Back to resultsKDIGO Bundle to Prevent AKI in Sepsis
Primary Purpose
Septic Acute Kidney Injury
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Preventive recommendations for kidney disease: guidelines for improving overall outcomes (KDIGO) for AKI
Sponsored by
About this trial
This is an interventional prevention trial for Septic Acute Kidney Injury
Eligibility Criteria
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.
Sites / Locations
- Surgical Intensive Care Unit of the General University Hospital of ElcheRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
KDIGO guide recommendations
Standard care
Arm Description
Preventive recommendations the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines for AKI
The patients assigned to the control group will receive the current standard care of the septic patients of the Unit according to our protocols
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
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
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).
Full Information
NCT ID
NCT04222361
First Posted
January 4, 2020
Last Updated
July 27, 2020
Sponsor
Hospital General Universitario Elche
1. Study Identification
Unique Protocol Identification Number
NCT04222361
Brief Title
KDIGO Bundle to Prevent AKI in Sepsis
Official Title
Prevention of Acute Renal Injury in the Septic Patient by Implementing the KDIGO Guideline in High-risk Patients Identified by Biomarkers
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 2020 (Anticipated)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General Universitario Elche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Acute Kidney Injury
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
KDIGO guide recommendations
Arm Type
Experimental
Arm Description
Preventive recommendations the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines for AKI
Arm Title
Standard care
Arm Type
No Intervention
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Preventive recommendations for kidney disease: guidelines for improving overall outcomes (KDIGO) for AKI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Compare the incidence of moderate-severe acute renal injury
Description
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
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Compare mortality from any cause
Description
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
Time Frame
90 days
Title
Compare the number of participants in need of renal replacement therapy
Description
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
Time Frame
90 days
Title
Compare the number of participants with persistent renal dysfunction
Description
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
Time Frame
90 days
Title
Compare the number of days of stay in the Surgical ICU
Description
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
Time Frame
90 days
Title
Compare the number of days of stay in the hospital
Description
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
Time Frame
90 days
Title
Measure the incidence of development of AKI in patients at low risk of AKI determined by NephroCheck® Test
Description
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).
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Mercader Alarcon, MD, DESA
Phone
+34696195678
Email
mariamercader@hotmail.com
Facility Information:
Facility Name
Surgical Intensive Care Unit of the General University Hospital of Elche
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Perez Carbonell, MD, PhD
Phone
+34605266485
Email
perez_anacar@gva.es
12. IPD Sharing Statement
Plan to Share IPD
No
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KDIGO Bundle to Prevent AKI in Sepsis
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