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CompletedNCT02879201Updated Sep 1, 2023

Continuous Venovenous Hemodiafiltration Versus Sustained Low-efficiency Hemodialysis for Critically Ill Patients With Acute Kidney Injury in Intensive Care Unit

An interventional study of Slow efficiency dialysis in Acute Kidney Injury, sponsored by Bangkok Metropolitan Administration Medical College and Vajira Hospital. Completed at 1 site in Thailand. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-09-01.

Sponsored by Bangkok Metropolitan Administration Medical College and Vajira Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Non-randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Acute Kidney Injury

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03

In context

Acute Kidney Injury

1,691 studies on the registry are indexed under Acute Kidney Injury; 395 are open to participants now.

This study's enrollment of 27 is below the median of 100 across 817 interventional studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Bangkok Metropolitan Administration Medical College and Vajira Hospital is the lead sponsor of 23 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients with pre-existing chronic kidney disease ( less than 30 mLmin/1.73m2) were excluded
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
27 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • ProcedureSlow efficiency dialysis

    Slow dialysis 4 times weekly 8 hours CVVHDF predilution mode

    Also known as: CRRT

06

What researchers measure

Primary outcomes

  1. All-cause mortality

    ll-cause mortality at 30 days following RRT initiation

    Time frame: 30 day

Secondary outcomes

  1. Numbers of patients with abnormal laboratory values

    Renal function impairment

    Time frame: 30 days

  2. ICU stay

    Total days in ICU

    Time frame: 30 days

Other outcomes

  1. Adverse events during treatment

    Number of patients with catheter infection

    Time frame: 30 days

07

Study locations

1 site
  • Renal Unit, BMA Medical College and Vajira Hospital
    Bangkok, 10300, Thailand
08

References and documents

Publications

  • 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. PubMed 12576950 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02879201
Lead sponsor
Bangkok Metropolitan Administration Medical College and Vajira Hospital
Responsible party
Thananda Trakarnvanich (Associate Professor, Bangkok Metropolitan Administration Medical College and Vajira Hospital) — Principal investigator
First posted
Aug 25, 2016
Start date
Jan 2009
Primary completion
Jun 2009
Completion
Jun 2016
Last update
Sep 1, 2023

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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