Care Bundle and Acute Kidney Injury Progression

NCT05597332 | Unknown

• 1 other identifier: 61447422.1.1001.5404
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Kidney Injury

Keywords

Acute kidney injury; Care bundle; Critical patients

Outcome Measures

Primary Outcomes (1)

• AKI progression

  AKI progression from KDIGO 1 to KDIGO 2 or 3

  ≤ 7 days from inclusion

Secondary Outcomes (1)

• Adherence to care bundle

  ≤ 7 days from inclusion

Study Arms (1)

Intervention

OTHER

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

Other: Care bundle for AKI

Interventions

Care bundle for AKI 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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with recent ICU admission (≤ 48 hours)
• Patients without AKI or with AKI KDIGO 1 at the time of admission

You may not qualify if:

• Patients with chronic kidney disease, stage 4 to 5D
• Patients with kidney transplant

Sponsors & Collaborators

• University of Campinas, Brazil: lead
• Universidade Estadual Paulista Júlio de Mesquita Filho: collaborator

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Patient Care Bundles

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Lygia Lussim

  University of Campinas, Brazil

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lygia Lussim

CONTACT

+55 19 3521-7362; lylussim@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Before and after study

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: October 28, 2022
• Study Start: November 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: July 1, 2023
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share