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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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ClinicalTrials.gov Identifier: NCT02879201
Recruitment Status : Completed
First Posted : August 25, 2016
Last Update Posted : August 25, 2016
Sponsor:
Information provided by (Responsible Party):
Thananda Trakarnvanich, Bangkok Metropolitan Administration Medical College and Vajira Hospital

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.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Procedure: Slow efficiency dialysis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Continuous Venovenous Hemodiafiltration Versus Sustained Low-efficiency Hemodialysis for Critically Ill Patients With Acute Kidney Injury in Intensive Care Unit
Study Start Date : January 2009
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Active Comparator: Slow efficiency dialysis
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.
Procedure: Slow efficiency dialysis
Slow dialysis 4 times weekly 8 hours CVVHDF predilution mode
Other Name: CRRT

No Intervention: Continuous renal replacement therapy
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



Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 30 day ]
    ll-cause mortality at 30 days following RRT initiation


Secondary Outcome Measures :
  1. Numbers of patients with abnormal laboratory values [ Time Frame: 30 days ]
    Renal function impairment

  2. ICU stay [ Time Frame: 30 days ]
    Total days in ICU


Other Outcome Measures:
  1. Adverse events during treatment [ Time Frame: 30 days ]
    Number of patients with catheter infection



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- The inclusion criteria were

  1. AKI requiring RRT
  2. Hemodynamic instability defined by systolic blood pressure ≤ 90 mmHg and/or diastolic blood pressure ≤ 60 mmHg
  3. Patients requiring initiation to vasopressor support

Exclusion Criteria:

  • Patients with pre-existing chronic kidney disease ( eGFR less than 30 mLmin/1.73m2) were excluded

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02879201


Locations
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Thailand
Renal Unit, BMA Medical College and Vajira Hospital
Bangkok, Thailand, 10300
Sponsors and Collaborators
Bangkok Metropolitan Administration Medical College and Vajira Hospital
Publications of Results:
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Responsible Party: Thananda Trakarnvanich, Associate Professor, Bangkok Metropolitan Administration Medical College and Vajira Hospital
ClinicalTrials.gov Identifier: NCT02879201    
Other Study ID Numbers: 036/59
Vajira002 ( Registry Identifier: SLED )
First Posted: August 25, 2016    Key Record Dates
Last Update Posted: August 25, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases