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

Mayo Clinic

Status: Completed

Conditions: Acute Kidney Injury

Treatments: Other: Conventional management arm; Other: AKI sniffer instigated AKI management

Study type: Interventional

Funder types: Other

Identifiers

NCT01621152

11-000007

Details and patient eligibility

About

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.

Full 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).

Enrollment: 2,266 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,266 participants in 2 patient groups

Conventional management arm

Other group

Description:

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

Treatment:

Other: Conventional management arm

AKI sniffer instigated AKI management

Active Comparator group

Description:

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

Treatment:

Other: AKI sniffer instigated AKI management