Effect of the Intensity of Continuous Renal Replacement Therapy
This study has been completed.
Sponsor:
Zhejiang University
Information provided by:
Zhejiang University
ClinicalTrials.gov Identifier:
NCT01251081
First received: November 30, 2010
Last updated: NA
Last verified: January 2004
History: No changes posted
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Optimal Intensity of Renal Replacement Therapy on Sepsis Patients |
Other: extra high volume hemofiltration Other: high volume hemofiltration |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Effect of the Intensity of Continuous Renal Replacement Therapy in Patients With Sepsis and Acute Kidney Injury: Single-center Randomized Clinical Trial |
Resource links provided by NLM:
Further study details as provided by Zhejiang University:
Primary Outcome Measures:
- 90 days survival [ Designated as safety issue: No ]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 [ Designated as safety issue: No ]Secondary outcomes were length of stay in the ICU and hospital and renal outcome of survivors at 90 days after randomization.
| Enrollment: | 280 |
| Study Start Date: | January 2004 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: extra high volume hemofiltration
extra high volume hemofiltration (85 mL/kg/h, EHVHF)
|
Other: extra high volume hemofiltration
extra high volume hemofiltration (85 mL/kg/h, EHVHF)
|
|
Sham Comparator: high volume hemofiltration
high volume hemofiltration (50 mL/kg/h, HVHF)
|
Other: high volume hemofiltration
high volume hemofiltration (50 mL/kg/h, HVHF)
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01251081
Locations
| China, Zhejiang | |
| Kidney disease center, the first affiliated hospital, medical college of Zhejiang university | |
| Hangzhou, Zhejiang, China, 310003 | |
Sponsors and Collaborators
Zhejiang University
Investigators
| Study Director: | jianghua chen, MD | Kidney disease center, the first affiliated hospital, medical college of Zhejiang university |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT01251081 History of Changes |
| Other Study ID Numbers: | VHVHF |
| Study First Received: | November 30, 2010 |
| Last Updated: | November 30, 2010 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Zhejiang University:
|
high volume hemofiltration sepsis acute kidney injury survival |
Additional relevant MeSH terms:
|
Acute Kidney Injury Sepsis Toxemia Renal Insufficiency Kidney Diseases |
Urologic Diseases Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |
ClinicalTrials.gov processed this record on May 21, 2013