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

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01560650
• Other study ID #: LXL-CRRT2535
• Status: Completed
• Phase: Phase 4
• First received: March 20, 2012
• Last updated: January 17, 2016
• Start date: March 2011
• Est. completion date: August 2015

Study information

• Verified date: January 2016
• Source: Guangdong General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Device:
• CRRT
Difference dose of CRRT

Locations

Country	Name	City	State
China	Nephrology Department,Guangdong General Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Wei Shi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	renal outcome of survivors	Secondary outcomes were renal outcome of survivors14, 28 ,90 and 365 days after randomization	14, 28 ,90 and 365 days after randomization	Yes