Clinical trial NCT06395480: Albumin Utilization in Adult Cardiac Surgical Patients : a Multicentre Prospective Cohort Study
Official title: Albumin Utilization for Intravascular Volume Replacement in Adult Cardiac Surgical Patients : a Multicentre Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Antithrombin III Levels
Albumin Levels
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Kingston Health Sciences Centre
First posted: 2024-05-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Albumin (g/L)
timeFrame: On CPB, in the operating room but not during CPB, in the ICU, on the ward to post operative day 28
measure: Antithrombin III (g/L)
timeFrame: On CPB, in the operating room but not during CPB, in the ICU, on the ward to post operative day 28
measure: Crystalloid
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: Kingston
country: Canada
facility: Kingston Health Sciences Centre
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: