Albumin Utilization in Adult Cardiac Surgical Patients: Retrospective

NCT ID: NCT06322537

Last Updated: 2025-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

505 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-23

Study Completion Date

2026-01-01

Brief Summary

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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.

Detailed Description

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The goal of this proposed multicentre retrospective cohort study is to characterize perioperative usage patterns of crystalloids and albumin, as well as key patient outcomes, in 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.

The primary objective is to obtain granular information on if, when, and how albumin is given perioperatively to cardiac surgical patients. This includes the doses and settings in which albumin is used, the types of crystalloid solutions (balanced or unbalanced) used, and when albumin is used (for example, while on cardio-pulmonary bypass, in the ICU, or on the ward) in perioperative cardiac surgical care across institutions. This important information about the scope of albumin and crystalloid use across the country will inform the design of our future intervention and control arms in the planned definitive trial.

Conditions

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Cardiovascular Surgical Procedures Albumin

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cardiac Surgery Patients

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Kingston Health Sciences Centre

OTHER

Sponsor Role collaborator

Unity Health Toronto

OTHER

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role collaborator

London Health Sciences Centre

OTHER

Sponsor Role collaborator

The Ottawa Hospital

OTHER

Sponsor Role collaborator

Vancouver General Hospital

OTHER

Sponsor Role collaborator

Royal Columbian Hospital Foundation

OTHER

Sponsor Role collaborator

Nova Scotia Health Authority

OTHER

Sponsor Role collaborator

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Keyvan Karkouti, MD MSc FRCPC

Role: PRINCIPAL_INVESTIGATOR

Toronto General Hospital - University Health Network

Locations

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Royal Columbian Hospital

New Westminster, British Columbia, Canada

Site Status

Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status

Nova Scotia Health Authority

Halifax, Nova Scotia, Canada

Site Status

McMaster University Medical Centre

Hamilton, Ontario, Canada

Site Status

Kingston Health Sciences Centre

Kingston, Ontario, Canada

Site Status

London Health Science Centre

London, Ontario, Canada

Site Status

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Site Status

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

St. Michael's Hospital

Toronto, Ontario, Canada

Site Status

Toronto General Hospital - University Health Network

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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23-5339

Identifier Type: -

Identifier Source: org_study_id

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