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

NCT06395480 | Active Not Recruiting

• 1 other identifier: 23-5261
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 2

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.

Conditions

Antithrombin III Levels; Albumin Levels

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (1)

Cardiac Surgery Patients

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Kingston Health Sciences Centre: collaborator

Study Sites (2)

Kingston Health Sciences Centre

Kingston, Ontario, K7L 3N6, Canada

Location

Toronto General Hospital - University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample

Study Officials

• Keyvan Karkouti, MD MSc FRCPC

  Toronto General Hospital - University Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: May 2, 2024
• Study Start: June 11, 2024
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

CA (2)