TL;DR
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The ICRAKI trial was stopped early after its monitoring board found a higher mortality signal among critically ill patients initially assigned intermittent hemodialysis than among those assigned continuous renal-replacement therapy. The study did not establish why the difference occurred, and early stopping may have made the estimated effect less precise.
The ICRAKI trial was stopped early after critically ill patients with acute kidney injury assigned to start intermittent hemodialysis had higher 90-day mortality than those assigned to continuous renal-replacement therapy, according to results reported October 14. The finding raises questions about how clinicians choose an initial dialysis approach for intensive care patients, but researchers said the reason for the mortality difference is not established.
In the trial’s intention-to-treat analysis of 535 patients, the primary outcome—a major adverse kidney event by day 90—occurred in 78.1% of patients assigned to intermittent hemodialysis and 71.6% assigned to continuous therapy. The study did not show that intermittent treatment was noninferior to continuous treatment. The trial was open-label, meaning treatment assignment was known to clinicians and participants.
Deaths by day 90 were recorded in 63.1% of the intermittent group and 53.5% of the continuous group. A time-to-event analysis estimated a 30% higher risk of death in the intermittent group (hazard ratio 1.30, 95% confidence interval 1.04 to 1.63). The trial’s data and safety monitoring board halted it after the mortality signal emerged.
The multicenter study enrolled 554 participants across intensive care units in France, rather than the planned 1,000. Assigned treatments were used for at least four consecutive days unless kidney recovery occurred; clinicians could later switch modalities. Treatment switching occurred in 21.9% of the intermittent group and 42.5% of the continuous group. Hypotension was the most common reported complication, affecting 68.8% and 66.5%, respectively.
How the Finding Could Affect ICU Dialysis
Acute kidney injury can leave critically ill patients needing renal-replacement therapy to manage fluid, electrolyte and waste levels. The choice between intermittent and continuous treatment matters because each method works differently, and patients in intensive care may be vulnerable to changes in blood pressure and fluid balance.
The mortality result is a signal for clinicians and researchers, not a settled explanation or a universal instruction to avoid intermittent hemodialysis. Researchers described the higher death rate as unexpected in light of earlier research. They said post hoc analyses suggested greater hemodynamic stress with intermittent treatment, but stressed that these exploratory findings do not establish a causal mechanism.
The result also matters because the trial enrolled patients with documented indications to begin renal-replacement therapy. The authors said the population may differ from patients in earlier trials, which took place before trial-tested criteria for starting treatment were established. That difference could affect how the new findings compare with prior evidence.
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Two Dialysis Methods, Different Trade-Offs
Intermittent hemodialysis removes toxins and corrects fluid and electrolyte imbalances more rapidly, while a single machine can be used to treat multiple patients in sequence. Its faster shifts may, however, contribute to hemodynamic instability. Continuous renal-replacement therapy removes solutes and fluid more slowly; that approach is thought to place less sudden stress on circulation, though the trial did not establish that this explains its results.
Guidelines currently suggest continuous therapy for patients who are hemodynamically unstable. In an accompanying editorial, Paul Palevsky of the Veterans Affairs Pittsburgh Healthcare System and the University of Pittsburgh School of Medicine noted that earlier randomized trials had generally found no survival difference, although comparisons have been difficult to conduct. He argued that the broader issue is how to integrate multiple available therapies into patient care, rather than treating the choice as a simple contest between methods.
ICRAKI’s treatment comparison focused on the initial period: assigned therapies were maintained for at least four days unless kidney recovery occurred, and doctors could then change approaches. The authors said the study therefore does not determine which method is preferable after the first three days, when the balance of risks and benefits may differ.
“The higher mortality in the intermittent hemodialysis group was “unexpected” based on prior literature and “not readily explained.””
— Stéphane Gaudry and colleagues, the ICRAKI investigators
What the Trial Cannot Yet Explain
The study does not show why more deaths occurred in the intermittent group, whether the difference would persist in a larger trial, or whether it applies to all ICU patients who need dialysis. Because the trial stopped before reaching its planned enrollment, its estimates may be less precise and may overstate the size of the mortality effect, the investigators said.
The reported mortality figures are specific to the enrolled population and trial treatment strategy. The study also cannot settle which modality is preferable after the initial assigned-treatment period, because clinicians could switch therapies later. The available report does not specify whether further trials are planned or how clinical guidance may change.
Further Evidence and Clinical Decisions
For now, the findings add evidence for clinicians weighing dialysis options in critically ill patients, but they do not establish a single preferred approach for every patient. Treatment decisions will continue to depend on clinical circumstances, including hemodynamic stability, and on how renal-replacement therapy is organized in each health system.
Further research would be needed to clarify whether the mortality difference is reproducible, what might account for it, and how treatment strategies should change over time. Until that evidence is available, the key next step is careful interpretation of the trial’s early-stopped results alongside prior research and the needs of individual patients.
Key Questions
Why was the ICRAKI trial stopped?
The trial’s data and safety monitoring board halted it early after a higher mortality signal appeared among patients assigned to initial intermittent hemodialysis. The study had planned to enroll 1,000 people but enrolled 554.
How did 90-day mortality differ between the groups?
Deaths by day 90 were recorded in 63.1% of the intermittent hemodialysis group and 53.5% of the continuous therapy group. The time-to-event analysis estimated a hazard ratio of 1.30, with a 95% confidence interval of 1.04 to 1.63.
Does the study prove intermittent hemodialysis caused the additional deaths?
No. The investigators said the cause of the observed difference was not readily explained. Their exploratory analyses suggested greater hemodynamic stress with intermittent treatment, but they said those findings did not establish a causal mechanism.
Does the trial show which dialysis method is best for every ICU patient?
No. The results concern the trial’s enrolled patients and initial treatment strategy. The authors said the study does not establish which method is preferable after the first three days, when clinicians could change treatment based on usual practice.
Source: rss
