Acute Kidney InjuryNCT05349292
Acute Normovolemic Hemodilution on Urine Neutrophil Gelatinase-associated Lipocalin Levels
An observational study of Acute Kidney Injury, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- ANH
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2024to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Maryland Medical Center
Baltimore, Maryland, 21201
Patrick Odonkor, MD
About this study
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
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.
Read more
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.
Read the 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
- Being tested
- ANH
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANHOther
one group will be managed with ANH and the other without (control group)
| Study group | Role | What they receive |
|---|---|---|
| Acute Normovolemic Hemodilution | Patients undergoing CABG surgery with acute normovolemic hemodilution and autologous blood donation Receives: Other: ANH | |
| non Acute Normovolemic Hemodilution | Patients undergoing CABG surgery without acute normovolemic hemodilution and autologous blood donation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Biomarkers NGAL and KIM-1
Urinary levels of NGAL and KIM-1 biomarkers during the first 24 hours after CABG surgery
Measured: 24 hours
Secondary outcomes (1)
AKI by KDIGO criteria
Creatinine values and urine output for 3 days after CS will be recorded for calculation of AKI by KDIGO criteria.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start31 Jan 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Odonkor, University of Maryland, Baltimore
- Investigators
- Patrick Odonkor, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05349292
- Sponsor's protocol ID
- HP-00099231
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2022
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26579641
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05349292
- Acronym / sponsor ID
- HP-00099231
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute Normovolemic Hemodilution | – | Other: ANHPatients 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANHone group will be managed with ANH and the other without (control group) | Other | Acute Normovolemic Hemodilution |
Primary outcome
Urinary Biomarkers NGAL and KIM-1
Time frame: 24 hours
Urinary levels of NGAL and KIM-1 biomarkers during the first 24 hours after CABG surgery
1 secondary outcome
AKI by KDIGO criteria
Time frame: 72 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Results publication: PubMed 26579641Grant 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.
- Individual participant dataSharing planned: No
Related trials for Acute Kidney Injury
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Acute Kidney Injury, Hypotension (MeSH: D007022)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrick Odonkor, MD principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick Odonkor, MD (4103286120, podonkor@som.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary Biomarkers NGAL and KIM-1 (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05349292, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.