Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
NCT Number: NCT04652375
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.
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All sexes
Interventional
Not applicable
New Haven, Connecticut, 06510, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive Albumin solution for fluid resuscitation post-surgery.
Participants will receive Lactated Ringer's solution for fluid resuscitation post-surgery.
Time frame: 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
Time frame: Up to 90 days
Duration of intubation
Time frame: Up to 90 days
Length of stay in the ICU
Time frame: Up to 90 days
Length of stay in the hospital
Time frame: 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
Yale University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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