Cardiovascular Surgical ProceduresAlbACS-1RNCT06322537
Albumin Utilization in Adult Cardiac Surgical Patients: Retrospective
An observational study of Cardiovascular Surgical Procedures and Albumin, run by University Health Network, Toronto at 10 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cardiovascular Surgical Procedures, Albumin
- How many people
- 505 participants
- Where
- 10 sitesCanada
- Study dates
- 23 May 2024to 31 Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult (≥18 years old)
- Cardiac surgery with the use of cardiopulmonary bypass
- Cardiac surgery without the use of cardiopulmonary bypass
Who cannot join
- None
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Canada10 sites
Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 3A6
McMaster University Medical Centre
Hamilton, Ontario
Kingston Health Sciences Centre
Kingston, Ontario, K7L 3N6
London Health Science Centre
London, Ontario, N6A 5A5
Royal Columbian Hospital
New Westminster, British Columbia, V3L 3W7
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Toronto General Hospital - University Health Network
Toronto, Ontario, M5G 2C4
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: Albumin Utilization for Intravascular Volume Replacement in Adult Cardiac Surgical Patients : A Multi-centre, Retrospective, Cohort Study
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.
Read the 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.
- Conditions
- Cardiovascular Surgical Procedures, Albumin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Surgery Patients | Adult (≥18 years old) patients who have undergone cardiac surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: On CPB, in the operating room but not during CPB, in the ICU, on the ward to post operative day 28.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start23 May 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Surgical ProceduresStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 505 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Kingston Health Sciences Centre, Unity Health Toronto, McMaster University, Sunnybrook Health Sciences Centre, London Health Sciences Centre, The Ottawa Hospital, Vancouver General Hospital, Royal Columbian Hospital Foundation, Nova Scotia Health Authority
- Responsible party
- Sponsor
- Investigators
- Keyvan Karkouti, MD MSc FRCPC, Principal investigator, Toronto General Hospital - University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322537
- Sponsor's protocol ID
- 23-5339
- Acronym
- AlbACS-1R
- Status last verified
- Jun 2026
- First submitted
- 21 Feb 2024
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No