Effect of the Intensity of Continuous Renal Replacement Therapy

Optimal Intensity of Renal Replacement Therapy on Sepsis Patients Clinical Trial

Official title:

Effect of the Intensity of Continuous Renal Replacement Therapy in Patients With Sepsis and Acute Kidney Injury: Single-center Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01251081
• Other study ID #: VHVHF
• Status: Completed
• Phase: N/A
• First received: November 30, 2010
• Last updated: November 30, 2010
• Start date: January 2004
• Est. completion date: June 2010

Study information

• Verified date: January 2004
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: June 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Injury
• Optimal Intensity of Renal Replacement Therapy on Sepsis Patients
• Sepsis

Intervention

Other:
• extra high volume hemofiltration
extra high volume hemofiltration (85 mL/kg/h, EHVHF)
• high volume hemofiltration
high volume hemofiltration (50 mL/kg/h, HVHF)

Locations

Country	Name	City	State
China	Kidney disease center, the first affiliated hospital, medical college of Zhejiang university	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	90 days survival	The primary study outcome was death from any cause within 90 days. Results were analyzed by Kaplan-Meier survival curves		No
Secondary	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.		No