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Completed

NCT Number: NCT04652375

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Albumin Solution

Other

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

Lactated Ringer's solution

Other

Participants will receive Lactated Ringer's solution for fluid resuscitation post-surgery.

Primary outcomes

  1. Acute Kidney Injury

    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

Secondary outcomes

  1. Extubation time

    Time frame: Up to 90 days

    Duration of intubation

  2. Length of stay in the ICU

    Time frame: Up to 90 days

    Length of stay in the ICU

  3. Length of stay in the hospital

    Time frame: Up to 90 days

    Length of stay in the hospital

  4. Hospital readmission

    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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 3, 2020
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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