Efficacy of hybrid blood purification for SA-AKI subtypes identified by CCL14: study protocol for a single-centre randomized controlled clinical trial.

2025-08-26
Trials 26(1)
- Keran Shi
- Wei Jiang
- Lin Song
- Xianghui Li
- Jing Wang
- Renyan Zhao
- Haixia Wang
- Fan Sun
- Ran Wang
- Cenlu Pu
- Chuanqing Zhang
- Luanluan Li
- Yunfan Feng
- Jiangquan Yu
- Ruiqiang Zheng

PubMed: 40859313
DOI: 10.1186/s13063-025-09058-4

Study Design

Type: Randomized Controlled Trial (RCT)
Population: critically ill patients with sepsis-associated acute kidney injury (SA-AKI) identified by CCL14
Methods: single-center, blinded, randomized controlled trial; patients randomly assigned to continuous veno-venous hemofiltration (CVVH) group or hybrid blood purification (HBP) group
Blinding: Single-blind
Funding: Unclear

Background

Sepsis-associated acute kidney injury (SA-AKI) is a commonly encountered complex heterogeneous syndrome in critically ill patients with sepsis. Under the interaction of genotype and pathogenic factors, SA-AKI can lead to various clinical phenotypes and subphenotypes, and this heterogeneity complicates the assessment of the efficacy of treatment measures for sepsis in clinical trials. Early identification of SA-AKI high-risk patients with specific subphenotypes and timely implementation of supportive treatments may improve adverse outcomes for these patients. High levels of C-C motif chemokine ligand 14 (CCL14) serve as a biomarker that can early identify critically ill patients with persistent SA-AKI. However, the effects of different supportive treatment strategies on the prognosis of SA-AKI patients identified by CCL14 remain unclear. We hypothesize that integrated blood purification (HBP) therapy has a beneficial effect in the treatment of SA-AKI identified by CCL14.

Methods

This is a single-center, blinded, randomized controlled trial. After the patients were admitted to the ICU, blood and urine samples were taken, and the urine CCL14 concentration was measured. Subsequently, they were randomly assigned to the continuous veno-venous hemofiltration (CVVH) group and the hybrid blood purification (HBP) group. The HBP group received blood hemoperfusion (HP) treatment using the HA380 hemoperfusion filter (Jafron, China) and CVVH treatment using the AN69 ST100 blood filter (Baxter, USA). The CVVH group used only the AN69 ST100 blood filter (Baxter, USA) and selected the CVVH mode for continuous renal replacement therapy (CRRT). The primary outcome was the all-cause mortality rate at 30 days after enrollment. The secondary outcomes included the all-cause mortality rate at 90 days, the incidence of chronic kidney disease (CKD) within 90 days, changes in kidney function 72 h after enrollment, variations in endotoxin levels, changes in coagulation function parameters, alterations in inflammatory factor levels, changes in plasma endothelial barrier-related indicators, variations in hemodynamic parameters, changes in SOFA (Sequential (Sepsis-related) Organ Failure Assessment) score, changes in Apache II score, duration of kidney replacement therapy (KRT) during hospitalization, duration of mechanical ventilation, duration of stay in ICU, and duration of stay in hospital.

Discussion

This study aims to explore the impact of the HBP therapy on the 30-day all-cause mortality rate of patients with SA-AKI subtypes recognized by CCL14, providing relatively reliable research evidence for determining the optimal treatment approach for patients with persistent severe SA-AKI in clinical practice.

Trial registration

Chinese Clinical Trial Registry (CHICTR), ChiCTR2400093572. Registered on 9 December 2024, https://www.chictr.org.cn/showproj.html?proj=241688.