Hybrid Blood Purification for SA-AKI: A Clinical Trial Protocol
Summary of the Study Protocol: Hemodynamic Blood Purification vs. Continuous Veno-Venous Hemofiltration in Sepsis
This document outlines the protocol for a randomized controlled trial comparing hemodynamic Blood Purification (HBP) to Continuous Veno-Venous Hemofiltration (CVVH) in patients with sepsis. Here’s a breakdown of the key aspects:
1. Study Design:
Type: Randomized, controlled, single-center trial.
Groups:
HBP Group (Experimental): Receives Hemodynamic Blood Purification.
CVVH Group (Control): Receives Continuous Veno-Venous Hemofiltration.
Sample Size: 95 participants per group (total of 190), accounting for a 10% loss to follow-up/refusal rate.
2. Participants:
Inclusion Criteria: (Not explicitly listed,but implied to be patients diagnosed with sepsis meeting specific criteria – further details would be in the full protocol).
Exclusion Criteria: (Not explicitly listed, but implied to be patients with specific contraindications to either HBP or CVVH – further details would be in the full protocol).
3. Interventions:
HBP: Hemodynamic Blood Purification (details of the specific protocol not provided).
CVVH: Continuous Veno-Venous Hemofiltration (standard treatment).
4. Data Collection & Measurements:
Timepoints: Enrollment and 72 hours post-enrollment.
Samples: Blood and urine samples collected at each timepoint.
Measured Parameters:
Clinical data: Collected via Case Report Forms (CRFs) and managed on the ResMan website.
Biomarkers (Blood):
CCL14 concentration
Vascular endothelial barrier-related indicators: Syndecan-1, E-selectin, Ang-2, VE-cadherin, Claudin-5
Endotoxin content (using LAL assay)
Sepsis Infection Status:
Site of infection (multiple options listed)
Culture results (Gram-positive, Gram-negative, fungi, viruses, no results)
types of pathogens (specific bacteria and Candida listed, plus “other pathogens”)
Urine: CCL14 concentration
5. Outcome Measures:
Primary Outcome: 30-day all-cause mortality rate.
Secondary Outcomes: (Not explicitly listed, but likely include changes in biomarkers, clinical parameters, and possibly adverse events).
6. Data Management & Monitoring:
Data Collection: Using CRFs and ResMan website.
Data Monitoring: Conducted by the research team led by the principal investigator (no external Data Monitoring Commitee needed due to single-center design).
Stopping Rules: Trial can be terminated by the principal investigator if important adverse events occur in the HBP group or if early results indicate flaws in the CVVH group.
7. Blinding:
Operators performing the biomarker and endotoxin assays are blinded to the experimental research content.8. Sample Size Justification:
* Based on a power analysis using literature data (mortality rates of 0.71 for HBP and 0.82 for CVVH) to detect a clinically meaningful difference of 0.1 in mortality rates, with α=0.05 and power=0.9.
In essence, this study aims to determine if HBP is superior to CVVH in reducing mortality in sepsis patients, and to investigate the impact of each treatment on vascular endothelial barrier function and inflammatory markers.