Care Bundle and Acute Kidney Injury Progression

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05597332
• Other study ID #: 61447422.1.1001.5404
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2022
• Est. completion date: July 2023

Study information

• Verified date: November 2022
• Source: University of Campinas, Brazil
• Contact: Lygia Lussim
• Phone: +55 19 3521-7362
• Email: lylussim[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: July 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Campinas, Brazil	Universidade Estadual Paulista Júlio de Mesquita Filho

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AKI progression	AKI progression from KDIGO 1 to KDIGO 2 or 3	= 7 days from inclusion
Secondary	Adherence to care bundle	Adhesion rate associated to AKI-care bundle	= 7 days from inclusion