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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01560650

Enrollment

211

Registered

2012-03-22

Start date

2011-03-31

Completion date

2015-08-31

Last updated

2016-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

Keywords

CRRT, cardiac surgery associated acute kidney injury, Intensity

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.

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.

Interventions

DEVICECRRT

Difference dose of CRRT

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026