We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01621152
First Posted: June 18, 2012
Last Update Posted: March 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kianoush B. Kashani, Mayo Clinic
  Purpose

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.


Condition Intervention
Acute Kidney Injury Other: Conventional management arm Other: AKI sniffer instigated AKI management

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Electronic Surveillance Sniffer for Early Detection and Intervention for Acute Kidney Injury: PRAISE Trial

Further study details as provided by Kianoush B. Kashani, Mayo Clinic:

Primary Outcome Measures:
  • Change in acute kidney injury as measured by the Acute Kidney Injury Network Staging System [ Time Frame: baseline, 4 weeks ]
    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.


Estimated Enrollment: 984
Study Start Date: June 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01621152


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Kianoush Kashani, MD Mayo Clinic
  More Information

Additional Information:
Responsible Party: Kianoush B. Kashani, Consultant in Nephrology and Critical Care Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01621152     History of Changes
Other Study ID Numbers: 11-000007
First Submitted: May 14, 2012
First Posted: June 18, 2012
Last Update Posted: March 22, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We plan to share IPD after initiation of patient recruitment.

Keywords provided by Kianoush B. Kashani, Mayo Clinic:
Acute renal failure
acute kidney injury
electronic surveillance
AKI
sniffer
AKIN
improvement in the process of care and outcomes

Additional relevant MeSH terms:
Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases