Effect of the Intensity of Continuous Renal Replacement Therapy

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

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.

Study Overview

• Status: Completed
• Conditions: Optimal Intensity of Renal Replacement Therapy on Sepsis Patients
• Intervention / Treatment: Other: extra high volume hemofiltration; Other: high volume hemofiltration

• Study Type: Interventional
• Enrollment (Actual): 280
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Kidney disease center, the first affiliated hospital, medical college of Zhejiang university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description
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

Outcome Measure	Measure Description
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.

Collaborators and Investigators

• Sponsor: Zhejiang University
• Investigators: Study Director: jianghua chen, MD, Kidney disease center, the first affiliated hospital, medical college of Zhejiang university

Study record dates

Study Major Dates

• Study Start: January 1, 2004
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: November 30, 2010
• First Submitted That Met QC Criteria: November 30, 2010
• First Posted (Estimate): December 1, 2010

Study Record Updates

• Last Update Posted (Estimate): December 1, 2010
• Last Update Submitted That Met QC Criteria: November 30, 2010
• Last Verified: January 1, 2004

More Information

Terms related to this study

• Keywords: survival; acute kidney injury; sepsis; high volume hemofiltration
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis
• Other Study ID Numbers: VHVHF