Clinical trial NCT06322537: Albumin Utilization in Adult Cardiac Surgical Patients: Retrospective
Official title: Albumin Utilization for Intravascular Volume Replacement in Adult Cardiac Surgical Patients : a Multi-centre, Retrospective, Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Surgical Procedures
Albumin
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Kingston Health Sciences Centre
name: Unity Health Toronto
name: McMaster University
name: Sunnybrook Health Sciences Centre
name: London Health Sciences Centre
name: The Ottawa Hospital
name: Vancouver General Hospital
name: Royal Columbian Hospital Foundation
name: Nova Scotia Health Authority
First posted: 2024-03-21
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Albumin
timeFrame: On CPB, in the operating room but not during CPB, in the ICU, on the ward to post operative day 28.
measure: Crystalloid, volume dose and type administered
timeFrame: On CPB, in the operating room but not during CPB, in the ICU, on the ward to post operative day 28.
Secondary outcomes:
Other outcomes:
Locations:
city: New Westminster
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
city: Vancouver,
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
state: Nova Scotia
city: Hamilton
country: Canada
facility: McMaster University Medical Centre
state: Ontario
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
city: London
country: Canada
facility: London Health Science Centre
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital - University Health Network
state: Ontario
Study officials:
affiliation: Toronto General Hospital - University Health Network
name: Keyvan Karkouti, MD MSc FRCPC
role: PRINCIPAL_INVESTIGATOR
References: