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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
University of Campinas, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 24, 2022
    Last Updated
    November 3, 2022
    Sponsor
    University of Campinas, Brazil
    Collaborators
    Universidade Estadual Paulista Júlio de Mesquita Filho
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    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

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