Care Bundle and Acute Kidney Injury Progression
Primary Purpose
Acute Kidney Injury
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Care bundle for AKI
Sponsored by
About this trial
This is an interventional prevention trial for Acute Kidney Injury focused on measuring Acute kidney injury, Care bundle, Critical patients
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Intervention
Arm Description
Insertion of care bundle in the electronic medical record of patients who develop AKI.
Outcomes
Primary Outcome Measures
AKI progression
AKI progression from KDIGO 1 to KDIGO 2 or 3
Secondary Outcome Measures
Adherence to care bundle
Adhesion rate associated to AKI-care bundle
Full Information
NCT ID
NCT05597332
First Posted
October 24, 2022
Last Updated
November 3, 2022
Sponsor
University of Campinas, Brazil
Collaborators
Universidade Estadual Paulista Júlio de Mesquita Filho
1. Study Identification
Unique Protocol Identification Number
NCT05597332
Brief Title
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
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2022 (Anticipated)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campinas, Brazil
Collaborators
Universidade Estadual Paulista Júlio de Mesquita Filho
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
Acute kidney injury, Care bundle, Critical patients
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Before and after study
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Other
Arm Description
Insertion of care bundle in the electronic medical record of patients who develop AKI.
Intervention Type
Other
Intervention Name(s)
Care bundle for AKI
Intervention Description
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.
Primary Outcome Measure Information:
Title
AKI progression
Description
AKI progression from KDIGO 1 to KDIGO 2 or 3
Time Frame
≤ 7 days from inclusion
Secondary Outcome Measure Information:
Title
Adherence to care bundle
Description
Adhesion rate associated to AKI-care bundle
Time Frame
≤ 7 days from inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lygia Lussim
Phone
+55 19 3521-7362
Email
lylussim@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lygia Lussim
Organizational Affiliation
University of Campinas, Brazil
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Care Bundle and Acute Kidney Injury Progression
We'll reach out to this number within 24 hrs