Acute Kidney Injury Clinical Trial
Official title:
Effect of Low-volume Fluid Replacement Strategy During Acute Normovolemic Hemodilution on Urine Neutrophil Gelatinase-associated Lipocalin Levels: an Acute Kidney Injury Biomarker
NCT number | NCT05349292 |
Other study ID # | HP-00099231 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 31, 2024 |
Est. completion date | December 2025 |
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 2025 |
Est. primary completion date | June 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Maryland Medical Center | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
University of Maryland, Baltimore |
United States,
Grant MC, Resar LM, Frank SM. The Efficacy and Utility of Acute Normovolemic Hemodilution. Anesth Analg. 2015 Dec;121(6):1412-4. doi: 10.1213/ANE.0000000000000935. No abstract available. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Urinary Biomarkers NGAL and KIM-1 | Urinary levels of NGAL and KIM-1 biomarkers during the first 24 hours after CABG surgery | 24 hours | |
Secondary | AKI by KDIGO criteria | Creatinine values and urine output for 3 days after CS will be recorded for calculation of AKI by KDIGO criteria. | 72 hours |
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