Renal InjuryBE-KINDNCT06109714
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
A study testing Goal Directed Fluid Therapy in people with Renal Injury and Acute Kidney Injury, run by University of Maryland, Baltimore.
Trial summary
This study is to assess the benefits of goal-directed fluid management with ACUMEN in cardiac surgical patients and its impact on cardiac surgery-induced kidney injury. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Injury, Acute Kidney Injury
- What is being tested?
- Goal Directed Fluid Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 25 Jan 2027to 31 Dec 2032
- Phase
- Interventional
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients undergoing cardiopulmonary bypass
- Procedure coronary artery bypass grafting, aortic valve replacement, or both
Who cannot join
- Patients < 18 years old
- Emergent surgery
- Preoperative kidney disease (Cr > 2.0 or on renal replacement therapy)
- Ejection fraction < 40%
- Incomplete data in medical record
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study is to assess the benefits of goal-directed fluid management with ACUMEN in cardiac surgical patients and its impact on cardiac surgery-induced kidney injury.
Read the detailed description
This study is to assess the benefits of goal-directed fluid management with ACUMEN in cardiac surgical patients undergoing a CABG, AVR, or CABG/AVR. Kidney injury biomarkers NGAL, Uromodulin, and Hepcidin-25 will be used to assess cardiac-induced kidney injury. Patients will be randomly enrolled in either standard care for fluid management or goal-directed fluid management with ACUMEN.
- Conditions
- Renal Injury, Acute Kidney Injury
- Being tested
- Goal Directed Fluid Therapy
- Keywords
- Cardiac Surgery, Cardiac Surgery Induced Kidney Injury, Kidney Biomarkers
- 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.
Goal Directed Fluid TherapyOther
Fluid administration and hemodynamic management guided with the assistance of Edwards Lifesciences ACUMEN monitor
| Study group | Role | What they receive |
|---|---|---|
| ACUMEN guided resuscitation protocol | Experimental | Fluid resuscitation and hemodynamic management will be guided by ACUMEN based off a protocol. Receives: Other: Goal Directed Fluid Therapy |
| Standard of care resuscitation | No intervention | Fluid resuscitation will be guided by standard monitors (urine output, blood loss, transesophageal echocardiography). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Kidney Injury
KIDIGO Criteria for AKI
Measured: 7 days or discharge whichever occurs first
Renal Biomarkers
NGAL, Hepcidin-25, and Uromodulin
Measured: 48 hours postoperatively
Secondary outcomes (5)
Total Fluid Administered
intraoperative and postoperative volume given measured in milliliters
Measured: From initiation of surgery to 48 hours postoperatively
ICU Length of Stay
Quantified in days and hours
Measured: From admission to the intensive care unit until discharge or 20 weeks whichever comes first.
Hemodynamic Support Usage
Vasopressor or Inotrope usage
Measured: During the first 48 hours postoperatively
Morbidity and Mortality
Death and Major adverse events (cerebral vascular stroke, myocardial infarction, infection, prolonged intubation > 24 hours)
Measured: 30 days
Blood Transfusions
Any Allogeneic Blood Transfusions
Measured: From surgical incision to 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start25 Jan 2027 (estimated)
- Primary completion1 Apr 2030 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Renal 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reney Henderson, University of Maryland, Baltimore
- Investigators
- Reney A Henderson, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06109714
- Sponsor's protocol ID
- HP-00100950
- Acronym
- BE-KIND
- Status last verified
- Nov 2026
- First submitted
- 1 Jun 2022
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kullmar M, Massoth C, Ostermann M, Campos S, Grau Novellas N, Thomson G, Haffner M, Arndt C, Wulf H, Irqsusi M, Monaco F, Di Prima A, Garcia Alvarez M, Italiano S, Cegarra SanMartin V, Kunst G, Nair S, L'Acqua C, Hoste EAJ, Vandenberghe W, Honore PM, Kellum J, Forni L, Grieshaber P, Weiss R, Gerss J, Wempe C, Meersch M, Zarbock A. Biomarker-guided implementation of the KDIGO guidelines to reduce the occurrence of acute kidney injury in patients after cardiac surgery (PrevAKI-multicentre): protocol for a multicentre, observational study followed by randomised controlled feasibility trial. BMJ Open. 2020 Apr 6;10(4):e034201. doi: 10.1136/bmjopen-2019-034201.
PubMed 32265240Vives M, Hernandez A, Parramon F, Estanyol N, Pardina B, Munoz A, Alvarez P, Hernandez C. Acute kidney injury after cardiac surgery: prevalence, impact and management challenges. Int J Nephrol Renovasc Dis. 2019 Jul 2;12:153-166. doi: 10.2147/IJNRD.S167477. eCollection 2019.
PubMed 31303781Van den Eynde J, Schuermans A, Verbakel JY, Gewillig M, Kutty S, Allegaert K, Mekahli D. Biomarkers of acute kidney injury after pediatric cardiac surgery: a meta-analysis of diagnostic test accuracy. Eur J Pediatr. 2022 May;181(5):1909-1921. doi: 10.1007/s00431-022-04380-4. Epub 2022 Jan 17.
PubMed 35039910Nadim MK, Forni LG, Bihorac A, Hobson C, Koyner JL, Shaw A, Arnaoutakis GJ, Ding X, Engelman DT, Gasparovic H, Gasparovic V, Herzog CA, Kashani K, Katz N, Liu KD, Mehta RL, Ostermann M, Pannu N, Pickkers P, Price S, Ricci Z, Rich JB, Sajja LR, Weaver FA, Zarbock A, Ronco C, Kellum JA. Cardiac and Vascular Surgery-Associated Acute Kidney Injury: The 20th International Consensus Conference of the ADQI (Acute Disease Quality Initiative) Group. J Am Heart Assoc. 2018 Jun 1;7(11):e008834. doi: 10.1161/JAHA.118.008834. No abstract available.
PubMed 29858368
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06109714
- Acronym / sponsor ID
- BE-KIND / HP-00100950
- Conditions
- Renal Injury, Acute Kidney Injury
- Keywords
- Cardiac Surgery, Cardiac Surgery Induced Kidney Injury, Kidney Biomarkers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 25 Jan 2027 (estimated)
- Primary completion
- 1 Apr 2030 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 31 Oct 2023 (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.
This study is to assess the benefits of goal-directed fluid management with ACUMEN in cardiac surgical patients and its impact on cardiac surgery-induced kidney injury.
Detailed description
This study is to assess the benefits of goal-directed fluid management with ACUMEN in cardiac surgical patients undergoing a CABG, AVR, or CABG/AVR. Kidney injury biomarkers NGAL, Uromodulin, and Hepcidin-25 will be used to assess cardiac-induced kidney injury. Patients will be randomly enrolled in either standard care for fluid management or goal-directed fluid management with ACUMEN.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACUMEN guided resuscitation protocol | Experimental | Other: Goal Directed Fluid TherapyFluid resuscitation and hemodynamic management will be guided by ACUMEN based off a protocol. |
| Standard of care resuscitation | No intervention | –Fluid resuscitation will be guided by standard monitors (urine output, blood loss, transesophageal echocardiography). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients undergoing cardiopulmonary bypass
- Procedure coronary artery bypass grafting, aortic valve replacement, or both
Key exclusion criteria (5 listed)
- Patients < 18 years old
- Emergent surgery
- Preoperative kidney disease (Cr > 2.0 or on renal replacement therapy)
- Ejection fraction < 40%
- Incomplete data in medical record
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 |
|---|---|---|
| Goal Directed Fluid TherapyFluid administration and hemodynamic management guided with the assistance of Edwards Lifesciences ACUMEN monitor | Other | ACUMEN guided resuscitation protocol |
Primary outcome
Acute Kidney Injury
Time frame: 7 days or discharge whichever occurs first
KIDIGO Criteria for AKI
Renal Biomarkers
Time frame: 48 hours postoperatively
NGAL, Hepcidin-25, and Uromodulin
5 secondary outcomes
Total Fluid Administered
Time frame: From initiation of surgery to 48 hours postoperatively
ICU Length of Stay
Time frame: From admission to the intensive care unit until discharge or 20 weeks whichever comes first.
Hemodynamic Support Usage
Time frame: During the first 48 hours postoperatively
Morbidity and Mortality
Time frame: 30 days
Blood Transfusions
Time frame: From surgical incision to 48 hours postoperatively
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 5 Nov 2026.
- Background: PubMed 32265240Kullmar M, Massoth C, Ostermann M, Campos S, Grau Novellas N, Thomson G, Haffner M, Arndt C, Wulf H, Irqsusi M, Monaco F, Di Prima A, Garcia Alvarez M, Italiano S, Cegarra SanMartin V, Kunst G, Nair S, L'Acqua C, Hoste EAJ, Vandenberghe W, Honore PM, Kellum J, Forni L, Grieshaber P, Weiss R, Gerss J, Wempe C, Meersch M, Zarbock A. Biomarker-guided implementation of the KDIGO guidelines to reduce the occurrence of acute kidney injury in patients after cardiac surgery (PrevAKI-multicentre): protocol for a multicentre, observational study followed by randomised controlled feasibility trial. BMJ Open. 2020 Apr 6;10(4):e034201. doi: 10.1136/bmjopen-2019-034201.
- Background: PubMed 31303781Vives M, Hernandez A, Parramon F, Estanyol N, Pardina B, Munoz A, Alvarez P, Hernandez C. Acute kidney injury after cardiac surgery: prevalence, impact and management challenges. Int J Nephrol Renovasc Dis. 2019 Jul 2;12:153-166. doi: 10.2147/IJNRD.S167477. eCollection 2019.
- Background: PubMed 35039910Van den Eynde J, Schuermans A, Verbakel JY, Gewillig M, Kutty S, Allegaert K, Mekahli D. Biomarkers of acute kidney injury after pediatric cardiac surgery: a meta-analysis of diagnostic test accuracy. Eur J Pediatr. 2022 May;181(5):1909-1921. doi: 10.1007/s00431-022-04380-4. Epub 2022 Jan 17.
- Background: PubMed 29858368Nadim MK, Forni LG, Bihorac A, Hobson C, Koyner JL, Shaw A, Arnaoutakis GJ, Ding X, Engelman DT, Gasparovic H, Gasparovic V, Herzog CA, Kashani K, Katz N, Liu KD, Mehta RL, Ostermann M, Pannu N, Pickkers P, Price S, Ricci Z, Rich JB, Sajja LR, Weaver FA, Zarbock A, Ronco C, Kellum JA. Cardiac and Vascular Surgery-Associated Acute Kidney Injury: The 20th International Consensus Conference of the ADQI (Acute Disease Quality Initiative) Group. J Am Heart Assoc. 2018 Jun 1;7(11):e008834. doi: 10.1161/JAHA.118.008834. No abstract available.
- Individual participant dataSharing planned: No
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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.
Reney A Henderson, MD principal investigator
University of Maryland, Baltimore
Questions about this trial
What is this clinical trial studying?
A study testing Goal Directed Fluid Therapy in people with Renal Injury and Acute Kidney Injury, run by University of Maryland, Baltimore.
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 2 inclusion and 5 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: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Reney A Henderson, MD (4103283961, rhenderson@som.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Kidney Injury (time frame: 7 days or discharge whichever occurs first). The study lists 2 primary outcomes in all. 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 NCT06109714, which also lists 4 linked publications.
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 5 Nov 2026.