Care Bundle and Acute Kidney Injury Progression

Study Overview
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Brief Summary
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The goal of this clinical interventional study is to learn about the effect of implementing a care bundle in the progression of acute kidney injury (AKI) in critical patients. The main questions it aims to answer are: What is the impact of care bundle in AKI progression? Some improvement of care bundle adhesion rate through an electronic alert can be achieved? Participants will be adults and critical patients with AKI. During observational study the incidence and progression of AKI will be measured, as well spontaneous care bundle adhesion by medical team. In the interventional study, the progression rate of AKI influenced by care bundle will be measured, as well the adhesion of care bundle through an electronic alert inserted in the patient's daily medical record.

Detailed Description
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This is a clinical, multicentric and prospective trial (study type: before and after). Patients aged ≥18 years, admitted to clinical and surgical intensive care units (ICUs) will be included according to selection criteria. During observational and interventional studies clinical and laboratorial information from electronic medical records will be registered. AKI diagnosis and classification will be based on serum creatinine levels according to kidney disease improving global outcomes (KDIGO) criteria. The observational study will be carried out to measure the incidence of AKI KDIGO 1 and its progression rate, in order to estimate sample size for the interventional study. Researchers assumed a 10% to 20% reduction in the progression of AKI KDIGO 1 to more advanced stages after the implementation of the care bundle. In the interventional study, the care bundle will be included in the medical records of each individual who develops AKI KDIGO 1. Patients included in this study will be followed by 7 days from inclusion. Adhesion rate to the care bundle will be measured between observational and interventional studies.

Official Title
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Effect of Implementing a Care Bundle on the Progression of Acute Kidney Injury in Critical Patients

Conditions
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Acute Kidney Injury

Intervention / Treatment
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* Other: Care bundle for AKI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with recent ICU admission (≤ 48 hours) Patients without AKI or with AKI KDIGO 1 at the time of admission Exclusion Criteria: Patients with chronic kidney disease, stage 4 to 5D Patients with kidney transplant Patients with AKI KDIGO 2, 3 or on dialysis at the time of inclusion in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Sequential Assignment
Interventional Model Description: Before and after study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention<br>Insertion of care bundle in the electronic medical record of patients who develop AKI. | Other: Care bundle for AKI<br>* To maintain mean arterial pressure (MAP) ≥ 65 mmHg; to keep the patient euvolemic; to avoid nephrotoxic drugs; to adjust dose of medication for kidney function; to exclude urinary obstruction; to monitor urine output and serum creatinine levels.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AKI progression | AKI progression from KDIGO 1 to KDIGO 2 or 3 | ≤ 7 days from inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to care bundle | Adhesion rate associated to AKI-care bundle | ≤ 7 days from inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute kidney injury, Care bundle, Critical patients