AKI intervention does not achieve improvement in patient outcomes

SAN DIEGO — A strategy to improve the management of patients hospitalized with acute kidney injury (AKI), through personalized rapid referrals by a dedicated kidney action team, facilitates testing and other measures, but ultimately fails to improve clinical outcomes, a randomized, multicenter trial shows.

Although referrals from a physician and a dedicated team of pharmacists improved the rate of implementation of best practices within 24 hours, the intervention did not lead to improved patient outcomes, said lead author Abinet M. Aklilu, MD, MPH, of Yale University School of Medicine. , New Haven, Connecticut.

The study was presented at Kidney Week 2024organized by the American Society of Nephrology and published simultaneously in Journal of the American Medical Association.

While AKI affects up to 20% of hospitalized patients, the condition often goes undiagnosed, which can lead to disease progression and mortality.

Previous efforts to improve AKI outcomes with clinical decision support tools, including an intervention by the Yale team using electronic alerts for AKI, had mixed results, with various factors, including the issue of “alert fatigue,” speculated to have hindered the ultimate goal of improving patient outcomes.

“These studies were likely limited by unintended harm from alerts and limited experience and confidence in managing the diverse (nature of) AKI, where a one-size-fits-all approach will not work,” Aklilu explained.

To address some of these issues, a new intervention has been developed to add rapid real-time referrals from a dedicated kidney action team of a physician and pharmacist directly to the patient’s electronic health record.

The intervention was evaluated in a randomized, investigator-blinded trial in the Yale and Johns Hopkins hospital systems between October 2021 and February 2024.

Personalized recommendations and process outcome

Upon receiving an alert about a patient with AKI, the physician and pharmacist renal action team remotely reviewed individual patient records and provided personalized recommendations in the major categories of general diagnoses, volume, potassium, acidosis, and medications.

Patients were then randomized 1:1 to have the renal action team recommendations appear in their charts or not. The median time from automated diagnosis of AKI to randomization was 56 minutes.

In total, 4003 patients were included, with 786 (20%) in the ICU. Patients with end-stage or stage 5 renal disease chronic kidney disease (CKD), solid organ transplantation, or meeting criteria for urgent renal consultation were excluded.

Patients had a median age of 72 years, 47% were women, 23% were black, and 41% had CKD.

The average number of referrals made for patients was three, and most patients had at least one referral. The Kidney Action Team made a total of 14,539 referrals.

Regarding the outcome of the study process – defined as the proportion of referrals completed within 24 hours of randomisation – the proportion in the intervention arm of the renal action team (n = 1,999) was significantly higher at 34% compared to 24% in usual care arm ( n = 2004; p <.001).

Specific guideline interventions that were completed more frequently within 24 hours in the renal action team group included renal ultrasounds (p <.001), creatinine kinase (p = .002), bladder scan (p < 0.001), and urinalysis (p < .001).

Other areas of diagnostic and therapeutic improvement included orthostatic vitals, assessment of obstruction, documentation of AKI, and medication changes.

However, no differences were observed between those who received and those who did not receive the Kidney Action Team notes on the primary clinical outcome, a composite of AKI progression, dialysis, or mortality within 14 days (p = .28).

Also, no significant differences were observed in specific secondary outcomes, including progression of AKI (13.5% with intervention vs 13% usual care; p = .65), mortality, (9.6% vs 9.2%, respectively; p = 0.72); dialysis (1.6% vs 1.5%; p = .89) and consult nephrology (16.1% vs 14.2%; p = .09).

Key obstacles: different causes of AKI; The need for better treatments

Given the lack of change in clinical outcomes, “this study raises questions about whether early diagnostic testing, using tests commonly available in the hospital, can improve outcomes in hospitalized patients with AKI,” the authors write in the study.

Importantly, “although diagnostic recommendations (such as urinalysis) were implemented more frequently in the intervention group, testing alone may not improve outcomes,” they added.

“Follow-up, interpretation and management must follow the diagnostic tests. These activities were outside the scope of the KAT study”.

Lead author F. Perry Wilson, MD, also of Yale University School of Medicine, further speculated that key reasons may explain why clinical outcomes do not seem to change, despite “moving the needle on the detection process, diagnosis and intervention on AKI.”

Among them is the horse-out-of-the-barn hypothesis: “It may be that by the time AKI is detected (by elevated creatinine), it’s simply too late to do anything,” Wilson said. Medscape Medical News.

“Another possibility is that we simply don’t have good treatments yet,” Wilson added. “If we had a drug that worked, we could apply it, but we don’t have a (universal) drug for AKI.

“Finally, and it’s interesting to me, we found that early in AKI, it’s still very difficult to know why the patient developed AKI,” Wilson explained. “There are protean causes, and so without knowing the cause, it can be difficult even for experts to start clinicians on the right path of treatment.

“Going forward, we are very interested in measuring biomarkers in real time at the time of detection of AKI to help with this problem,” he said.

The team also plans to “assess whether recommendations targeting individuals at increased risk of severe kidney injury and specific kidney injury phenotypes lead to improved outcomes.” Aklilu noted in a press statement.

Of note, despite mixed clinical results, AKI alert systems have gained worldwide use over the past decade and are indeed required by the National Health Service in England, the authors wrote.

Commenting further on the study, Emily Chang, MD, associate professor of medicine in the Division of Nephrology and High blood pressure from the University of North Carolina, Chapel Hill, agreed that despite the failure to meet the primary results, the benefits that were seen were notable and potentially important.

“There are a lot of things that nephrologists deal with, and if our time could be saved on things like highly specialized tasks and some of these lower-level problems could be addressed differently, that would reduce our burden and burnout,” she. said Medscape Medical News.

That said, Chang added the caveat that the study excluded some patients with more severe disease. “I was a little surprised (by the lack of difference in primary clinical outcomes), but I think (it’s important that) these were less severe, milder cases, whereas the more severe ones would go to a nephrologist, and you probably . need a large number to see more of an effect.”

Wilson reports receiving research funding from Amgen, AstraZeneca, Whoop, and Vifor Pharma and consulting fees from Aura Care and Hekaheart LLC. He is a regular columnist for Medscape. Chang and Aklilu reported no relevant financial relationships.