Early Continuous Renal Replacement Therapies (CRRT) in Patients With Severe Sepsis or Septic Shock With Acute Kidney Injury

Acute Kidney Injury Clinical Trial

Official title:

A Randomized Controlled Multi-Center Trial of the Early Application of CRRT in Patients With Severe Sepsis or Septic Shock

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00837057
• Other study ID #: a085068
• Status: Not yet recruiting
• Phase: Phase 4
• First received: February 4, 2009
• Last updated: February 4, 2009
• Start date: February 2009

Study information

• Verified date: January 2009
• Source: Asan Medical Center
• Contact: sangbum hong, md
• Phone: 82-2-3010-3893
• Email: sbhong[@]amc.seoul.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Severe sepsis or septic shock with acute kidney injury shows high mortality in intensive care unit. A few studies have shown CRRT relating the clinical improvement seems to be related to the early initiation of therapy. But there is no consensus for proper time of CRRT may improve the prognosis.

The study is a prospective randomized one center trial comparing two treatments in patients suffering from septic shock complicated with acute renal failure admitted to ICU, treated either early by CRRT (35 ml/kg/h) or by conventional RRT.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Septic shock (Bone criteria) for less than 14D

• RIFLE criteria : Injury or Failure or nearly anuria more than 2hr

• Age over 18 years

• Written informed consent by next of kin.

Exclusion Criteria:

• Cirrhosis child class C

• CRF or ESRD

• Too high APACHE II & SOFA score at admission

• Age over 80 years

• Life expectancy less than 3 months (metastatic cancer - hepatoma, lung ca.)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Injury
• Sepsis
• Septic Shock
• Severe Sepsis
• Shock
• Shock, Septic

Intervention

Procedure:
• crrt
early CRRT (35 ml/kg/h)& acute kidney injury or failure or nearly anuria more than 2hr or late conventional dialysis indication

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death from all causes at 28 days after randomisation		28 day	No
Secondary	Death within the in the intensive care unit. Death within 90 days of randomisation. Death prior to hospital discharge. Length of ICU stay. The need for and duration of other organ support		90 day	No