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

• Sponsor: Wei Shi (Other)
• Overall Status: Completed
• CT.gov ID: NCT01560650
• Collaborator: (none)
• Enrollment: 211
• Location: 1
• Arms: 2
• Duration (Months): 53
• Patients Per Site Per Month: 4

Study Details

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
• 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: Mar 1, 2011
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 2015

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 [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 [14, 28 ,90 and 365 days after randomization]

   Secondary outcomes were renal outcome of survivors14, 28 ,90 and 365 days after randomization

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Nephrology Department,Guangdong General Hospital	Guangzhou	Guangdong	China

Sponsors and Collaborators

• Wei Shi

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wei Shi, Director of renal division of Guangdong General Hospital, Guangdong Provincial People's Hospital
• ClinicalTrials.gov Identifier: NCT01560650
• Other Study ID Numbers: LXL-CRRT2535
• First Posted: Mar 22, 2012
• Last Update Posted: Jan 20, 2016
• Last Verified: Jan 1, 2016

• Keywords provided by Wei Shi, Director of renal division of Guangdong General Hospital, Guangdong Provincial People's Hospital: CRRT; cardiac surgery associated acute kidney injury; Intensity
• Additional relevant MeSH terms: Acute Kidney Injury; Wounds and Injuries

Study Results

No Results Posted as of Jan 20, 2016