumin versus lactated Ringer's solution in patients undergoing coronary artery bypass graft surgery and in patients undergoing aortic valve replacement surgery and evaluate the incidence of acute kidney injury as a primary outcome. Data will be collected from both EPIC and STS (society of thoracic surgeons) database. STS database extracts data from the electronic medical record and groups it in specific format to evaluate outcomes after cardiac surgery to compare institutional performance to similar institutions and the national average. Patients undergoing coronary artery bypass graft or aortic valve replacement will be randomized to receive either albumin or lactated Ringer's for fluid resuscitation post-surgery. The resuscitation volume will be based on clinical decision after examining all the hemodynamics parameters. This practice coincides with standard of care and current practice. All eligible patients will be randomly assigned to receive either albumin 5% or lactated Ringer's solution in a 1:1 ratio using computer-generated, permutated blocks of 2 - 4. Both solutions will be administered intravenously in 250 mL increments at the discretion of the physician until hemodynamic parameters are met. The IV infusion bag and IV tubing will be covered using opaque bags to allow for blinding.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Albumin Solution | Experimental | Other: Albumin SolutionParticipants will receive Albumin solution for fluid resuscitation post-surgery. |
| Lactated Ringer's Solution | Experimental | Other: Lactated Ringer's SolutionParticipants will receive lactated Ringer's for fluid resuscitation post-surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients greater than 18 years of age undergoing CABG and AVR procedures
Key exclusion criteria (3 listed)
- Low ejection fraction (<20%) End stage renal disease Chronic renal insufficiency Pre-operative Inotropic (eg. Dobutamine) or vasoactive IV infusions (e.g, norepinephrine)
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 SolutionParticipants will receive Albumin solution for fluid resuscitation post-surgery. | Other | Albumin Solution |
| Lactated Ringer's SolutionParticipants will receive Lactated Ringer's solution for fluid resuscitation post-surgery. | Other | Lactated Ringer's Solution |
Primary outcome
Acute Kidney Injury
Time frame: Within 72 hours post randomization
Acute kidney injury will be assessed by these criteria: Stage I. Increase 1.5-1.9 times from baseline or ≥ 0.3 mg/dl increase within 48 h. Urinary output (UOP) < 0.5 ml/kg/h for 6-12 hours Stage II. Increase > 2- to 3-fold from baseline. UOP < 0.5 ml/kg/h for 12 hours Stage III. Increased > 300% (> 3-fold) from baseline, or ≥ 4.0 mg/dl with an acute increase of ≥ 0.5 mg/dl or on renal replacement therapy. UOP < 0.3 ml/kg/h for 24 hours or anuria for 12 hours
4 secondary outcomes
Extubation time
Time frame: Up to 90 days
Length of stay in the ICU
Time frame: Up to 90 days
Length of stay in the hospital
Time frame: Up to 90 days
Hospital readmission
Time frame: Readmission within 30 days of discharge
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 23 Sep 2024.
- 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.
Hossam Tantway, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Albumin Solution and Lactated Ringer's Solution in people with Coronary Artery Bypass Graft Surgery and Aortic Valve Replacement, run by Yale University at 1 site in United States.
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 23 Sep 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 United States. 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?
Acute Kidney Injury (time frame: Within 72 hours post randomization). 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 23 Sep 2024.