Acute Normovolemic Hemodilution on Urine Neutrophil Gelatinase-associated Lipocalin Levels
University of Maryland, Baltimore · NCT05349292
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–70 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Observational
- Target enrollment
- 100
- US sites recruiting
- 1
- Study start
- January 31, 2024
- Record last updated
- May 1, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
Acute normovolemic hemodilution (ANH) is performed as a blood conservation technique during surgical procedures with high risk for significant blood loss. It is done by taking out some of the patients blood before surgery actually begins and storing this blood inside of the operating room and giving it back to the patient at the end of surgery when most of the expected surgical bleeding has already occurred. This practice reduces the amount of bleeding that occurs after surgery and also reduces the amount of blood transfusions given to the patient after surgery. Transfusion of blood products from the blood bank may cause problems such as transfusion reactions and infections like hepatitis, and also increases cost.
3 meta-analyses and several smaller trials have shown improvement in blood transfusion rates with the use of ANH, however there is no evidence of improvement in other complication rates, morbidity and mortality, length of stay or cost.
In most types of surgery, when ANH is done, large volumes of IV fluids are given to the patient to prevent a drop in circulatory volume and blood pressure. However during heart surgery, this can cause significant levels of hemodilution in addition to that caused by use of the heart-lung machine. In order to minimize hemodilution when ANH is performed during heart surgery, a smaller amount of IV fluids are given to the patient after blood is drawn. Vasoactive medications are then administered to prevent the blood pressure from dropping.
Kidney injury is a recognized complication that may occur after heart surgery. It may be caused by low blood volume, low blood pressure and anemia. It is not known whether performance of ANH and use of the heart-lung machine may increase risk for kidney injury. Kidney injury is associated with increased risk for other medical complications and death. This increased risk for kidney injury arising from ANH has not been evaluated. This study will therefore compare patients treated with ANH to those not treated with ANH to determine whether there is an increased risk for kidney injury with the use of ANH.
Being studied: ANH
Conditions: Acute Kidney Injury
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Recruiting US locations
University of Maryland Medical Center
Baltimore, MD 21201
Site contact: Patrick Odonkor, MD
Study contacts (from the official record)
- Patrick Odonkor, MD · 4103286120 · podonkor@som.umaryland.edu
- Brittney Williams, MD · 4103286120 · brittney.williams@som.umaryland.edu
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