Effect of the Intensity of Continuous Renal Replacement Therapy in Patients With Acute Kidney Injury

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wei Shi, Guangdong General Hospital
ClinicalTrials.gov Identifier:
NCT01560650
First received: March 20, 2012
Last updated: January 17, 2016
Last verified: January 2016
  Purpose
The current international Continuous Renal Replacement Therapy (CRRT) replacement fluid doses of 35 ml/kg/h is better, but the result is according to white people, black people . It is Whether the best amount of replacement fluid for Chinese people, it is unclear. Especially,there is little evidence about the optimal dose from randomized trials in Cardiac surgery associated acute kidney injury (CSA-AKI )required CRRT,According to the clinical situation, the design of replacement fluid to 25 ml/kg/h.The observation of two doses 14 days, 28 days, 90 days survival and renal function.

Condition Intervention Phase
Acute Kidney Injury
Device: CRRT
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of the Intensity of Continuous Renal Replacement Therapy in Patients With Cardiac Surgery Associated Acute Kidney Injury (CRITERIA STUDY)

Resource links provided by NLM:


Further study details as provided by Guangdong General Hospital:

Primary Outcome Measures:
  • death from any cause [ Time Frame: 14, 28 ,90 and 365 days after randomization ] [ Designated as safety issue: Yes ]
    The primary study outcome was death from any cause within 14, 28 ,90 and 365 days after randomization.


Secondary Outcome Measures:
  • renal outcome of survivors [ Time Frame: 14, 28 ,90 and 365 days after randomization ] [ Designated as safety issue: Yes ]
    Secondary outcomes were renal outcome of survivors14, 28 ,90 and 365 days after randomization


Enrollment: 211
Study Start Date: March 2011
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: high dose (35ml/kg/h)
> = 18 years of age, CRRT indications for acute kidney injury (RIFLE criteria) patients with cardiac surgery, was given filtration at a rate of 35 mL/kg/h.
Device: CRRT
Difference dose of CRRT
Experimental: low dose (25ml/kg/h)
> = 18 years of age, CRRT indications for acute kidney injury (RIFLE criteria) patients with cardiac surgery, was given filtration at a rate of 25 mL/kg/h.
Device: CRRT
Difference dose of CRRT

Detailed Description:
Acute kidney injury (AKI) is a major complication in patients with cardiac surgery and is an independent predictor of mortality. However, the optimal intensity of renal replacement therapy for such patients is still controversial. we randomly assigned the patients with Cardiac surgery-associated acute kidney injury (CSA-AKI) to continuous renal replacement therapy with different treatment dose (35ml / kg / h or 25ml/kg/h),The primary study outcome was death from any cause within 14, 28 and 90 days.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • > = 18 years of age, CRRT indications for acute kidney injury (RIFLE criteria) patients with cardiac surgery

Exclusion Criteria:

  • < 18 years old,
  • with chronic kidney disease,
  • dialysis history, to leave the ICU patients with acute kidney injury (AKI). - chronic kidney disease,
  • all causes kidney damage (pathology, hematuria, and radiographic abnormalities)> = 3 months or glomerular filtration rate < 60ml/min for 3 months or more.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01560650

Locations
China, Guangdong
Nephrology Department,Guangdong General Hospital
Guangzhou, Guangdong, China
Sponsors and Collaborators
Wei Shi
Investigators
Principal Investigator: Wei Shi, MD, PhD Guangdong General Hospital
  More Information

Responsible Party: Wei Shi, Director of renal division of Guangdong General Hospital, Guangdong General Hospital
ClinicalTrials.gov Identifier: NCT01560650     History of Changes
Other Study ID Numbers: LXL-CRRT2535 
Study First Received: March 20, 2012
Last Updated: January 17, 2016
Health Authority: China: Ethics Committee

Keywords provided by Guangdong General Hospital:
CRRT
cardiac surgery associated acute kidney injury
Intensity

Additional relevant MeSH terms:
Acute Kidney Injury
Kidney Diseases
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on May 25, 2016