Albumin Utilization in Adult Cardiac Surgical Patients: Retrospective

NCT06322537 | Active Not Recruiting

• 1 other identifier: 23-5339
• Study Type: observational
• Target: 505
• Locations: 1 country
• Sites: 10

Brief Summary

All heart surgery patients universally require hydration, which is given through a vein in the arm, but practices for treating patients are not universal. There are disagreements about whether crystalloids should be used alone or in combination with albumin. This question has important implications because albumin is an expensive blood product in relatively limited supply, and 20% of its use is by heart surgery patients. The goal of this study is to learn more about how crystalloids and albumin are used during heart surgery, as well as, key patient outcomes.

Conditions

Cardiovascular Surgical Procedures; Albumin

Outcome Measures

Primary Outcomes (2)

• Albumin

  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.

• Crystalloid, volume dose and type administered

  Type and volume of crystalloid given (Normal saline, Ringer's Lactate, Plasmalyte-148, 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

Adult (≥18 years old) patients who have undergone cardiac surgery.

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 up to 500 adult (≥18 years old) patients who have undergone major cardiac surgery. All adult (≥18 years old) patients who have undergone cardiac surgery (with or without the use of cardio-pulmonary bypass) will be eligible. There are no specific exclusion criteria.

You may qualify if:

• Adult (≥18 years old)
• Cardiac surgery with the use of cardiopulmonary bypass
• Cardiac surgery without the use of cardiopulmonary bypass

You may not qualify if:

• None

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Kingston Health Sciences Centre: collaborator
• Unity Health Toronto: collaborator
• McMaster University: collaborator
• Sunnybrook Health Sciences Centre: collaborator
• London Health Sciences Centre: collaborator
• The Ottawa Hospital: collaborator
• Vancouver General Hospital: collaborator
• Royal Columbian Hospital Foundation: collaborator
• Nova Scotia Health Authority: collaborator

Study Sites (10)

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Nova Scotia Health Authority

Halifax, Nova Scotia, B3H 3A6, Canada

Location

McMaster University Medical Centre

Hamilton, Ontario, Canada

Location

Kingston Health Sciences Centre

Kingston, Ontario, K7L 3N6, Canada

Location

London Health Science Centre

London, Ontario, N6A 5A5, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Toronto General Hospital - University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

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: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: March 21, 2024
• Study Start: May 23, 2024
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (10)