Acute Normovolemic Hemodilution on Urine Neutrophil Gelatinase-associated Lipocalin Levels

NCT ID: NCT05349292

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2027-06-30

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.

Detailed Description

The study population will consist of 50 adult patients less than 70 years old undergoing elective coronary artery bypass graft (CABG) surgery with anticipated CPB duration less than 2 hours at the University of Maryland Medical Center (UMMC). Patients less than 70kg in weight and patients with renal insufficiency and/or hemoglobin levels less than 12g/dL will be excluded. We shall also exclude patients with heart failure (EF <40%) and any significant hepatic or pulmonary comorbidities, including pulmonary hypertension. Patients undergoing emergency and redo cardiac surgery and those with inherited or acquired bleeding disorders will also be excluded.

This study will be a non-blinded randomized prospective observational study. Due to the nature of the intervention being evaluated, blinding will not be achievable. We shall randomly divide patients into 2 groups, where one group will be managed with ANH and the other without (control group). Patients managed with ANH will have 12cc/kg of blood salvaged and stored at room temperature prior to CPB. The stored blood will then be administered to the patient after CPB. Intravascular volume will be replenished in a 1:1 ratio with balanced crystalloid solution during blood salvage. The other group of patients will receive an empiric 7cc/kg bolus of intravenous balanced crystalloid solution prior to CPB. On average, crystalloid infusions are limited to about 500cc prior to CPB to minimize hemodilution of blood.

Patients will otherwise be managed according to normal protocols and pathways used in the perioperative management of CS patients at UMMC.

Conditions

Acute Kidney Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Acute Normovolemic Hemodilution

Patients undergoing CABG surgery with acute normovolemic hemodilution and autologous blood donation

ANH

Intervention Type: OTHER

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

non Acute Normovolemic Hemodilution

Patients undergoing CABG surgery without acute normovolemic hemodilution and autologous blood donation

No interventions assigned to this group

Interventions

ANH

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Patrick Odonkor

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patrick Odonkor, MD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Locations

University of Maryland Medical Center

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Patrick Odonkor, MD

Role: CONTACT

podonkor@som.umaryland.edu

4103286120

Brittney Williams, MD

Role: CONTACT

brittney.williams@som.umaryland.edu

4103286120

Facility Contacts

Patrick Odonkor, MD

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 26579641 (View on PubMed)

Other Identifiers

HP-00099231

Identifier Type: -

Identifier Source: org_study_id