Albumin Utilization in Adult Cardiac Surgical Patients : A Multicentre Prospective Cohort Study (AlbACS-1Pro)

Albumin Utilization for Intravascular Volume Replacement in Adult Cardiac Surgical Patients : A Multicentre Prospective Cohort Study

The goal of our proposed multicentre prospective cohort study is to characterize perioperative usage patterns of crystalloids and albumin, as well as key patient outcomes, in cardiac surgical patients. Results obtained from this observational study will be combined with the results of other studies to clarify the optimal role of albumin and other blood products in the perioperative management of cardiac surgical patients. This study will also address numerous other knowledge gaps in the area of perioperative blood product management and fluid administration in cardiac surgery and define a collaborative group to support future research in this field.

Study Overview

• Status: Not yet recruiting
• Conditions: Antithrombin III Levels; Albumin Levels

Detailed Description

This is a prospective observational study of 100 patients undergoing cardiac surgery, with a target of 50 participants per site. There is a clear need for a large-scale, multicentre, randomized trial to determine the role of albumin in cardiac surgical patients, particularly in higher risk cohorts such as patients with poor ventricular function and those undergoing complex procedures. A major obstacle to conducting this trial is a lack of data regarding perioperative albumin prescribing across providers and centres, including the indication for use, timing, formulation, and dose used in different settings (i.e., in the operating room, in the intensive care unit, and on the ward). Additionally, there is little data describing variability in typical resuscitation practices, and whether centre-level differences are associated with patient outcomes. This information is critical to inform trial design, including clinically relevant trial arms and endpoints. Thus, the goal of the proposed research is to obtain information on albumin use in cardiac surgical patients across Canada that will contribute to the design of a definitive randomized controlled trial in this population.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Justyna Bartoszko, MD MSc FRCPC; Phone Number: 5164 416-340-4800; Email: actu@uhn.ca

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 3N6
      • Kingston Health Sciences Centre
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto General Hospital - University Health Network
      • Contact: Justyna Bartoszko, MD MSc FRCPC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study will include 100 adult (≥18 years old) patients who are undergoing major cardiac surgery. All adult (≥18 years old) patients who are undergone cardiac surgery (with or without the use of cardio-pulmonary bypass) will be eligible. There are no specific exclusion criteria, except lack of consent.

Description

Inclusion Criteria:

• All adult (≥18 years old) patients undergoing cardiac surgery (with or without the use of cardiopulmonary bypass) will be eligible.

Exclusion Criteria:

• Patients who are unable to consent to the study or who refuse participation will be excluded.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cardiac Surgery Patients; All consenting adults undergoing cardiac surgery at Toronto General Hospital and Kingston Health Sciences Centre.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Albumin (g/L)	Type, dose and timing of administration, the setting in which it was ordered, indication for use, and the type of provider responsible for the patient at administration (surgeon, anesthesiologist, intensivist, nurse practitioner).	On CPB, in the operating room but not during CPB, in the ICU, on the ward to post operative day 28
Antithrombin III (g/L)	Measured in g/L	On CPB, in the operating room but not during CPB, in the ICU, on the ward to post operative day 28
Crystalloid	and others), as well as the setting of administration will be recorded.	On CPB, in the operating room but not during CPB, in the ICU, on the ward to post operative day 28.

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Queen's University
• Investigators: Principal Investigator: Keyvan Karkouti, MD MSc FRCPC, Toronto General Hospital - University Health Network

Study record dates

Study Major Dates

• Study Start (Estimated): May 2, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: April 29, 2024
• First Posted (Estimated): May 2, 2024

Study Record Updates

• Last Update Posted (Estimated): May 2, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 23-5261

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No