The Efficacy and Utility of Acute Normovolemic Hemodilution.
Michael C Grant, Linda M S Resar, Steven M Frank
https://pubmed.ncbi.nlm.nih.gov/26579641Actively Recruiting
Age: 18Years - 70Years
All Genders
Healthy Volunteers
ID05349292
Effect of Low-volume Fluid Replacement Strategy During Acute Normovolemic Hemodilution on Urine Neutrophil Gelatinase-associated Lipocalin Levels as an Acute Kidney Injury Biomarker
Led by University of Maryland, Baltimore · Updated on 2026-05-01
100
Participants Needed
1
Research Sites
26 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are investigating the use of acute normovolemic hemodilution (ANH) during elective coronary artery bypass graft (CABG) surgery to evaluate its effect on kidney injury risk. ANH is a blood conservation technique where some blood is removed before surgery and given back after, aiming to reduce blood transfusions and related complications. The study focuses on adult patients under 70 years old undergoing CABG with anticipated cardiopulmonary bypass (CPB) under two hours. The study randomly assigns participants to two groups: one managed with ANH involving blood removal at 12cc/kg and volume replacement with balanced crystalloid solution, and the other managed without ANH receiving a 7cc/kg bolus of balanced crystalloid before CPB. Blood removed in the ANH group is stored at room temperature during surgery and returned after CPB. Both groups receive standard perioperative management following hospital protocols. Participants will be monitored for urinary biomarkers NGAL and KIM-1 within 24 hours as primary outcomes to assess kidney injury, with secondary outcomes including acute kidney injury defined by KDIGO criteria within 72 hours. The study excludes patients with significant kidney, heart, liver, lung conditions, or bleeding disorders, weighing less than 70kg or with low hemoglobin. The total study duration and follow-up are aligned with perioperative and early postoperative periods to evaluate kidney injury risks related to ANH.
CONDITIONS
Brief Title
Acute Normovolemic Hemodilution on Urine Neutrophil Gelatinase-associated Lipocalin Levels
Who Can Participate
Age: 18Years - 70Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Elective Coronary Artery Bypass Graft Surgery
- Age 18-70 years
- Anticipated Cardiopulmonary Bypass Duration less than 2 hours
- Weight greater than 70kg
- Hemoglobin greater than 12 g/dL
You will not qualify if you...
- Emergency and redo cardiac surgery
- Renal insufficiency with serum creatinine greater than 1.25 mg/dL and/or estimated GFR less than 60 mL/min/1.73 m2
- Heart Failure with EF <40%
- Hepatic disease
- Pulmonary Disease, including pulmonary hypertension
- Inherited or Acquired Bleeding Disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Surgery day plus immediate recovery period
Participants undergo elective coronary artery bypass graft surgery with or without acute normovolemic hemodilution as part of their perioperative management.
1 surgical visit and immediate post-operative monitoring
Post-operative Follow-up
Duration - Up to 3 days after surgery
Participants are monitored for acute kidney injury biomarkers and recovery following surgery.
Visits within 24 to 72 hours post-surgery for biomarker measurements
Trial Site Locations
Total: 1 location
1
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
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Research Team
P
Patrick Odonkor, MD
B
Brittney Williams, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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