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Not yet recruiting NCT06109714

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

No phase Interventional Renal Injury Acute Kidney Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Goal Directed Fluid Therapy.
Who it may be relevant to
Registry conditions: Renal Injury, Acute Kidney Injury. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Acute Kidney Injury [Time frame: 7 days or discharge whichever occurs first]
  • Renal Biomarkers [Time frame: 48 hours postoperatively]
Secondary outcome measures (5)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

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 t PMID 32265240
  • 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. PMID 31303781
  • 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. PMID 35039910
  • 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 AD PMID 29858368

Identifiers

NCT: NCT06109714 · HP-00100950

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗