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Personalized Kidney Care for Acute Kidney Injury

N/A

Recruiting

Led By Francis P Wilson

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults ≥ 18 years admitted to a participating hospital (six hospitals in the Yale New Haven Health system and two hospitals of the John Hopkins University Health system)

Stage 1 Acute Kidney Injury as defined by KDIGO creatinine criteria: 0.3 mg/dl increase in inpatient serum creatine over 48 hours OR 50% relative increase in inpatient serum creatinine over 168 hours

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours after randomization

Awards & highlights

Study Summary

This trial will test whether a "Kidney Action Team" can provide better care for hospitalized patients with Acute Kidney Injury.

Who is the study for?

This trial is for adults over 18 who are hospitalized with Stage 1 Acute Kidney Injury, as defined by specific increases in serum creatinine levels. It's not for those needing immediate dialysis, organ transplant recipients, hospice patients, those already under a nephrologist's care, or with advanced chronic kidney disease.Check my eligibility

What is being tested?

The study tests the effectiveness of 'Kidney Action Team' recommendations on diagnosis and initial treatment for hospitalized patients with Acute Kidney Injury. Participants will be randomly assigned to receive these personalized recommendations or not.See study design

What are the potential side effects?

Since this trial involves professional medical recommendations rather than drugs or invasive procedures, direct side effects are not anticipated. However, there may be indirect effects based on the treatments advised.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 or older and admitted to a hospital in the Yale or John Hopkins systems.

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My kidney function has recently worsened.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours after randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours after randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours after randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Composite outcome showing the percentage of participants with any one of the following: progression of AKI, inpatient dialysis, or inpatient death

Secondary outcome measures

Percentage of inpatient mortality

Percentage of patients who receive inpatient dialysis

Percentage of patients with progression of Acute Kidney Injury

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Kidney Action Team RecommendationsExperimental Treatment1 Intervention

Recommendations made by the Kidney Action Team will be delivered to the patient's primary care team within 30 minutes of AKI development.

Group II: Usual CareActive Control1 Intervention

Kidney Action Team Recommendations will not be delivered to the primary care teams of randomized patients.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,848 Previous Clinical Trials

2,733,818 Total Patients Enrolled

9 Trials studying Acute Kidney Injury

20,850 Patients Enrolled for Acute Kidney Injury

Johns Hopkins UniversityOTHER

2,260 Previous Clinical Trials

14,816,780 Total Patients Enrolled

5 Trials studying Acute Kidney Injury

5,813 Patients Enrolled for Acute Kidney Injury

Francis P WilsonPrincipal InvestigatorYale Univerisity

Media Library

Kidney Action Team Recommendations Clinical Trial Eligibility Overview. Trial Name: NCT04040296 — N/A

Acute Kidney Injury Research Study Groups: Usual Care, Kidney Action Team Recommendations

Acute Kidney Injury Clinical Trial 2023: Kidney Action Team Recommendations Highlights & Side Effects. Trial Name: NCT04040296 — N/A

Kidney Action Team Recommendations 2023 Treatment Timeline for Medical Study. Trial Name: NCT04040296 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have been enlisted in this clinical experiment?

"Affirmative. It is confirmed by the clinicaltrials.gov records that this trial has been open for enrollment since November 1st 2021, and was amended on February 3rd 2022. The project requires 4000 patients to be recruited from one site."

Answered by AI

Is the enrollment process still open for this research protocol?

"This medical trial, which was first advertised on November 1st 2021, is still actively seeking participants. According to the listing on clinicaltrials.gov its most recent edit occurred on February 3rd 2022."

Answered by AI

Recent research and studies

The LancetJournal

Automated, Electronic Alerts for Acute Kidney Injury: A Single-blind, Parallel-group, Randomised Controlled Trial

Wilson, F Perry, Michael Shashaty, Jeffrey Testani, Iram Aqeel, Yuliya Borovskiy, Susan S Ellenberg, Harold I Feldman, et al.. 2015. “Automated, Electronic Alerts for Acute Kidney Injury: A Single-blind, Parallel-group, Randomised Controlled Trial”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(15)60266-5.

clinicaltrials.govStudy

Personalized Recommendations for Acute Kidney Injury (AKI) Care

2021. "Personalized Recommendations for Acute Kidney Injury (AKI) Care". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04040296.