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

NCT00837057 | Unknown Phase 4

• 1 other identifier: a085068
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Severe Sepsis; Septic Shock; Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Death from all causes at 28 days after randomisation

  28 day

Secondary Outcomes (1)

• 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

Study Arms (1)

early crrt, late crrt

OTHER

Procedure: crrt

Interventions

crrt PROCEDURE

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

Also known as: renal replacement therapy, timing

early crrt, late crrt

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Related Publications (1)

• Fayad AI, Buamscha DG, Ciapponi A. Timing of kidney replacement therapy initiation for acute kidney injury. Cochrane Database Syst Rev. 2022 Nov 23;11(11):CD010612. doi: 10.1002/14651858.CD010612.pub3.

  PMID: 36416787 DERIVED

MeSH Terms

Conditions

Sepsis; Shock, Septic; Acute Kidney Injury

Interventions

Continuous Renal Replacement Therapy; Renal Replacement Therapy

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Central Study Contacts

sangbum hong, md

CONTACT

82-2-3010-3893; sbhong@amc.seoul.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 4, 2009
• First Posted: February 5, 2009
• Study Start: February 1, 2009
• Primary Completion: January 1, 2011
• Last Updated: February 5, 2009

Record last verified: 2009-01

Locations

KR (1)