Recruiting

Acute Normovolemic Hemodilution

Sponsor:

University of Maryland, Baltimore

Code:

NCT05349292

Conditions

Acute Kidney Injury

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

ANH

Study Details

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.

Conditions

Acute Kidney Injury

Study ID

NCT05349292

Start date

Jan 31, 2024

Status verified date

Apr, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

ANH

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

University of Maryland Medical Center

Recruiting

Baltimore, Maryland, United States, 21201

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

May 1, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-05-01.