search
Back to results

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

Primary Purpose

Acute Kidney Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Conventional management arm
AKI sniffer instigated AKI management
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Acute Kidney Injury focused on measuring Acute renal failure, acute kidney injury, electronic surveillance, AKI, sniffer, AKIN, improvement in the process of care and outcomes

Eligibility Criteria

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

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)

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Conventional management arm

AKI sniffer instigated AKI management

Arm Description

Patients with AKI receive standard of care in the conventional manner by the primary clinicians

primary clinicians for the AKI patients in this arm receive a verbal alert and reminder of KDIGO guidelines.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 14, 2012
Last Updated
June 21, 2022
Sponsor
Mayo Clinic
search

1. Study Identification

Unique Protocol Identification Number
NCT01621152
Brief Title
PRevention of Acute Kidney Injury Initiated With Electronic Surveillance Enhancement
Acronym
PRAISE
Official Title
Electronic Surveillance Sniffer for Early Detection and Intervention for Acute Kidney Injury: PRAISE Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
June 2012 (Actual)
Primary Completion Date
October 19, 2021 (Actual)
Study Completion Date
October 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

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
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
Acute renal failure, acute kidney injury, electronic surveillance, AKI, sniffer, AKIN, improvement in the process of care and outcomes

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2266 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional management arm
Arm Type
Other
Arm Description
Patients with AKI receive standard of care in the conventional manner by the primary clinicians
Arm Title
AKI sniffer instigated AKI management
Arm Type
Active Comparator
Arm Description
primary clinicians for the AKI patients in this arm receive a verbal alert and reminder of KDIGO guidelines.
Intervention Type
Other
Intervention Name(s)
Conventional management arm
Intervention Description
Based on KDIGO guidelines and as per primary physician in the ICU
Intervention Type
Other
Intervention Name(s)
AKI sniffer instigated AKI management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in acute kidney injury as measured by the Acute Kidney Injury Network Staging System
Description
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.
Time Frame
baseline, 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kianoush Kashani, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We plan to share IPD after initiation of patient recruitment.
Links:
URL
http://clinicaltrials.mayo.edu
Description
Mayo Clinic Clinical Trials

Learn more about this trial

PRevention of Acute Kidney Injury Initiated With Electronic Surveillance Enhancement

We'll reach out to this number within 24 hrs