A multi-center cross-sectional study on blood purification among adult patients in intensive care unit in China: a study protocol

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A multi-center cross-sectional study on blood purification among adult patients in intensive care unit in China: a study protocol

Acute kidney injury (AKI) is often called a “silent killer” in intensive care units (ICUs)—it’s common, deadly, and hard to spot early. For critically ill patients, blood purification (BP)—a set of therapies that filter toxins, excess fluid, or harmful molecules from the blood—is a lifeline. But how do hospitals across China actually use this life-saving tool? A 2019 study protocol from researchers at Harbin Medical University outlines a landmark effort to answer that question—and lay the groundwork for standardized care.

Led by Yang Gao, Zhi-Dong Qi, and Kai-Jiang Yu from Harbin Medical University’s Second Affiliated Hospital, Cancer Hospital, and First Affiliated Hospital, the study is the first large-scale attempt to map real-world BP practice in Chinese ICUs. The goal? To reveal gaps, variations, and best practices that could inform national guidelines—something China currently lacks for BP.

Why This Study Matters

AKI affects up to 20% of ICU patients worldwide, according to a 2013 meta-analysis in Clinical Journal of the American Society of Nephrology. Of those, 1 in 5 need BP—a demand that’s growing as ICU care expands. But BP isn’t just for AKI: it’s used to treat septic shock, drug poisoning, liver failure, and life-threatening electrolyte imbalances, too. The problem? There’s no clear guidance on when to start BP, which type to use, or how to manage it safely. This leads to huge differences in care: a patient in Beijing might get continuous hemofiltration for AKI, while someone in a rural hospital gets intermittent hemodialysis—or no BP at all.

For China, this is a critical issue. As the world’s most populous country, it has 2.6 million ICU beds (2020 data) and a growing burden of AKI. A 2015 Lancet study found that AKI affects 1.2 million Chinese hospital patients annually—yet it’s often underdiagnosed and undertreated in rural areas. Standardizing BP could save thousands of lives.

How the Study Was Designed

The study is a multi-center cross-sectional survey—meaning it looked at BP use across many hospitals at one time. Here’s the breakdown:

  • Centers: 35 hospitals in 23 provinces, 4 municipalities (Beijing, Shanghai, Tianjin, Chongqing), and 5 autonomous regions. Beijing, Shanghai, and Guangzhou each included 2 top-tier tertiary hospitals to account for regional differences.
  • Participants: Adult patients (18+) admitted to ICU who needed BP between 2018–2019. If a patient was readmitted to ICU during the 30-day survey, they were enrolled again.
  • Exclusions: Patients without written consent or incomplete medical records.
  • Data Collected: The team tracked every step of BP care:
    • When BP was started (early vs. late)
    • Why it was used (AKI vs. non-AKI conditions like sepsis or poisoning)
    • Type of BP (intermittent hemodialysis, continuous venovenous hemofiltration, hemoperfusion, etc.)
    • How vascular access was established (central venous catheter vs. other methods)
    • Filter/membrane type (polyethersulfone, polysulfone, etc.)
    • Anticoagulation (heparin vs. citrate vs. no anticoagulation)
    • Who ran the therapy (ICU team vs. nephrology department)
    • Complications (bleeding, clotting, infection)
    • Fluid intake/output (critical for managing overload)
  • Scores: They used three standard ICU tools—APACHE II (to measure illness severity), SOFA (organ failure), and GCS (consciousness)—to link BP practice to patient outcomes.

Sample Size: Why 369 Patients?

The team calculated they needed at least 369 patients to get reliable results. Here’s how:

  1. They assumed a 2% “population rate” of BP use (based on prior studies).
  2. Using a formula for large populations, they estimated 6,147 total ICU patients would need to be screened.
  3. Of those, 20% (1,229) would have AKI (per a 2013 Kidney International study).
  4. Of AKI patients, 15% (184) would need renal replacement therapy (RRT)—a common type of BP.
  5. To account for non-AKI uses of BP, they doubled that number to 369.

Ethics and Transparency

The study followed strict ethical rules:

  • Approved by the Ethics Committee of Harbin Medical University’s Cancer Hospital (No. KY2017-22).
  • Followed the Declaration of Helsinki (the global gold standard for medical research).
  • Required written consent from patients or their legal representatives.
  • Kept patient data confidential.

What Comes Next?

The survey was completed in 2019, and the results are pending publication. But the protocol itself is a big step: it’s the first detailed plan to document BP practice in China. If the study finds, for example, that most hospitals start BP too late for AKI patients—or that rural centers lack access to continuous BP therapies—those insights could drive policy changes.

For clinicians, this study could mean clearer rules on when to start BP, which filters to use, or how to prevent complications. For patients, it could mean more consistent, life-saving care.

Gao Y, Qi ZD, Liu RJ, et al. A multi-center cross-sectional study on blood purification among adult patients in intensive care unit in China: a study protocol. Chinese Medical Journal 2019;132(10):1208–1211. doi:10.1097/CM9.0000000000000180

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