PRevention of Acute Kidney Injury Initiated With Electronic Surveillance Enhancement

NCT ID: NCT01621152

Last Updated: 2022-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2266 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2021-10-19

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).

Conditions

Acute Kidney Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Conventional management arm

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

Group Type: OTHER

Conventional management arm

Intervention Type: OTHER

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

AKI sniffer instigated AKI management

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

Group Type: ACTIVE_COMPARATOR

AKI sniffer instigated AKI management

Intervention Type: 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.

Interventions

Conventional management arm

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

Intervention Type: 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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Kianoush B. Kashani

Consultant in Nephrology and Critical Care Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kianoush Kashani, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

11-000007

Identifier Type: -

Identifier Source: org_study_id