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

Coronary Artery Bypass Graft Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04652375
• Other study ID #: 2000025462
• Secondary ID: No NIH funding
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: July 2024

Study information

• Verified date: November 2023
• Source: Yale University
• Contact: Hossam Tantawy, MD
• Phone: 203-785-2802
• Email: hossam.tantawy[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Replacement
• Coronary Artery Bypass Graft Surgery

Intervention

Other:
• Albumin Solution
Participants will receive Albumin solution for fluid resuscitation post-surgery.
• Lactated Ringer's Solution
Participants will receive Lactated Ringer's solution for fluid resuscitation post-surgery.

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Within 72 hours post randomization
Secondary	Extubation time	Duration of intubation	Up to 90 days
Secondary	Length of stay in the ICU	Length of stay in the ICU	Up to 90 days
Secondary	Length of stay in the hospital	Length of stay in the hospital	Up to 90 days
Secondary	Hospital readmission	An episode when a patient who had been discharged from a hospital is admitted again within a specified time interval	Readmission within 30 days of discharge