Care Bundle and Acute Kidney Injury Progression

NCT ID: NCT05597332

Last Updated: 2022-11-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-30
• Study Completion Date: 2023-07-31

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.

Conditions

Acute Kidney Injury

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention

Insertion of care bundle in the electronic medical record of patients who develop AKI.

Group Type: OTHER

Care bundle for AKI

Intervention Type: OTHER

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.

Interventions

Care 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Estadual Paulista Júlio de Mesquita Filho

OTHER

Sponsor Role: collaborator

University of Campinas, Brazil

OTHER

Sponsor Role: lead

Responsible Party

Lygia Lussim

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lygia Lussim

Role: PRINCIPAL_INVESTIGATOR

University of Campinas, Brazil

Central Contacts

Lygia Lussim

Role: CONTACT

lylussim@gmail.com

+55 19 3521-7362

Other Identifiers

61447422.1.1001.5404

Identifier Type: -

Identifier Source: org_study_id