PRevention of Acute Kidney Injury Initiated With Electronic Surveillance Enhancement (PRAISE)

Electronic Surveillance Sniffer for Early Detection and Intervention for Acute Kidney Injury: PRAISE Trial

Introduction: Acute kidney injury (AKI) increases mortality, hospital cost, and rate of progression toward end stage kidney disease 1-4. Early diagnosis and management of AKI is known to improve the above mentioned outcomes.

Hypothesis: the investigators will design and validate an electronic surveillance tool to screen all the ICU admissions for the earlier, more efficient diagnosis of AKI and as a result improve the outcome of AKI in ICU patients.

Methods: the investigators plan to use the patient database, and AKIN (AKI network) definition to design an electronic alert system to allow clinicians discover patients who develop AKI. Then a randomized clinical trial will be conducted to compare earlier intervention (based on Kidney Disease: Improving Global Outcomes [KDIGO] guidelines) initiated by AKI sniffer alert to the conventional management provided by primary physician in ICU.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Other: Conventional management arm; Other: AKI sniffer instigated AKI management

Detailed Description

A prospective controlled, unblinded clinical trial will be conducted among AKI patients who are detected by the use of AKI sniffer. The investigators will randomize consecutive patients who were detected to have AKI by AKI sniffer into two groups. In one group (control group), patients will receive standard clinical care by the primary ICU physicians. The primary physicians who take care of the control subjects will be kept blinded of the results of the AKI sniffer. All the ICU physicians will receive a copy of KDIGO (March 2012) guidelines for management of AKI prior to the initiation of the patient accrual. In the intervention group, the research team will inform the primary care team about the occurrence of the AKI and provides a copy of KDIGO guidelines for management of AKI to the clinicians. Each subject will be followed until hospital discharge or for a maximum of 3 months, for clinical and laboratory data including peak serum creatinine, creatinine at the end of follow up, peak AKIN stage, along with other secondary outcomes. The investigators will exclude the prevalent cases (AKI patients who have had AKI documented in their medical records by clinicians prior to the ICU admission).

• Study Type: Interventional
• Enrollment (Actual): 2266
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All patients who are admitted in adult ICUs in Mayo Clinic Rochester
• Foley catheter for hourly UOP measurement

Exclusion Criteria:

• Prisoners
• Patients less than 18 years old.
• Lack of research authorization (in control group)
• ESRD on dialysis or s/p kidney transplantation
• Known AKI before admission to ICU
• Moribund patients
• Prevalent AKI admission in ICU (patients who have diagnosis of AKI documented in their medical records prior to ICU admission)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Conventional management arm; Patients with AKI receive standard of care in the conventional manner by the primary clinicians	Other: Conventional management arm; Based on KDIGO guidelines and as per primary physician in the ICU
Active Comparator: AKI sniffer instigated AKI management; primary clinicians for the AKI patients in this arm receive a verbal alert and reminder of KDIGO guidelines.	Other: AKI sniffer instigated AKI management; After identification of patients with AKI by the sniffer, primary physicians will be notified about the development of the syndrome and will be given a copy of the KDIGO guidelines for management of AKI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in acute kidney injury as measured by the Acute Kidney Injury Network Staging System	The Acute Kidney Injury Network staging system is based on data indicating that a small change in serum creatinine influences outcome. Increases in serum creatinine or decreased urine output indicate greater kidney injury, with the stage ranging from 1 to 3. The higher the number, the greater the kidney injury.	baseline, 4 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Kianoush Kashani, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2012
• Primary Completion (Actual): October 19, 2021
• Study Completion (Actual): October 19, 2021

Study Registration Dates

• First Submitted: May 14, 2012
• First Submitted That Met QC Criteria: June 15, 2012
• First Posted (Estimate): June 18, 2012

Study Record Updates

• Last Update Posted (Actual): June 22, 2022
• Last Update Submitted That Met QC Criteria: June 21, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Acute renal failure; acute kidney injury; AKI; electronic surveillance; sniffer; AKIN; improvement in the process of care and outcomes
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: 11-000007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: We plan to share IPD after initiation of patient recruitment.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No