NCT01560650

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
211

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2012

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

January 20, 2016

Status Verified

January 1, 2016

Enrollment Period

4.4 years

First QC Date

March 20, 2012

Last Update Submit

January 17, 2016

Conditions

Keywords

CRRTcardiac surgery associated acute kidney injuryIntensity

Outcome Measures

Primary Outcomes (1)

  • death from any cause

    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 Outcomes (1)

  • renal outcome of survivors

    14, 28 ,90 and 365 days after randomization

Study Arms (2)

high dose (35ml/kg/h)

EXPERIMENTAL

\> = 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

low dose (25ml/kg/h)

EXPERIMENTAL

\> = 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

Interventions

CRRTDEVICE

Difference dose of CRRT

high dose (35ml/kg/h)low dose (25ml/kg/h)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \< 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nephrology Department,Guangdong General Hospital

Guangzhou, Guangdong, China

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.

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Wei Shi, MD, PhD

    Guangdong Provincial People's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of renal division of Guangdong General Hospital

Study Record Dates

First Submitted

March 20, 2012

First Posted

March 22, 2012

Study Start

March 1, 2011

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

January 20, 2016

Record last verified: 2016-01

Locations