Back to resultsContinuous Venovenous Hemodiafiltration Versus Sustained Low-efficiency Hemodialysis for Critically Ill Patients With Acute Kidney Injury in Intensive Care Unit
Primary Purpose
Acute Kidney Injury
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Slow efficiency dialysis
Sponsored by
About this trial
This is an interventional treatment trial for Acute Kidney Injury
Eligibility Criteria
Inclusion Criteria:
- The inclusion criteria were
- AKI requiring RRT
- Hemodynamic instability defined by systolic blood pressure ≤ 90 mmHg and/or diastolic blood pressure ≤ 60 mmHg
- Patients requiring initiation to vasopressor support
Exclusion Criteria:
- Patients with pre-existing chronic kidney disease ( eGFR less than 30 mLmin/1.73m2) were excluded
Sites / Locations
- Renal Unit, BMA Medical College and Vajira Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Slow efficiency dialysis
Continuous renal replacement therapy
Arm Description
SLED is a kind of hemodialysis technique performed using Fresenius 4008B dialysis machine with FDX 120 GW (NIKKISO Japan) dialyzer. SLED sessions were 6-8 hour duration, three times per week (except Sunday), In case of severe volume overload, the session could be increased to meet clinical situation. Blood flow was maintained between 150-200 mL/hr and the dialysate flow of 300 mL/hr. Both the groups use unfractionated heparin as anticoagulant to prevent clotting of the extracorporeal circuit .the target partial thromboplastin time( PTT) was not more than twice the control level.
CRRT is a kind of therapy involved continuos dialysis throughout 24 hours by using Edward Delivery system (Edward Life Science) as continuous venovenous hemodiafiltration (CVVHDF) mode using Aquamax HF 12 dialyzer. Blood flow rate was kept from 100-200 mL/hr and target effluent rates of 20 mL/hr . The substitution fluid was infused at a rate of 1,000 ml/hr with ultrafiltration rate at 100-300 mL/hr.Intervention here is the different mode of dialysis
Outcomes
Primary Outcome Measures
All-cause mortality
ll-cause mortality at 30 days following RRT initiation
Secondary Outcome Measures
Numbers of patients with abnormal laboratory values
Renal function impairment
ICU stay
Total days in ICU
Full Information
NCT ID
NCT02879201
First Posted
July 25, 2016
Last Updated
August 31, 2023
Sponsor
Bangkok Metropolitan Administration Medical College and Vajira Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02879201
Brief Title
Continuous Venovenous Hemodiafiltration Versus Sustained Low-efficiency Hemodialysis for Critically Ill Patients With Acute Kidney Injury in Intensive Care Unit
Official Title
Continuous Venovenous Hemodiafiltration Versus Sustained Low-efficiency Hemodialysis for Critically Ill Patients With Acute Kidney Injury in Intensive Care Unit
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bangkok Metropolitan Administration Medical College and Vajira Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators conducted a comparison trial between SLED and CRRT in critically ill patients to evaluate the outcome for all cause mortality at 30 day . The secondary outcome were recovery of renal function, complications during therapy and duration of hospitalization.
Detailed Description
The investigators performed a single center experience accumulated over 12 months since February 2009 with a continuous venovenous hemodiafiltration (CVVHDF) and hybrid technique named sustained low-efficiency dialysis (SLED). The primary end point was death from any cause by day 30. Intensive care unit (ICU) patients were eligible for inclusion when serum creatinine was > 2 mg/dL, and renal replacement therapy (RRT) was initiated. The selected patients were treated with CVVHDF or SLED.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Slow efficiency dialysis
Arm Type
Active Comparator
Arm Description
SLED is a kind of hemodialysis technique performed using Fresenius 4008B dialysis machine with FDX 120 GW (NIKKISO Japan) dialyzer. SLED sessions were 6-8 hour duration, three times per week (except Sunday), In case of severe volume overload, the session could be increased to meet clinical situation. Blood flow was maintained between 150-200 mL/hr and the dialysate flow of 300 mL/hr. Both the groups use unfractionated heparin as anticoagulant to prevent clotting of the extracorporeal circuit .the target partial thromboplastin time( PTT) was not more than twice the control level.
Arm Title
Continuous renal replacement therapy
Arm Type
No Intervention
Arm Description
CRRT is a kind of therapy involved continuos dialysis throughout 24 hours by using Edward Delivery system (Edward Life Science) as continuous venovenous hemodiafiltration (CVVHDF) mode using Aquamax HF 12 dialyzer. Blood flow rate was kept from 100-200 mL/hr and target effluent rates of 20 mL/hr . The substitution fluid was infused at a rate of 1,000 ml/hr with ultrafiltration rate at 100-300 mL/hr.Intervention here is the different mode of dialysis
Intervention Type
Procedure
Intervention Name(s)
Slow efficiency dialysis
Other Intervention Name(s)
CRRT
Intervention Description
Slow dialysis 4 times weekly 8 hours CVVHDF predilution mode
Primary Outcome Measure Information:
Title
All-cause mortality
Description
ll-cause mortality at 30 days following RRT initiation
Time Frame
30 day
Secondary Outcome Measure Information:
Title
Numbers of patients with abnormal laboratory values
Description
Renal function impairment
Time Frame
30 days
Title
ICU stay
Description
Total days in ICU
Time Frame
30 days
Other Pre-specified Outcome Measures:
Title
Adverse events during treatment
Description
Number of patients with catheter infection
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- The inclusion criteria were
AKI requiring RRT
Hemodynamic instability defined by systolic blood pressure ≤ 90 mmHg and/or diastolic blood pressure ≤ 60 mmHg
Patients requiring initiation to vasopressor support
Exclusion Criteria:
Patients with pre-existing chronic kidney disease ( eGFR less than 30 mLmin/1.73m2) were excluded
Facility Information:
Facility Name
Renal Unit, BMA Medical College and Vajira Hospital
City
Bangkok
ZIP/Postal Code
10300
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
12576950
Citation
Manns B, Doig CJ, Lee H, Dean S, Tonelli M, Johnson D, Donaldson C. Cost of acute renal failure requiring dialysis in the intensive care unit: clinical and resource implications of renal recovery. Crit Care Med. 2003 Feb;31(2):449-55. doi: 10.1097/01.CCM.0000045182.90302.B3.
Results Reference
result
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Continuous Venovenous Hemodiafiltration Versus Sustained Low-efficiency Hemodialysis for Critically Ill Patients With Acute Kidney Injury in Intensive Care Unit
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