Care Bundle and Acute Kidney Injury Progression | NCT05597332

Studies
Care Bundle and Acute Kidney Injury Progression

NCT05597332

Sponsor

University of Campinas, Brazil

Status

Unknown status

Last Update Posted

Nov 8, 2022Actual

Enrollment

400Estimated

Phase

Not Applicable

Conditions

Acute Kidney Injury

Interventions

Care bundle for AKI

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2022Estimated

Primary Completion Date

Mar 2023Estimated

Completion Date

Jul 2023Estimated

First Submitted Date

Oct 24, 2022

First Submission Date that Met QC Criteria

Oct 24, 2022

First Posted Date

Oct 28, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 3, 2022

Last Update Posted Date

Nov 8, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lygia Lussim, Principal Investigator, University of Campinas, BrazilPrincipal Investigator

Lead Sponsor

University of Campinas, BrazilOTHER

Collaborators

Name	Class
Universidade Estadual Paulista Júlio de Mesquita Filho	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Other	Insertion of care bundle in the electronic medical record of patients who develop AKI.	Other: Care bundle for AKI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AKI progression	AKI progression from KDIGO 1 to KDIGO 2 or 3	≤ 7 days from inclusion

Secondary Outcomes

Measure	Description	Time Frame
Adherence to care bundle	Adhesion rate associated to AKI-care bundle	≤ 7 days from inclusion

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lygia Lussim	Contact	+55 19 3521-7362		lylussim@gmail.com

Overall Officials

Name	Affiliation	Role
Lygia Lussim	University of Campinas, Brazil	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D064872	Patient Care Bundles

Ancestor Terms

ID	Term
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided