NCT05349292 Acute Normovolemic Hemodilution on Urine Neutrophil Gelatinase-associated Lipocalin Levels
| NCT ID | NCT05349292 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Maryland, Baltimore |
| Condition | Acute Kidney Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-01-31 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-01-31 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Patrick Odonkor, MD
PRINCIPAL INVESTIGATOR
University of Maryland, Baltimore
Frequently Asked Questions
Who can join the NCT05349292 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Acute Kidney Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05349292 currently recruiting?
Yes, NCT05349292 is actively recruiting participants. Contact the research team at podonkor@som.umaryland.edu for enrollment information.
Where is the NCT05349292 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT05349292 clinical trial?
NCT05349292 is sponsored by University of Maryland, Baltimore. The principal investigator is Patrick Odonkor, MD at University of Maryland, Baltimore. The trial plans to enroll 100 participants.
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