NCT06395480

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 104 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2024-06-11
• Primary completion: 2025-12-01
• Completion: 2026-01-01
• First posted: 2024-05-02
• Last updated: 2025-11-26

Locations

2 sites across 1 country: Canada