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

Yale University

Status: Completed

Conditions: Coronary Artery Bypass Graft Surgery; Aortic Valve Replacement

Treatments: Other: Lactated Ringer's Solution; Other: Albumin Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT04652375

000

2000025462

Details and patient eligibility

About

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.

Full 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.

Enrollment: 131 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

131 participants in 2 patient groups

Albumin Solution

Experimental group

Description:

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

Treatment:

Other: Albumin Solution

Lactated Ringer's Solution

Experimental group

Description:

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

Treatment:

Other: Lactated Ringer's Solution