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Completed

NCT Number: NCT01560650

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

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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Nephrology Department,Guangdong General Hospital

Guangzhou, Guangdong, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CRRT

Device

Difference dose of CRRT

Primary outcomes

  1. death from any cause

    Time frame: 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 outcomes

  1. renal outcome of survivors

    Time frame: 14, 28 ,90 and 365 days after randomization

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

Sponsors and collaborators

Lead sponsor

Wei Shi

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Mar 22, 2012
Registry last updated
Jan 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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