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

NCT ID: NCT01560650

Last Updated: 2016-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

211 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

CRRT

Intervention Type DEVICE

Difference dose of CRRT

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.

Group Type EXPERIMENTAL

CRRT

Intervention Type DEVICE

Difference dose of CRRT

Interventions

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CRRT

Difference dose of CRRT

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wei Shi

OTHER

Sponsor Role lead

Responsible Party

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Wei Shi

Director of renal division of Guangdong General Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Wei Shi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Guangdong Provincial People's Hospital

Locations

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Nephrology Department,Guangdong General Hospital

Guangzhou, Guangdong, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 36416787 (View on PubMed)

Other Identifiers

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LXL-CRRT2535

Identifier Type: -

Identifier Source: org_study_id

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