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

NCT ID: NCT02879201

Last Updated: 2023-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2016-06-30

Brief Summary

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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

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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.

Conditions

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Acute Kidney Injury

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Slow efficiency dialysis

Intervention Type PROCEDURE

Slow dialysis 4 times weekly 8 hours CVVHDF predilution mode

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Slow efficiency dialysis

Slow dialysis 4 times weekly 8 hours CVVHDF predilution mode

Intervention Type PROCEDURE

Other Intervention Names

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CRRT

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bangkok Metropolitan Administration Medical College and Vajira Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Thananda Trakarnvanich

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Renal Unit, BMA Medical College and Vajira Hospital

Bangkok, , Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type RESULT
PMID: 12576950 (View on PubMed)

Other Identifiers

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Vajira002

Identifier Type: REGISTRY

Identifier Source: secondary_id

036/59

Identifier Type: -

Identifier Source: org_study_id

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