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The ICRAKI trial was stopped early after an independent monitoring board identified higher mortality among critically ill patients initially assigned intermittent hemodialysis than among those assigned continuous renal-replacement therapy. At 90 days, deaths were reported in 63.1% of the intermittent group and 53.5% of the continuous group; researchers said the unexpected difference has no established explanation and that early stopping may affect the estimate.
A randomized trial of dialysis approaches for critically ill patients with acute kidney injury was stopped early after an independent monitoring board found a higher mortality signal among patients initially assigned intermittent hemodialysis than among those assigned continuous renal-replacement therapy. By day 90, deaths had occurred in 63.1% of the intermittent group and 53.5% of the continuous group, according to results published in the New England Journal of Medicine.
The ICRAKI trial compared the two methods in patients in French intensive care units who had acute kidney injury and documented indications for renal-replacement therapy. In its intention-to-treat analysis of 535 patients, the trial’s primary outcome—a major adverse kidney event by day 90—occurred in 78.1% of those assigned intermittent treatment and 71.6% of those assigned continuous treatment. The study reported that intermittent hemodialysis did not establish noninferiority to continuous therapy.
The mortality comparison was also higher in the intermittent arm. Kaplan-Meier estimates indicated a 30% higher relative risk of death with intermittent treatment (hazard ratio 1.30, 95% confidence interval 1.04-1.63). The trial had been planned to enroll 1,000 people but enrolled 554 overall before it was halted; the primary analysis included 535. Researchers cautioned that stopping early can reduce the precision of treatment-effect estimates and may make the observed mortality difference appear larger.
Patients were assigned to their initial approach for at least four consecutive days unless their kidneys recovered, after which clinicians could switch therapies. Switching occurred in 21.9% of the intermittent group and 42.5% of the continuous group. Treatment lasted a median of five days in the intermittent arm and seven in the continuous arm. Hypotension was the most common reported complication, occurring in 68.8% and 66.5%, respectively.
Implications for ICU Dialysis Choices
The results matter because clinicians must choose how to provide kidney support to patients who are already critically ill, and the two approaches differ in speed and intensity. Intermittent hemodialysis can remove toxins and correct fluid or electrolyte problems quickly, but rapid shifts may place stress on circulation. Continuous therapy removes fluid and solutes more gradually and is often used for patients with hemodynamic instability.
The trial raises concern about starting with intermittent treatment in the population it studied, but it does not settle every bedside decision. The researchers said the higher mortality was unexpected and not readily explained. Their exploratory analyses suggested greater hemodynamic stress with intermittent treatment, but they explicitly cautioned that these analyses do not establish a cause. The findings also do not determine which method is best after the initial treatment period.
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How the Trial Compared Dialysis
Earlier randomized studies comparing intermittent and continuous renal-replacement therapy had generally found no survival difference, according to an accompanying editorial by Paul Palevsky of the Veterans Affairs Pittsburgh Healthcare System and the University of Pittsburgh School of Medicine. He noted that such trials have been difficult to conduct. ICRAKI differed in enrolling patients with documented indications for renal-replacement therapy, rather than relying on the approaches used in some earlier studies conducted before trial-based initiation criteria were established.
The trial involved adults treated in French ICUs from October 2023 through July 2025. Most participants were admitted for medical rather than surgical reasons. About half had acute respiratory distress syndrome at baseline, and more than 70% were receiving invasive mechanical ventilation at ICU admission. The results therefore concern a severely ill ICU population and should not automatically be applied to patients with different levels of illness or different treatment circumstances.
In his editorial, Palevsky described a practical distinction between health systems: some provide nearly all ICU renal-replacement therapy continuously and switch patients to intermittent treatment when they are ready to leave intensive care, while others have both options available and tend to use continuous therapy for patients with greater hemodynamic instability. He argued that comparing these broader care strategies is not the same as comparing only the initial dialysis method.
“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
Limits of the Mortality Finding
The results do not show why deaths were more frequent in the intermittent-treatment group, and the proposed hemodynamic explanation remains exploratory rather than proven. The researchers also warned that the early stop may have affected the size and precision of the estimated effect. While the primary analysis included 535 patients, total enrollment was 554, and the study had originally aimed for 1,000.
The comparison is focused on initial treatment. After at least four consecutive days, clinicians could change modalities, and switching was more common in the continuous arm. The trial therefore does not establish which treatment is preferable after the first three days, when patients’ condition and the balance of potential benefits and risks may differ. The findings also do not establish that one method is superior for every patient with acute kidney injury.
Questions for Future ICU Studies
The next steps for clinicians and researchers include examining the mortality signal in further studies and clarifying which patients may benefit from each approach. The ICRAKI results alone do not identify a causal mechanism or determine how treatment should be managed beyond the initial period. Researchers have not provided a subsequent trial timetable in the reported material.
For now, the study adds new evidence to a long-standing debate about dialysis choices in intensive care. Decisions remain tied to a patient’s condition and local care practices, while the trial’s findings warrant attention alongside its early stopping, treatment switching and limits on conclusions about later therapy.
Key Questions
What happened in the ICRAKI trial?
The trial comparing initial intermittent hemodialysis with continuous renal-replacement therapy in critically ill patients with acute kidney injury was stopped early after a higher mortality signal appeared in the intermittent-treatment group.
How did deaths compare by day 90?
Deaths had occurred in 63.1% of the intermittent group and 53.5% of the continuous group by day 90. The reported Kaplan-Meier estimate was a hazard ratio of 1.30, with a 95% confidence interval of 1.04-1.63.
Does the study explain why mortality was higher?
No. The investigators said the difference was unexpected and not readily explained. Exploratory analyses suggested greater hemodynamic stress with intermittent hemodialysis, but they said those findings do not establish a cause.
Does the trial show that continuous therapy is best for every patient?
No. The findings apply to the studied ICU population and initial treatment assignment. They do not establish that one method is best for every patient or identify the preferred approach after the initial treatment period.
Why was the trial stopped early?
The data and safety monitoring board halted the trial after a higher mortality signal emerged in the intermittent-treatment group. The researchers said early stopping was ethically justified but may have reduced the precision of estimates and made the observed effect appear larger.
Source: rss
