NCT02879201

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 25, 2016

Completed
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

5 months

First QC Date

July 25, 2016

Last Update Submit

August 31, 2023

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    ll-cause mortality at 30 days following RRT initiation

    30 day

Secondary Outcomes (2)

  • Numbers of patients with abnormal laboratory values

    30 days

  • ICU stay

    30 days

Other Outcomes (1)

  • Adverse events during treatment

    30 days

Study Arms (2)

Slow efficiency dialysis

ACTIVE COMPARATOR

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

Continuous renal replacement therapy

NO INTERVENTION

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

Slow efficiency dialysisPROCEDURE

Slow dialysis 4 times weekly 8 hours CVVHDF predilution mode

Also known as: CRRT
Slow efficiency dialysis

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renal Unit, BMA Medical College and Vajira Hospital

Bangkok, 10300, Thailand

Location

Related Publications (1)

  • 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.

    PMID: 12576950RESULT

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 25, 2016

First Posted

August 25, 2016

Study Start

January 1, 2009

Primary Completion

June 1, 2009

Study Completion

June 1, 2016

Last Updated

September 1, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)