Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery

Acute Kidney Injury Clinical Trial

— BE-KIND  

Official title:

Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06109714
• Other study ID #: HP-00100950
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: December 31, 2028

Study information

• Verified date: April 2024
• Source: University of Maryland, Baltimore
• Contact: Reney A Henderson, MD
• Phone: 4103283961
• Email: rhenderson[@]som.umaryland.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2028
• Est. primary completion date: April 1, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Renal Injury
• Wounds and Injuries

Intervention

Other:
• Goal Directed Fluid Therapy
Fluid administration and hemodynamic management guided with the assistance of Edwards Lifesciences ACUMEN monitor

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Kidney Injury	KIDIGO Criteria for AKI	7 days or discharge whichever occurs first
Primary	Renal Biomarkers	NGAL, Hepcidin-25, and Uromodulin	48 hours postoperatively
Secondary	Total Fluid Administered	intraoperative and postoperative volume given measured in milliliters	From initiation of surgery to 48 hours postoperatively
Secondary	ICU Length of Stay	Quantified in days and hours	From admission to the intensive care unit until discharge or 20 weeks whichever comes first.
Secondary	Hemodynamic Support Usage	Vasopressor or Inotrope usage	During the first 48 hours postoperatively
Secondary	Morbidity and Mortality	Death and Major adverse events (cerebral vascular stroke, myocardial infarction, infection, prolonged intubation > 24 hours)	30 days
Secondary	Blood Transfusions	Any Allogeneic Blood Transfusions	From surgical incision to 48 hours postoperatively