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Care Bundle and Acute Kidney Injury Progression

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05597332
Enrollment
400
Registered
2022-10-28
Start date
2022-11-30
Completion date
2023-07-31
Last updated
2022-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

Keywords

Acute kidney injury, Care bundle, Critical patients

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.

Interventions

OTHERCare bundle for AKI

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.

Sponsors

Universidade Estadual Paulista Júlio de Mesquita Filho
CollaboratorOTHER
University of Campinas, Brazil
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Before and after study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
AKI progression≤ 7 days from inclusionAKI progression from KDIGO 1 to KDIGO 2 or 3

Secondary

MeasureTime frameDescription
Adherence to care bundle≤ 7 days from inclusionAdhesion rate associated to AKI-care bundle

Contacts

Primary ContactLygia Lussim
lylussim@gmail.com+55 19 3521-7362

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026