Albumin Utilization in Adult Cardiac Surgical Patients: Retrospective

Cardiovascular Surgical Procedures Clinical Trial

— AlbACS-1R  

Official title:

Albumin Utilization for Intravascular Volume Replacement in Adult Cardiac Surgical Patients : A Multi-centre, Retrospective, Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06322537
• Other study ID #: 23-5339
• Status: Not yet recruiting
• Start date: April 2, 2024
• Est. completion date: November 1, 2025

Study information

• Verified date: February 2024
• Source: University Health Network, Toronto
• Contact: Justyna Bartoszko, MD MSc FRCPC
• Phone: 416-340-4800
• Email: actu[@]uhn.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Surgical Procedures

Locations

Country	Name	City	State
Canada	Nova Scotia Health Authority	Halifax	Nova Scotia
Canada	McMaster University Medical Centre	Hamilton	Ontario
Canada	Kingston Health Sciences Centre	Kingston	Ontario
Canada	London Health Science Centre	London	Ontario
Canada	Royal Columbian Hospital	New Westminster	British Columbia
Canada	University of Ottawa Heart Institute	Ottawa	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Toronto General Hospital - University Health Network	Toronto	Ontario
Canada	Vancouver General Hospital	Vancouver,	British Columbia

Sponsors (10)

Lead Sponsor	Collaborator
University Health Network, Toronto	London Health Sciences Centre, McMaster University, Nova Scotia Health Authority, Queen's University, Royal Columbian Hospital, Sunnybrook Health Sciences Centre, The Ottawa Hospital, Unity Health Toronto, Vancouver General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.