PRevention of Acute Kidney Injury Initiated With Electronic Surveillance Enhancement

NCT01621152 | Completed

• 1 other identifier: 11-000007
• Study Type: interventional
• Target: 2,266
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Keywords

Acute renal failure; acute kidney injury; electronic surveillance; AKI; sniffer; AKIN; improvement in the process of care and outcomes

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Conventional management arm

OTHER

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

Other: Conventional management arm

AKI sniffer instigated AKI management

ACTIVE COMPARATOR

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

Other: AKI sniffer instigated AKI management

Interventions

Conventional management arm OTHER

Based on KDIGO guidelines and as per primary physician in the ICU

Conventional management arm

AKI sniffer instigated AKI management OTHER

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.

AKI sniffer instigated AKI management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Kianoush Kashani, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Nephrology and Critical Care Medicine

Study Record Dates

• First Submitted: May 14, 2012
• First Posted: June 18, 2012
• Study Start: June 1, 2012
• Primary Completion: October 19, 2021
• Study Completion: October 19, 2021
• Last Updated: June 22, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)