RBR-3b7rqpv Early detection of acute kidney injury in patients undergoing cardiac surgery

Date of registration: 07/01/2026 ^(mm/dd/yyyy)
Last approval date : 07/01/2026 ^(mm/dd/yyyy)

Study type:

Observational

Scientific title:

Trial identification

• UTN code: U1111-1339-6104

• Public title:

  en

  Early detection of acute kidney injury in patients undergoing cardiac surgery

  pt-br

  Detecção precoce de lesão renal aguda em pacientes submetidos à cirurgia cardíaca

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 62492022.6.0000.0048
    Issuing authority: Plataforma Brasil
  • 6.767.765
    Issuing authority: Comitê de Ética em Pesquisa do Hospital São Rafael

Sponsors

• Primary sponsor: Hospital São Rafael
• Secondary sponsor:
  • Institution: Hospital Aliança
• Supporting source:
  • Institution: Hospital São Rafael

Health conditions

• Health conditions:

  en

  Acute Kidney Injury

  pt-br

  Injúria Renal Aguda

• General descriptors for health conditions:

  en

  H02.403.810.803 Thoracic Surgery

  pt-br

  H02.403.810.803 Cirurgia Cardíaca

• Specific descriptors:

  en

  C12.050.351.968.419.780.050 Acute Kidney Injury

  pt-br

  C12.050.351.968.419.780.050 Injúria Renal Aguda

Interventions

• Interventions:

  en

  This is a prospective observational study, without a control group and without intervention. Patients undergoing cardiac surgery, after signing an informed consent form, had baseline (pre-procedure) blood and urine samples collected, and again 4 hours after surgery. Renal tubular phosphorus transport was evaluated through calculations of excreted load, maximum phosphorus transport, and maximum phosphorus transport normalized by glomerular filtration. In addition, serum levels of the biomarker fibroblast growth factor 23 (FGF-23) and urinary levels of the biomarker neutrophil gelatinase-associated lipocalin (NGAL) were also measured as early markers of acute kidney injury.

  pt-br

  Trata-se de um estudo observacional prospectivo, sem grupo controle e sem intervenção. Pacientes submetidos a cirurgias cardíacas, após termo de consentimento assinado, tiveram coleta de sangue e urina basal (pré procedimento) e 04 (quatro) horas após a cirurgias. Foram avaliados, desta forma, o transporte tubular renal de fósforo através de cálculos de carga excretada, transporte máximo de fósforo e trasnporte máximo de fósforo normatizado pela filtração glomerular. Além disso houve dosagens sérica do biomarcador fator de crescimento de fibroblastos 23 (FGF-23) e urinária do biomarcador lipocalina associada à gelatinase de neutrófilos (NGAL) também como marcadores precoces de lesão renal aguda.

• Descriptors:

  en

  D12.776.124.050.475 Lipocalin-2

  pt-br

  D12.776.124.050.475 Lipocalina Associada a Gelatinase de Neutrófilo

Recruitment

• Study status: Recruitment completed
• Countries
  • Brazil
• Date first enrollment: 10/11/2022 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  70	-	18 Y	80 Y

• Inclusion criteria:

  en

  Age over 18 years; Patients undergoing complex cardiac surgical procedures (cardiac surgeries using extracorporeal circulation or complex percutaneous valve repair) and vascular procedures (complex peripheral vascular revascularization surgeries); Possibility of accurate measurement of urine output for at least 24 hours after the procedure; Consent to participate in the study or a legally authorized representative who can legally consent

  pt-br

  Idade acima de 18 anos; Pacientes submetidos a procedimentos cirúrgicos cardíacos complexos (cirurgias cardíaca com utilização de circulação extracorpórea ou percutâneo complexo valvar) e vasculares (cirurgias de revascularização vascular periférica complexas); Possibilidade de correta mensuração de diurese por pelo menos por 24h após o procedimento; Consentir em participar do estudo ou representante legal que possa, legalmente, consentir

• Exclusion criteria:

  en

  Patients with estimated creatinine clearance < 30 ml/min; History of kidney transplant; Obstructive uropathy; Acute kidney injury (any grade) at the time of randomization; History of parathyroidectomy; History of hyperparathyroidism or hypoparathyroidism; History of active neoplasia; Anuria

  pt-br

  Pacientes com Clearance de creatinina estimado < 30ml/min; História de transplante renal; Uropatia obstrutiva; Lesão renal aguda (em qualquer grau) no momento da randomização; História de Paratireoidectomia; História de Hiperparatireoidismo ou Hipoparatireoidismo; História de neoplasia ativa; Anúria

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase

Outcomes

• Primary outcomes:

  en

  This study is expected to identify increased renal tubular transport of phosphorus, defined as a fractional excretion of phosphorus greater than 15% after 4 hours of the procedure, more strongly associated with patients who developed acute kidney injury during hospitalization according to KDIGO (Kidney Disease: Improving Global Outcomes) criteria

  pt-br

  Espera-se no presente estudo a identificação de transporte tubular renal de fósforo aumentado, definido como fração de excreção de fósforo maior que 15% após 4h do procedimento, em maior associação com pacientes que desenvolveram lesão renal aguda na internação de acordo com critérios do KDIGO (Kidney Disease: Improving Global Outcomes)

• Secondary outcomes:

  en

  Length of hospital stay, in-hospital death, need for hemodialysis, and changes in the biomarkers serum Fibroblast Growth Factor 23 (FGF-23) and urinary Neutrophil Gelatinase-Associated Lipocalin (NGAL) 4 hours after surgery will be evaluated

  pt-br

  Serão avaliados o tempo de hospitalização, óbito na internação, necessidade de hemodiálise, alteração em biomarcadores Fator de Crescimento de Fibroblastos 23 (FGF-23) sérico e Lipocalina associada à gelatinase neutrofílica (NGAL) urinário após 4 horas da cirurgia

Contacts

• Public contact
  • Full name: Marcelo Augusto Duarte Silveira
  • • Address: rua do benjoim, 71, apto 502
    • City: Salvador / Brazil
    • Zip code: 41820-340
  • Phone: +55(71)99970-6175
  • Email: marceloadsilveira@gmail.com
  • Affiliation: Hospital São Rafael
   
• Scientific contact
  • Full name: Marcelo Augusto Duarte Silveira
  • • Address: rua do benjoim, 71, apto 502
    • City: Salvador / Brazil
    • Zip code: 41820-340
  • Phone: +55(71)99970-6175
  • Email: marceloadsilveira@gmail.com
  • Affiliation: Hospital São Rafael
   
• Site contact
  • Full name: Marcelo Augusto Duarte Silveira
  • • Address: rua do benjoim, 71, apto 502
    • City: Salvador / Brazil
    • Zip code: 41820-340
  • Phone: +55(71)99970-6175
  • Email: marceloadsilveira@gmail.com
  • Affiliation: Hospital São Rafael
   

Additional links:

• Download in ICTRP format