Acute Normovolemic Hemodilution on Urine Neutrophil Gelatinase-associated Lipocalin Levels

NCT05349292 | Recruiting

• 1 other identifier: HP-00099231
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• AKI by KDIGO criteria

  72 hours

Study Arms (2)

Acute Normovolemic Hemodilution

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

Other: ANH

non Acute Normovolemic Hemodilution

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

Interventions

ANH OTHER

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

Acute Normovolemic Hemodilution

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 26579641 RESULT

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Patrick Odonkor, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Odonkor, MD

CONTACT

4103286120; podonkor@som.umaryland.edu

Brittney Williams, MD

CONTACT

4103286120; brittney.williams@som.umaryland.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: April 27, 2022
• Study Start: January 31, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)