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

January 17, 2016 updated by: Wei Shi

Effect of the Intensity of Continuous Renal Replacement Therapy in Patients With Cardiac Surgery Associated Acute Kidney Injury (CRITERIA STUDY)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

211

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Nephrology Department,Guangdong General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
14, 28 ,90 and 365 days after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
14, 28 ,90 and 365 days after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wei Shi

Investigators

  • Principal Investigator: Wei Shi, MD, PhD, Guangdong Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

March 20, 2012

First Submitted That Met QC Criteria

March 21, 2012

First Posted (Estimate)

March 22, 2012

Study Record Updates

Last Update Posted (Estimate)

January 20, 2016

Last Update Submitted That Met QC Criteria

January 17, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LXL-CRRT2535

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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