Back to resultsEffect of the Intensity of Continuous Renal Replacement Therapy
Primary Purpose
Optimal Intensity of Renal Replacement Therapy on Sepsis Patients
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
extra high volume hemofiltration
high volume hemofiltration
Sponsored by
About this trial
This is an interventional treatment trial for Optimal Intensity of Renal Replacement Therapy on Sepsis Patients focused on measuring high volume hemofiltration, sepsis, acute kidney injury, survival
Eligibility Criteria
Inclusion Criteria:
met at least one of the following criteria: oliguria (urine output less than 100 mL in a 6 h period and unresponsive to fluid resuscitation), serum potassium concentration more than 6.5 mmol/L, severe acidemia (pH < 7.2), serum creatinine more than 250 µmol/L, or presence of severe organ edema (e.g. pulmonary edema).
Exclusion Criteria:
- were presence of a malignant tumor, chronic renal insufficiency (serum creatinine >133 µmol/L), or receiving any kind of renal replacement therapy before randomization.
Sites / Locations
- Kidney disease center, the first affiliated hospital, medical college of Zhejiang university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
extra high volume hemofiltration
high volume hemofiltration
Arm Description
extra high volume hemofiltration (85 mL/kg/h, EHVHF)
high volume hemofiltration (50 mL/kg/h, HVHF)
Outcomes
Primary Outcome Measures
90 days survival
The primary study outcome was death from any cause within 90 days. Results were analyzed by Kaplan-Meier survival curves
Secondary Outcome Measures
length of stay in the ICU and hospital
Secondary outcomes were length of stay in the ICU and hospital and renal outcome of survivors at 90 days after randomization.
Full Information
NCT ID
NCT01251081
First Posted
November 30, 2010
Last Updated
November 30, 2010
Sponsor
Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT01251081
Brief Title
Effect of the Intensity of Continuous Renal Replacement Therapy
Official Title
Effect of the Intensity of Continuous Renal Replacement Therapy in Patients With Sepsis and Acute Kidney Injury: Single-center Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2004
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Zhejiang University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In patients with sepsis and AKI, increasing the intensity of renal replacement therapy from 50 mL/kg/h (HVHF) to 85 mL/kg/h (EHVHF)will increase the survival at 28 days and 90 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Optimal Intensity of Renal Replacement Therapy on Sepsis Patients
Keywords
high volume hemofiltration, sepsis, acute kidney injury, survival
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Enrollment
280 (Actual)
8. Arms, Groups, and Interventions
Arm Title
extra high volume hemofiltration
Arm Type
Experimental
Arm Description
extra high volume hemofiltration (85 mL/kg/h, EHVHF)
Arm Title
high volume hemofiltration
Arm Type
Sham Comparator
Arm Description
high volume hemofiltration (50 mL/kg/h, HVHF)
Intervention Type
Other
Intervention Name(s)
extra high volume hemofiltration
Intervention Description
extra high volume hemofiltration (85 mL/kg/h, EHVHF)
Intervention Type
Other
Intervention Name(s)
high volume hemofiltration
Intervention Description
high volume hemofiltration (50 mL/kg/h, HVHF)
Primary Outcome Measure Information:
Title
90 days survival
Description
The primary study outcome was death from any cause within 90 days. Results were analyzed by Kaplan-Meier survival curves
Secondary Outcome Measure Information:
Title
length of stay in the ICU and hospital
Description
Secondary outcomes were length of stay in the ICU and hospital and renal outcome of survivors at 90 days after randomization.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
met at least one of the following criteria: oliguria (urine output less than 100 mL in a 6 h period and unresponsive to fluid resuscitation), serum potassium concentration more than 6.5 mmol/L, severe acidemia (pH < 7.2), serum creatinine more than 250 µmol/L, or presence of severe organ edema (e.g. pulmonary edema).
Exclusion Criteria:
were presence of a malignant tumor, chronic renal insufficiency (serum creatinine >133 µmol/L), or receiving any kind of renal replacement therapy before randomization.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jianghua chen, MD
Organizational Affiliation
Kidney disease center, the first affiliated hospital, medical college of Zhejiang university
Official's Role
Study Director
Facility Information:
Facility Name
Kidney disease center, the first affiliated hospital, medical college of Zhejiang university
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
12. IPD Sharing Statement
Learn more about this trial
Effect of the Intensity of Continuous Renal Replacement Therapy
We'll reach out to this number within 24 hrs