NCT04652375

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Coronary Artery Bypass Graft Surgery
• Aortic Valve Replacement

Interventions

Type	Name	Description
OTHER	Albumin Solution	Participants will receive Albumin solution for fluid resuscitation post-surgery.
OTHER	Lactated Ringer's Solution	Participants will receive Lactated Ringer's solution for fluid resuscitation post-surgery.

Timeline

• Start date: 2021-07-01
• Primary completion: 2022-07-26
• Completion: 2022-07-26
• First posted: 2020-12-03
• Last updated: 2024-09-23

Locations

1 site across 1 country: United States