Acute Normovolemic Hemodilution on Urine Neutrophil Gelatinase-associated Lipocalin Levels

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT05349292
Status
Recruiting
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Conditions

  • Acute Kidney Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • ANH — OTHER
    one group will be managed with ANH and the other without (control group)

Study Details

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.

Key Dates

Start date
Jan 31, 2024
Status verified
Apr 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Acute Normovolemic Hemodilution
    Patients undergoing CABG surgery with acute normovolemic hemodilution and autologous blood donation
  • Arm: non Acute Normovolemic Hemodilution
    Patients undergoing CABG surgery without acute normovolemic hemodilution and autologous blood donation

Primary Outcome Measure

Urinary Biomarkers NGAL and KIM-1 [ Time Frame: 24 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Maryland Medical CenterBaltimoreMaryland21201
Patrick Odonkor, MD

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By research site
University of Maryland Medical Center· Baltimore, MD

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