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

NCT04652375 | Completed DMC

• 2 other identifiers: 2000025462000
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Bypass Graft Surgery; Aortic Valve Replacement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Extubation time

  Up to 90 days

• Length of stay in the ICU

  Up to 90 days

• Length of stay in the hospital

  Up to 90 days

• Hospital readmission

  Readmission within 30 days of discharge

Study Arms (2)

Albumin Solution

EXPERIMENTAL

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

Other: Albumin Solution

Lactated Ringer's Solution

EXPERIMENTAL

Participants will receive lactated Ringer's for fluid resuscitation post-surgery

Other: Lactated Ringer's Solution

Interventions

Albumin Solution OTHER

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

Albumin Solution

Lactated Ringer's Solution OTHER

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

Lactated Ringer's Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Interventions

Ringer's Lactate

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Hossam Tantway, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: December 3, 2020
• Study Start: July 1, 2021
• Primary Completion: July 26, 2022
• Study Completion: July 26, 2022
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)