PRevention of Acute Kidney Injury Initiated With Electronic Surveillance Enhancement

Acute Kidney Injury Clinical Trial

— PRAISE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01621152
• Other study ID #: 11-000007
• Status: Completed
• Phase: N/A
• Start date: June 2012
• Est. completion date: October 19, 2021

Study information

• Verified date: June 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2266
• Est. completion date: October 19, 2021
• Est. primary completion date: October 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Intervention

Other:
• Conventional management arm
Based on KDIGO guidelines and as per primary physician in the ICU
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Mayo Clinic Clinical Trials