KDIGO Bundle to Prevent AKI in Sepsis

Not Applicable

• Conditions: Septic Acute Kidney Injury

• Registration Number: NCT04222361
• Lead Sponsor: Hospital General Universitario Elche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-04
• Study First Submitted QC: 2020-01-07
• Study First Posted: 2020-01-10
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-27
• Last Update Posted: 2020-07-28
• Study Start: 2020-10
• Primary Completion: 2022-06
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Compare the incidence of moderate-severe acute renal injury	72 hours	Compare the incidence of moderate-severe acute renal injury (stages KDIGO 2 and 3) in the first 72 hours of diagnosis of sepsis and septic post-surgical septic shock in patients at high risk of AKI determined by NephroCheck® Test (those with a ≥0.3 ng / ml2 / 1000 result) that the package of preventive measures proposed by the KDIGO guideline is applied vs. standard treatment

Secondary Outcome Measures

Name	Time	Method
Compare the number of participants in need of renal replacement therapy	90 days	Compare the number of participants in need of renal replacement therapy at 12, 24, 48 and 72 hours, and 30, 60 and 90 days in patients diagnosed with sepsis and abdominal post-surgical septic shock and high risk of AKI determined by NephroCheck® Test (those with result ≥0.3 ng / ml2 / 1000) that the package of preventive measures proposed by the KDIGO guideline is applied vs. standard treatment
Compare the number of days of stay in the Surgical ICU	90 days	Compare the number of days of stay in the Surgical ICU in patients diagnosed with sepsis and septic post-surgical septic shock and high risk of AKI determined by NephroCheck® Test (those with a result ≥0.3 ng / ml2 / 1000) that apply the package of preventive measures proposed by the guide KDIGO vs. standard treatment
Compare mortality from any cause	90 days	Compare mortality from any cause at 12, 24, 48 and 72 hours, and 30, 60 and 90 days in patients diagnosed with sepsis and abdominal post-surgical septic shock and high risk of AKI determined by NephroCheck® Test (patients with results ≥0.3 ng / ml2 / 1000) that the package of preventive measures proposed by the KDIGO guideline is applied vs. standard treatment
Compare the number of participants with persistent renal dysfunction	90 days	Compare the number of participants with persistent renal dysfunction at 30, 60 and 90 days in patients diagnosed with sepsis and abdominal post-surgical septic shock and high risk of AKI determined by NephroCheck® Test (those with a ≥0.3 ng / ml2 / 1000 result) that the package of preventive measures proposed by the KDIGO guideline is applied vs. standard treatment
Compare the number of days of stay in the hospital	90 days	Compare the number of days of stay in the hospital in patients diagnosed with sepsis and abdominal post-surgical septic shock and high risk of AKI determined by NephroCheck® Test (those with a result ≥0.3 ng / ml2 / 1000) that apply the package of preventive measures proposed by the KDIGO guide vs. standard treatment
Measure the incidence of development of AKI in patients at low risk of AKI determined by NephroCheck® Test	72 hours	Measure the incidence of development of AKI (any KDIGO stage) at 12, 24, 48 and 72 hours after diagnosis of sepsis and septic post-surgical septic shock in patients at low risk of AKI determined by NephroCheck® Test (those with a result of 0.3 ng / ml2 / 1000).

Trial Locations

Locations (1)

Surgical Intensive Care Unit of the General University Hospital of Elche; 🇪🇸 Elche, Alicante, Spain