Clinical trial NCT06109714: Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Official title: Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Renal Injury
Acute Kidney Injury
Keywords: Cardiac Surgery
Cardiac Surgery Induced Kidney Injury
Kidney Biomarkers
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Adult patients undergoing cardiopulmonary bypass
* Procedure coronary artery bypass grafting, aortic valve replacement, or both

Exclusion Criteria:

* 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

Primary outcomes:
measure: Acute Kidney Injury
timeFrame: 7 days or discharge whichever occurs first
measure: Renal Biomarkers
timeFrame: 48 hours postoperatively
Secondary outcomes:
measure: Total Fluid Administered
timeFrame: From initiation of surgery to 48 hours postoperatively
measure: ICU Length of Stay
timeFrame: From admission to the intensive care unit until discharge or 20 weeks whichever comes first.
measure: Hemodynamic Support Usage
timeFrame: During the first 48 hours postoperatively
measure: Morbidity and Mortality
timeFrame: 30 days
measure: Blood Transfusions
timeFrame: From surgical incision to 48 hours postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: University of Maryland, Baltimore
name: Reney A Henderson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.