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

Not Applicable

Recruiting

• Conditions: Coronary Artery Bypass Graft Surgery; Aortic Valve Replacement
• Interventions: Other: Lactated Ringer's Solution; Other: Albumin Solution

• Registration Number: NCT04652375
• Lead Sponsor: Yale University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-11-25
• Study First Submitted QC: 2020-11-26
• Study First Posted: 2020-12-03
• Study Start: 2021-07-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-27
• Primary Completion: 2024-07
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactated Ringer's Solution	Lactated Ringer's Solution	Participants will receive lactated Ringer's for fluid resuscitation post-surgery
Albumin Solution	Albumin Solution	Participants will receive Albumin solution for fluid resuscitation post-surgery.

Primary Outcome Measures

Name	Time	Method
Acute Kidney Injury	Within 72 hours post randomization	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

Secondary Outcome Measures

Name	Time	Method
Length of stay in the hospital	Up to 90 days	Length of stay in the hospital
Extubation time	Up to 90 days	Duration of intubation
Length of stay in the ICU	Up to 90 days	Length of stay in the ICU
Hospital readmission	Readmission within 30 days of discharge	An episode when a patient who had been discharged from a hospital is admitted again within a specified time interval

Trial Locations

Locations (1)

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States