Clinical trial NCT05597332: Care Bundle and Acute Kidney Injury Progression
Official title: Effect of Implementing a Care Bundle on the Progression of Acute Kidney Injury in Critical Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Kidney Injury
Keywords: Acute kidney injury
Care bundle
Critical patients
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
Collaborators: name: Universidade Estadual Paulista Júlio de Mesquita Filho
First posted: 2022-10-28
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Before and after study
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: AKI progression
timeFrame: ≤ 7 days from inclusion
Secondary outcomes:
measure: Adherence to care bundle
timeFrame: ≤ 7 days from inclusion
Other outcomes:
Locations:
Study officials:
affiliation: University of Campinas, Brazil
name: Lygia Lussim
role: PRINCIPAL_INVESTIGATOR
References: