Albumin Utilization in Adult Cardiac Surgical Patients: Retrospective

Recruiting

• Conditions: Cardiovascular Surgical Procedures; Albumin

• Registration Number: NCT06322537
• Lead Sponsor: University Health Network, Toronto

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.

Study Timeline

• Study First Submitted: 2024-02-21
• Study First Submitted QC: 2024-03-19
• Study First Posted: 2024-03-21
• Study Start: 2024-05-23
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-17
• Primary Completion: 2025-11-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Albumin	On CPB, in the operating room but not during CPB, in the ICU, on the ward to post operative day 28.	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).
Crystalloid, volume dose and type administered	On CPB, in the operating room but not during CPB, in the ICU, on the ward to post operative day 28.	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.

Trial Locations

Locations (10)

Royal Columbian Hospital; 🇨🇦 New Westminster, British Columbia, Canada

Vancouver General Hospital; 🇨🇦 Vancouver,, British Columbia, 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

University of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

Toronto General Hospital - University Health Network; 🇨🇦 Toronto, Ontario, Canada