Care Bundle and Acute Kidney Injury Progression

Not Applicable

Not yet recruiting

• Conditions: Acute Kidney Injury
• Interventions: Other: Care bundle for AKI

• Registration Number: NCT05597332
• Lead Sponsor: University of Campinas, Brazil

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-10-24
• Study First Submitted QC: 2022-10-24
• Study First Posted: 2022-10-28
• Status Verified: 2022-11
• Study Start: 2022-11
• Last Update Submitted: 2022-11-03
• Last Update Posted: 2022-11-08
• Primary Completion: 2023-03
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Intervention	Care bundle for AKI	Insertion of care bundle in the electronic medical record of patients who develop AKI.

Primary Outcome Measures

Name	Time	Method
AKI progression	≤ 7 days from inclusion	AKI progression from KDIGO 1 to KDIGO 2 or 3

Secondary Outcome Measures

Name	Time	Method
Adherence to care bundle	≤ 7 days from inclusion	Adhesion rate associated to AKI-care bundle