oXiris-Based Blood Purification Efficacy in Adults with Septic Shock and Acute Kidney Injury: The PURE Multicenter Pilot Randomized Clinical Trial
7 affiliations
- 1Critical Care Department, King Saud Medical City, Riyadh 11196, Saudi Arabia
- 2Department of Anesthesiology and Intensive Care, Faculty of Medicine, Tanta University, Tanta 31527, Egypt
- 3Critical Care Department, King Fahd Military Medical Complex, Dhahran 31932, Saudi Arabia
- 4Critical Care Department, Amna Inayat Medical College, Lahore 54000, Pakistan
- 5Critical Care Department, King Abdullah Specialized Hospital, National Guard Health Affairs, Buraidah 52569, Saudi Arabia
- 6Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington, KY 40506, USA
- 7Perioperative and Intensive Care, Skåne University Hospital, 222 42 Lund, Sweden
Abstract
Background/Objectives: Randomized evidence for the oXiris adsorptive membrane in septic shock remains limited. We estimated its effect on 28-day mortality and explored short-term physiologic outcomes in adults with septic shock and acute kidney injury requiring continuous renal replacement therapy. Methods: PURE was a multicenter, single-blind, parallel-group pilot randomized trial in Saudi Arabia. Participants were randomized 1:1 to oXiris-based or conventional continuous venovenous hemodialysis. The primary comparison used unadjusted mortality risk estimates. Secondary observations were summarized descriptively; adjusted and post-hoc Bayesian sensitivity analyses are reported in the main text and supplement. Results: Of 204 randomized participants, 202 were analyzed (oXiris, 100; control, 102). Twenty-eight-day mortality was 39.0% (39/100) versus 47.1% (48/102), respectively (risk ratio, 0.83; 95% CI, 0.60–1.14; risk difference, −8.1 percentage points; 95% CI, −21.7 to 5.6; p = 0.247). Reported 72 h norepinephrine dose, lactate, C-reactive protein, and Sequential Organ Failure Assessment (SOFA) score were lower with oXiris; reported intensive care unit (ICU) stay was also shorter. Secondary descriptive observations are limited by unverifiable time-specific denominators and handling of intercurrent events. Premature filter clotting was reported in 8/100 versus 7/102 participants; no device-related adverse events were reported, but safety ascertainment was limited. Conclusions: This pilot trial did not demonstrate a statistically significant reduction in 28-day mortality, although mortality was numerically lower in the oXiris group. Consistent protocol implementation and encouraging, hypothesis-generating physiologic observations provide a foundation for a definitive trial with complete longitudinal ascertainment.
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BibTeX
@article{mady2026oxirisbased,
title = {{oXiris-Based Blood Purification Efficacy in Adults with Septic Shock and Acute Kidney Injury: The PURE Multicenter Pilot Randomized Clinical Trial}},
author = {Ahmed Mady and Waleed Tharwat Aletreby and Khaled Sewify and Fahad Ali Faqihi and Rayan AlShayaa and Khaddash N. Issa and Saleh Almahwi and Jennifer Q. Gano and Adel Ali Alkenani and Ahmed Shaaban and Mohammad Al Odat and Abdullah Alquaydheb and Abdulrahman Alanazi and Basel Almuabbadi and Muhammad Asim Rana and Basheer Abdelrahman and Huda Mhawish and Amr El-Husseini and Marcus Ewert Broman},
journal = {Journal of Clinical Medicine},
year = {2026},
month = oct,
doi = {10.3390/jcm15208028},
url = {https://www.mdpi.com/2077-0383/15/20/8028},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - oXiris-Based Blood Purification Efficacy in Adults with Septic Shock and Acute Kidney Injury: The PURE Multicenter Pilot Randomized Clinical Trial
AU - Ahmed Mady
AU - Waleed Tharwat Aletreby
AU - Khaled Sewify
AU - Fahad Ali Faqihi
AU - Rayan AlShayaa
AU - Khaddash N. Issa
AU - Saleh Almahwi
AU - Jennifer Q. Gano
AU - Adel Ali Alkenani
AU - Ahmed Shaaban
AU - Mohammad Al Odat
AU - Abdullah Alquaydheb
AU - Abdulrahman Alanazi
AU - Basel Almuabbadi
AU - Muhammad Asim Rana
AU - Basheer Abdelrahman
AU - Huda Mhawish
AU - Amr El-Husseini
AU - Marcus Ewert Broman
PY - 2026
DA - 2026/10/01
JO - Journal of Clinical Medicine
DO - 10.3390/jcm15208028
UR - https://www.mdpi.com/2077-0383/15/20/8028
AB - Background/Objectives: Randomized evidence for the oXiris adsorptive membrane in septic shock remains limited. We estimated its effect on 28-day mortality and explored short-term physiologic outcomes in adults with septic shock and acute kidney injury requiring continuous renal replacement therapy. Methods: PURE was a multicenter, single-blind, parallel-group pilot randomized trial in Saudi Arabia. Participants were randomized 1:1 to oXiris-based or conventional continuous venovenous hemodialysis. The primary comparison used unadjusted mortality risk estimates. Secondary observations were summarized descriptively; adjusted and post-hoc Bayesian sensitivity analyses are reported in the main text and supplement. Results: Of 204 randomized participants, 202 were analyzed (oXiris, 100; control, 102). Twenty-eight-day mortality was 39.0% (39/100) versus 47.1% (48/102), respectively (risk ratio, 0.83; 95% CI, 0.60–1.14; risk difference, −8.1 percentage points; 95% CI, −21.7 to 5.6; p = 0.247). Reported 72 h norepinephrine dose, lactate, C-reactive protein, and Sequential Organ Failure Assessment (SOFA) score were lower with oXiris; reported intensive care unit (ICU) stay was also shorter. Secondary descriptive observations are limited by unverifiable time-specific denominators and handling of intercurrent events. Premature filter clotting was reported in 8/100 versus 7/102 participants; no device-related adverse events were reported, but safety ascertainment was limited. Conclusions: This pilot trial did not demonstrate a statistically significant reduction in 28-day mortality, although mortality was numerically lower in the oXiris group. Consistent protocol implementation and encouraging, hypothesis-generating physiologic observations provide a foundation for a definitive trial with complete longitudinal ascertainment.
SN - 2077-0383
ER -