Back to resultsEffect of the Intensity of Continuous Renal Replacement Therapy in Patients With Acute Kidney Injury
Primary Purpose
Acute Kidney Injury
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
CRRT
Sponsored by
About this trial
This is an interventional treatment trial for Acute Kidney Injury focused on measuring CRRT, cardiac surgery associated acute kidney injury, Intensity
Eligibility Criteria
Inclusion Criteria:
- > = 18 years of age, CRRT indications for acute kidney injury (RIFLE criteria) patients with cardiac surgery
Exclusion Criteria:
- < 18 years old,
- with chronic kidney disease,
- dialysis history, to leave the ICU patients with acute kidney injury (AKI). - chronic kidney disease,
- all causes kidney damage (pathology, hematuria, and radiographic abnormalities)> = 3 months or glomerular filtration rate < 60ml/min for 3 months or more.
Sites / Locations
- Nephrology Department,Guangdong General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
high dose (35ml/kg/h)
low dose (25ml/kg/h)
Arm Description
> = 18 years of age, CRRT indications for acute kidney injury (RIFLE criteria) patients with cardiac surgery, was given filtration at a rate of 35 mL/kg/h.
> = 18 years of age, CRRT indications for acute kidney injury (RIFLE criteria) patients with cardiac surgery, was given filtration at a rate of 25 mL/kg/h.
Outcomes
Primary Outcome Measures
death from any cause
The primary study outcome was death from any cause within 14, 28 ,90 and 365 days after randomization.
Secondary Outcome Measures
renal outcome of survivors
Secondary outcomes were renal outcome of survivors14, 28 ,90 and 365 days after randomization
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01560650
Brief Title
Effect of the Intensity of Continuous Renal Replacement Therapy in Patients With Acute Kidney Injury
Official Title
Effect of the Intensity of Continuous Renal Replacement Therapy in Patients With Cardiac Surgery Associated Acute Kidney Injury (CRITERIA STUDY)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wei Shi
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The current international Continuous Renal Replacement Therapy (CRRT) replacement fluid doses of 35 ml/kg/h is better, but the result is according to white people, black people . It is Whether the best amount of replacement fluid for Chinese people, it is unclear. Especially,there is little evidence about the optimal dose from randomized trials in Cardiac surgery associated acute kidney injury (CSA-AKI )required CRRT,According to the clinical situation, the design of replacement fluid to 25 ml/kg/h.The observation of two doses 14 days, 28 days, 90 days survival and renal function.
Detailed Description
Acute kidney injury (AKI) is a major complication in patients with cardiac surgery and is an independent predictor of mortality. However, the optimal intensity of renal replacement therapy for such patients is still controversial. we randomly assigned the patients with Cardiac surgery-associated acute kidney injury (CSA-AKI) to continuous renal replacement therapy with different treatment dose (35ml / kg / h or 25ml/kg／h),The primary study outcome was death from any cause within 14, 28 and 90 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
CRRT, cardiac surgery associated acute kidney injury, Intensity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
211 (Actual)
8. Arms, Groups, and Interventions
Arm Title
high dose (35ml/kg/h)
Arm Type
Experimental
Arm Description
> = 18 years of age, CRRT indications for acute kidney injury (RIFLE criteria) patients with cardiac surgery, was given filtration at a rate of 35 mL/kg/h.
Arm Title
low dose (25ml/kg/h)
Arm Type
Experimental
Arm Description
> = 18 years of age, CRRT indications for acute kidney injury (RIFLE criteria) patients with cardiac surgery, was given filtration at a rate of 25 mL/kg/h.
Intervention Type
Device
Intervention Name(s)
CRRT
Intervention Description
Difference dose of CRRT
Primary Outcome Measure Information:
Title
death from any cause
Description
The primary study outcome was death from any cause within 14, 28 ,90 and 365 days after randomization.
Time Frame
14, 28 ,90 and 365 days after randomization
Secondary Outcome Measure Information:
Title
renal outcome of survivors
Description
Secondary outcomes were renal outcome of survivors14, 28 ,90 and 365 days after randomization
Time Frame
14, 28 ,90 and 365 days after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
> = 18 years of age, CRRT indications for acute kidney injury (RIFLE criteria) patients with cardiac surgery
Exclusion Criteria:
< 18 years old,
with chronic kidney disease,
dialysis history, to leave the ICU patients with acute kidney injury (AKI). - chronic kidney disease,
all causes kidney damage (pathology, hematuria, and radiographic abnormalities)> = 3 months or glomerular filtration rate < 60ml/min for 3 months or more.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Shi, MD, PhD
Organizational Affiliation
Guangdong Provincial People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nephrology Department,Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
12. IPD Sharing Statement
Learn more about this trial
Effect of the Intensity of Continuous Renal Replacement Therapy in Patients With Acute Kidney Injury
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