An interventional study of Conventional management arm and AKI sniffer instigated AKI management in Acute Kidney Injury, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-22.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Screening
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.
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).
1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.
This study's enrollment of 2,266 is above the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.
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Exclusion Criteria:
Patients with AKI receive standard of care in the conventional manner by the primary clinicians
Other: Conventional management arm
primary clinicians for the AKI patients in this arm receive a verbal alert and reminder of KDIGO guidelines.
Other: AKI sniffer instigated AKI management
Based on KDIGO guidelines and as per primary physician in the ICU
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.
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.
Time frame: baseline, 4 weeks
Plan to share: No — We plan to share IPD after initiation of patient recruitment.
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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