Skip to main content
OpenTrials
Completed

NCT Number: NCT01621152

PRevention of Acute Kidney Injury Initiated With Electronic Surveillance Enhancement

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Conventional management arm

Other

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

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.

Primary outcomes

  1. Change in acute kidney injury as measured by the Acute Kidney Injury Network Staging System

    Time frame: baseline, 4 weeks

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Acronym: PRAISE

Important dates

Study start
2012
Primary completion
2021
Study completion
2021
First posted
Jun 18, 2012
Registry last updated
Jun 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.