Back to results

Efficacy of Online Hemodiafiltrationlysis in Cytokine Removal

Primary Purpose

Sepsis, Acute Kidney Injury

Status

Completed

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

On-line hemodiafiltration

High-flux Hemodialysis

About this trial

This is an interventional treatment trial for Sepsis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Sepsis
acute kidney injury (RIFLE classification F)
Age more than 18

Exclusion Criteria:

Hemodynamic instability
Whom written informed consent could not be obtained

Sites / Locations

King Chulalongkorn Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

On-line hemodiafiltration

High-flux hemodialysis (control)

Arm Description

On-line hemodiafiltration is a type of renal replacement therapy that was assigned as the intervention to compare with the control arm

The standard high-flux hemodialysis is the routine renal replacement therapy in sepsis-related acute kidney injury patients and is assigned as the intervention for the control group.

Outcomes

Primary Outcome Measures

Reduction in plasma Vascular Endothelial Growth Factor (VEGF)level

Secondary Outcome Measures

Intradialytic hypotension

Renal recovery (at 30 days)

Hospital patient mortality

mortality during hospital admission

Full Information

NCT ID

NCT01791712

First Posted

October 11, 2011

Last Updated

February 12, 2013

Sponsor

Chulalongkorn University

1. Study Identification

Unique Protocol Identification Number

NCT01791712

Brief Title

Efficacy of Online Hemodiafiltrationlysis in Cytokine Removal

Official Title

Enhanced Vascular Endothelial Growth Factor and Pro-inflammatory Cytokine Clearances With On-line Hemodiafiltration Versus High-flux Hemodialysis in Sepsis-related Acute Kidney Injury Patients

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chulalongkorn University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Following the concept of "peak concentration hypothesis", which suggest the cutting peak of pro- and anti-inflammatory mediators would result in restoring a situation of immunohomeostasis. The investigators conducted the prospective randomized controlled trial aimed to compare the clearance efficacy between on-line hemodiafiltration and high-flux hemodialysis in sepsis-related acute kidney injury patients. The lowering cytokines level during sepsis is postulated to improved outcomes in sepsis.

Detailed Description

Blood samples were taken from patients before and at the end of 4-hour in the first dialysis session. The percentage of reductions were calculated from the before and ending samples. The values of postfilter samples were corrected for changes in plasma volume, based on hemoglobin (Hb) of prefilter. VEGF and other cytokines (IL-6, IL-8, IL-10, and TNF-α) were determined in the plasma separated from EDTA blood. After collection, plasma separation was achieved by centrifugation for 10 min at 1,500 g. Immediately after separation, the samples were stored at -70 ºC until further analysis. All determinations were carried out in duplicate. The panels of cytokines (VEGF, IL-6, IL-8, IL-10, and TNF-α) were measured using the Luminex xMap-based multiplex technology. Assays were performed using the MILLIPLEX MAP (multi-analyte panels) 5-plex Cytokine Kit (Millipore, Billerica, MA) on the Luminex® instrument according to the manufacturer's procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sepsis, Acute Kidney Injury

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

On-line hemodiafiltration

Arm Type

Experimental

Arm Description

On-line hemodiafiltration is a type of renal replacement therapy that was assigned as the intervention to compare with the control arm

Arm Title

High-flux hemodialysis (control)

Arm Type

Active Comparator

Arm Description

The standard high-flux hemodialysis is the routine renal replacement therapy in sepsis-related acute kidney injury patients and is assigned as the intervention for the control group.

Intervention Type

Procedure

Intervention Name(s)

On-line hemodiafiltration

Other Intervention Name(s)

Nikkiso dialysis machine, ARROW dual lumen dialysis catheter, PureFlux -150H synthetic membrane dialyzer

Intervention Description

pre-dilution 40% of blood flow rate blood flow rate 300-350 ml/min dialysate flow rate 800 ml/min

Intervention Type

Procedure

Intervention Name(s)

High-flux Hemodialysis

Intervention Description

blood flow rate 300-350 ml/min dialysate flow rate 800 ml/min

Primary Outcome Measure Information:

Title

Reduction in plasma Vascular Endothelial Growth Factor (VEGF)level

Time Frame

At time 0-hour and 4-hour of the study dialysis session

Secondary Outcome Measure Information:

Title

Intradialytic hypotension

Time Frame

During 4 hours of the study dialysis session

Title

Renal recovery (at 30 days)

Time Frame

participants will be followed for the renal recovery (dialysis-free) for the 30 days from the first initiation of dialysis

Title

Hospital patient mortality

Description

mortality during hospital admission

Time Frame

participants will be followed for the duration of hospital stay (an expected average of 5 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Sepsis acute kidney injury (RIFLE classification F) Age more than 18 Exclusion Criteria: Hemodynamic instability Whom written informed consent could not be obtained

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Khajohn Tiranathanagul, M.D.

Organizational Affiliation

Chulalongkorn University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Wiwat Chancharoenthana, M.D.

Organizational Affiliation

Chulalongkorn University

Official's Role

Principal Investigator

Facility Information:

Facility Name

King Chulalongkorn Memorial Hospital

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Online Hemodiafiltrationlysis in Cytokine Removal

We'll reach out to this number within 24 hrs