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

Recruiting

• Conditions: Antithrombin III Levels; Albumin Levels

• Registration Number: NCT06395480
• Lead Sponsor: University Health Network, Toronto

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-02-21
• Study First Submitted QC: 2024-04-29
• Study First Posted: 2024-05-02
• Study Start: 2024-05-23
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-10
• Primary Completion: 2025-11-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Albumin (g/L)	On CPB, in the operating room but not during CPB, in the ICU, on the ward to post operative day 28	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).
Antithrombin III (g/L)	On CPB, in the operating room but not during CPB, in the ICU, on the ward to post operative day 28	Measured in g/L
Crystalloid	On CPB, in the operating room but not during CPB, in the ICU, on the ward to post operative day 28.	and others), as well as the setting of administration will be recorded.

Trial Locations

Locations (2)

Kingston Health Sciences Centre; 🇨🇦 Kingston, Ontario, Canada

Toronto General Hospital - University Health Network; 🇨🇦 Toronto, Ontario, Canada