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KDIGO Bundle to Prevent AKI in Sepsis

H

Hospital General Universitario Elche

Status

Unknown

Conditions

Septic Acute Kidney Injury

Treatments

Procedure: Preventive recommendations for kidney disease: guidelines for improving overall outcomes (KDIGO) for AKI

Study type

Interventional

Funder types

Other

Identifiers

NCT04222361
PI 42/2018

Details and patient eligibility

About

Summary: Controlled, prospective, randomized and randomized clinical trial of two intervention groups (standard care vs. preventive recommendations the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines for AKI) of patients diagnosed with sepsis and abdominal post-surgical septic shock with positive results in the risk determination of acute renal injury by NephroCheck® Test that integrates the urinary biomarkers TIMP-2 and IGFBP-7.

Hypothesis: The implementation of a package of preventive measures proposed by the KDIGO guide can reduce the occurrence and severity of acute renal injury in the high-risk abdominal post-surgical septic patient detected by urinary biomarkers for early detection.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Patients older than 18 years.
  • Patients (or their informed family members) who accept and sign the informed consent.
  • Patients diagnosed with sepsis or abdominal post-surgical septic shock.

Exclusion criteria

  • Patients under 18 years.
  • Patients (or their authorized relatives) who refuse to sign the informed consent.
  • Patients diagnosed with sepsis or non-surgical septic shock.
  • Patients diagnosed with sepsis or septic shock of origin other than abdominal.
  • Patients with AKI stages KDIGO 2 and 3 and / or renal replacement therapy.
  • Patients with chronic renal failure and glomerular filtration <30 ml / min and / or undergoing treatment with dialysis or previous renal transplantation.
  • Patients with AKI of origin other than the diagnosed septic, such as glomerulonephritis or interstitial nephritis, renal artery occlusion and / or postrenal obstruction.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

100 participants in 2 patient groups

KDIGO guide recommendations
Experimental group
Description:
Preventive recommendations the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines for AKI
Treatment:
Procedure: Preventive recommendations for kidney disease: guidelines for improving overall outcomes (KDIGO) for AKI
Standard care
No Intervention group
Description:
The patients assigned to the control group will receive the current standard care of the septic patients of the Unit according to our protocols

Trial contacts and locations

1

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Central trial contact

Maria Mercader Alarcon, MD, DESA

Data sourced from clinicaltrials.gov

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