Albumin Utilization in Adult Cardiac Surgical Patients : A Multicentre Prospective Cohort Study

NCT ID: NCT06395480

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 104 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-11
• Study Completion Date: 2026-01-01

Brief Summary

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.

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.

Conditions

Antithrombin III Levels; Albumin Levels

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cardiac Surgery Patients

All consenting adults undergoing cardiac surgery at Toronto General Hospital and Kingston Health Sciences Centre.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Kingston Health Sciences Centre

OTHER

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Keyvan Karkouti, MD MSc FRCPC

Role: PRINCIPAL_INVESTIGATOR

Toronto General Hospital - University Health Network

Locations

Kingston Health Sciences Centre

Kingston, Ontario, Canada

Toronto General Hospital - University Health Network

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

23-5261

Identifier Type: -

Identifier Source: org_study_id