Clinical trial NCT01621152: PRevention of Acute Kidney Injury Initiated With Electronic Surveillance Enhancement
Official title: Electronic Surveillance Sniffer for Early Detection and Intervention for Acute Kidney Injury: PRAISE Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Keywords: Acute renal failure
acute kidney injury
electronic surveillance
AKI
sniffer
AKIN
improvement in the process of care and outcomes
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-06-18
Enrollment: 2266
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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).

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)

Primary outcomes:
measure: Change in acute kidney injury as measured by the Acute Kidney Injury Network Staging System
timeFrame: baseline, 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Kianoush Kashani, MD
role: PRINCIPAL_INVESTIGATOR
References: