Clinical trial NCT04652375: Outcomes After Albumin Vs Lactated Ringer's Solution in CABG and AVR Procedures
Official title: Outcomes After Albumin Vs Lactated Ringer's Solution in CABG and AVR Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Bypass Graft Surgery
Aortic Valve Replacement
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Acute Kidney Injury
timeFrame: Within 72 hours post randomization
Secondary outcomes:
measure: Extubation time
timeFrame: Up to 90 days
measure: Length of stay in the ICU
timeFrame: Up to 90 days
measure: Length of stay in the hospital
timeFrame: Up to 90 days
measure: Hospital readmission
timeFrame: Readmission within 30 days of discharge
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Hossam Tantway, MD
role: PRINCIPAL_INVESTIGATOR
References: