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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02879201
Other study ID # 036/59
Secondary ID Vajira002
Status Completed
Phase N/A
First received
Last updated
Start date January 2009
Est. completion date June 2016

Study information

Verified date August 2023
Source Bangkok Metropolitan Administration Medical College and Vajira Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date June 2016
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Slow efficiency dialysis
Slow dialysis 4 times weekly 8 hours CVVHDF predilution mode

Locations

Country Name City State
Thailand Renal Unit, BMA Medical College and Vajira Hospital Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Bangkok Metropolitan Administration Medical College and Vajira Hospital

Country where clinical trial is conducted

Thailand, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Adverse events during treatment Number of patients with catheter infection 30 days
Primary All-cause mortality ll-cause mortality at 30 days following RRT initiation 30 day
Secondary Numbers of patients with abnormal laboratory values Renal function impairment 30 days
Secondary ICU stay Total days in ICU 30 days
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