Comparison Cytokine Clearance Between SLED-f Using High Cut-off Dialyzer and High-flux Dialyzer in Septic AKI Patients

NCT03014232 | Completed

• 1 other identifier: 271/54
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

Hypercytokinemia contributes a major role in the pathogenesis and is associated with the high mortality in sepsis-related acute kidney injury(AKI). This pilot randomized controlled trial was conducted in sepsis-related AKI patients to compare the efficacy of cytokine removal including interleukin(IL)-6, IL-8, IL-10, and tumor necrotic factor(TNF)-α by six-hour SLED-f between using HCO dialyzer(HCO-SLED-f) and HF dialyzer(HF-SLED-f).

Conditions

Sepsis; Acute Kidney Injury

Keywords

sustained low-efficiency diafiltration (SLED-f); high cut-off dialyzer; cytokines

Outcome Measures

Primary Outcomes (1)

• IL-6 Clearance

  Simultaneous pre-and post-dialyzer blood samples from arterial and venous sampling ports were collected at 30 minutes after the treatment was started for determination of dialyzer clearances.

  At 30 minutes after the treatment was started

Secondary Outcomes (6)

• Urea percentage of reduction ratio

  At time 0-hour and 6-hour of the study SLED-f session

• Beta2-microglobulin percentage of reduction ratio

  At time 0-hour and 6-hour of the study SLED-f session

• IL-10 Clearances

  At 30 minutes after the treatment was started

• TNF-α Clearances

  At 30 minutes after the treatment was started

• Intradialytic hypotension

  During 6 hours of SLED-f session

Study Arms (2)

SLED-f with HCO dialyzer

EXPERIMENTAL

Online sustained low-efficiency diafiltration (online SLED-f) using novel high cut-off dialyzer which had larger pore size than standard high-flux dialyzer was assigned as the new intervention to compare the efficacy of cytokine removals with the control arm.

Procedure: SLED-f with HCO dialyzer

SLED-f with HF dialyzer

ACTIVE COMPARATOR

Online sustained low-efficiency diafiltration (online SLED-f) using standard high-flux dialyzer in septic acute kidney injury patients was assigned as the control group

Procedure: SLED-f with HF dialyzer

Interventions

SLED-f with HCO dialyzer PROCEDURE

Online SLED-f with high cut-off dialyzers were performed using the Fresenius 5008S hemodiafiltration machines (Fresenius Medical Care, Bad Homburg, Germany). Super-flux, Sureflux 150FH (Nipro Corporation, Osaka, Japan; cellulose triacetate material, pore size 78 A◦, Kuf 66.9 mL/hr/mmHg, surface area 1.5 m2) were used. Dialysis time and blood flow rate were 6 hours and 200 mL/min, respectively. The predilution reinfusion fluid rate and dialysate flow rate were 80 and 220 mL/min, respectively (the total dialysis fluid flow rate was 300 mL/min).

SLED-f with HCO dialyzer

SLED-f with HF dialyzer PROCEDURE

Online SLED-f with standard high-flux dialyzers were performed using the same Fresenius 5008S hemodiafiltration machines (Fresenius Medical Care, Bad Homburg, Germany). High-flux ELISIO 150H (Nipro Corporation, Osaka, Japan; polynephron material, pore size 50-60 A◦, Kuf 67 mL/hr/mmHg, surface area 1.5 m2) were used. Dialysis time and blood flow rate were 6 hours and 200 mL/min, respectively. The predilution reinfusion fluid rate and dialysate flow rate were 80 and 220 mL/min, respectively (the total dialysis fluid flow rate was 300 mL/min).

SLED-f with HF dialyzer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sepsis
• Acute kidney injury stage 3

You may not qualify if:

• Profound hemodynamic instability with more than one inotropic drug
• Pregnancy
• Breast-feeding
• Delayed receiving antibiotic up to 6 hours after beginning of septic shock.

Sponsors & Collaborators

• Chulalongkorn University: lead

MeSH Terms

Conditions

Sepsis; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Khajohn Tiranathanagul, MD

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

• Jeeraluk Tunpornchai, MD

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 9, 2017
• Study Start: June 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: January 9, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share