Effect of Low-volume Fluid Replacement Strategy During Acute Normovolemic Hemodilution on Urine Neutrophil Gelatinase-associated Lipocalin Levels: an Acute Kidney Injury Biomarker

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
View:

• 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

Locations
United States
Maryland
University of Maryland Medical Center
RECRUITING
Baltimore
Contact Information
Primary
Patrick Odonkor, MD
podonkor@som.umaryland.edu
4103286120
Backup
Brittney Williams, MD
brittney.williams@som.umaryland.edu
4103286120
Time Frame
Start Date: 2024-01-31
Estimated Completion Date: 2027-06
Participants
Target number of participants: 100
Treatments
Acute Normovolemic Hemodilution
Patients undergoing CABG surgery with acute normovolemic hemodilution and autologous blood donation
non Acute Normovolemic Hemodilution
Patients undergoing CABG surgery without acute normovolemic hemodilution and autologous blood donation
Related Therapeutic Areas
Sponsors
Leads: University of Maryland, Baltimore

This content was sourced from clinicaltrials.gov