KDIGO Bundle to Prevent AKI in Sepsis

Prevention of Acute Renal Injury in the Septic Patient by Implementing the KDIGO Guideline in High-risk Patients Identified by Biomarkers

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.

Study Overview

• Status: Unknown
• Conditions: Septic Acute Kidney Injury
• Intervention / Treatment: Procedure: Preventive recommendations for kidney disease: guidelines for improving overall outcomes (KDIGO) for AKI

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alicante
    • Elche, Alicante, Spain, 03203
      • Recruiting
      • Surgical Intensive Care Unit of the General University Hospital of Elche
      • Contact: Ana Perez Carbonell, MD, PhD; Phone Number: +34605266485; Email: perez_anacar@gva.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KDIGO guide recommendations; Preventive recommendations the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines for AKI	Procedure: Preventive recommendations for kidney disease: guidelines for improving overall outcomes (KDIGO) for AKI; Patients assigned to the treatment group will receive the AKI preventive recommendations from the KDIGO guide: withdraw nephrotoxics, ensure volemia and renal perfusion pressure by means of advanced hemodynamic monitoring-optimization (minimum monitoring objective: Unit algorithm based on volume systolic (VS) by pulse wave analysis - Flotrac® / ClearSight® system - or transpulmonary thermodilution - VolumeView® system -), monitor plasma creatinine and urinary expenditure, avoid hyperglycemia (serum blood glucose target: 110-149 mg / dl), and consider alternatives to diagnostic-therapeutic radiocontrast procedures.
No Intervention: Standard care; The patients assigned to the control group will receive the current standard care of the septic patients of the Unit according to our protocols

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the incidence of moderate-severe acute renal injury	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	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare mortality from any cause	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	90 days
Compare the number of participants in need of renal replacement therapy	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	90 days
Compare the number of participants with persistent renal dysfunction	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	90 days
Compare the number of days of stay in the Surgical ICU	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	90 days
Compare the number of days of stay in the hospital	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	90 days
Measure the incidence of development of AKI in patients at low risk of AKI determined by NephroCheck® Test	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).	72 hours

Collaborators and Investigators

• Sponsor: Hospital General Universitario Elche

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: January 4, 2020
• First Submitted That Met QC Criteria: January 7, 2020
• First Posted (Actual): January 10, 2020

Study Record Updates

• Last Update Posted (Actual): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: PI 42/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No