Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
NCT ID: NCT06109714
Last Updated: 2025-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2025-09-01
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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ACUMEN guided resuscitation protocol
Fluid resuscitation and hemodynamic management will be guided by ACUMEN based off a protocol.
Goal Directed Fluid Therapy
Fluid administration and hemodynamic management guided with the assistance of Edwards Lifesciences ACUMEN monitor
Standard of care resuscitation
Fluid resuscitation will be guided by standard monitors (urine output, blood loss, transesophageal echocardiography).
No interventions assigned to this group
Interventions
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Goal Directed Fluid Therapy
Fluid administration and hemodynamic management guided with the assistance of Edwards Lifesciences ACUMEN monitor
Eligibility Criteria
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Inclusion Criteria
* Procedure coronary artery bypass grafting, aortic valve replacement, or both
Exclusion Criteria
* Emergent surgery
* Preoperative kidney disease (Cr \> 2.0 or on renal replacement therapy)
* Ejection fraction \< 40%
* Incomplete data in medical record
18 Years
90 Years
ALL
Yes
Sponsors
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University of Maryland, Baltimore
OTHER
Responsible Party
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Reney Henderson
Assistant Professor
Principal Investigators
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Reney A Henderson, MD
Role: PRINCIPAL_INVESTIGATOR
University of Maryland, Baltimore
Central Contacts
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References
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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.
Vives 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.
Van 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.
Nadim 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.
Other Identifiers
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HP-00100950
Identifier Type: -
Identifier Source: org_study_id
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