Effect of the Intensity of Continuous Renal Replacement Therapy

This study has been completed.
Sponsor:
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
  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 April 17, 2014