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

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ClinicalTrials.gov Identifier: NCT01560650
Recruitment Status : Completed
First Posted : March 22, 2012
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Acute Kidney Injury Device: CRRT Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 211 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : March 2011
Primary Completion Date : August 2015
Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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


Secondary Outcome Measures :
  1. renal outcome of survivors [ Time Frame: 14, 28 ,90 and 365 days after randomization ]
    Secondary outcomes were renal outcome of survivors14, 28 ,90 and 365 days after randomization


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: March 22, 2012    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016

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

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