Outcomes After Albumin Vs Lactated Ringer's Solution in CABG and AVR Procedures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-07-26

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronary Artery Bypass Graft Surgery Aortic Valve Replacement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Albumin Solution

Participants will receive Albumin solution for fluid resuscitation post-surgery.

Group Type EXPERIMENTAL

Albumin Solution

Intervention Type OTHER

Participants will receive Albumin solution for fluid resuscitation post-surgery.

Lactated Ringer's Solution

Participants will receive lactated Ringer's for fluid resuscitation post-surgery

Group Type EXPERIMENTAL

Lactated Ringer's Solution

Intervention Type OTHER

Participants will receive Lactated Ringer's solution for fluid resuscitation post-surgery.

Interventions

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Albumin Solution

Participants will receive Albumin solution for fluid resuscitation post-surgery.

Intervention Type OTHER

Lactated Ringer's Solution

Participants will receive Lactated Ringer's solution for fluid resuscitation post-surgery.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All patients greater than 18 years of age undergoing CABG and AVR procedures

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No