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Plasma Cystatin C and Acute Kidney Injury

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Jinhua Central Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Hongying Ni, Jinhua Central Hospital
ClinicalTrials.gov Identifier:
NCT01652755
First received: July 26, 2012
Last updated: August 3, 2012
Last verified: August 2012
  Purpose

To evaluate the utility of plasma cystatin C(pCysC) as a predictive and diagnostic marker of acute kidney injury(AKI) in patients undergone cardiopulmonary bypass surgery.


Condition
Acute Kidney Injury

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Use of Cystatin C in Predicting AKI in Patients Undergone Cardiopulmonary Bypass Surgery

Further study details as provided by Jinhua Central Hospital:

Estimated Enrollment: 100
Study Start Date: April 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
AKI group
patients with AKI after cardiopulmonary bypass surgery
non-AKI group
patients without AKI during study period

Detailed Description:

This is a prospective AKI observational study in patients undergone cardiopulmonary bypass surgery. pCysC and plasma creatine will be measured at entry to ICU.AKI was defined as 50% increase in plasma creatine above baseline.The predictive and diagnostic performance of pCysC will be assessed from area under receiver operator characteristic curve(AUC) and odds ratio(OR).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients undergone cardiopulmonary bypass surgery

Criteria

Inclusion Criteria:

  • patients with CPB and admitted to ICU

Exclusion Criteria:

  • patients with the age >80 or <18 years
  • with preexisting renal dysfunction
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01652755

Contacts
Contact: Hongying Ni, MM 86 ext 57982552629 nihongying2@163.com

Locations
China, Zhejiang
Jinhua central hospital Recruiting
Jinhua, Zhejiang, China, 321000
Contact: Hongying Ni, MM    86 ext 57982552629    nihongying2@163.com   
Principal Investigator: Hongying Ni, MM         
Sponsors and Collaborators
Jinhua Central Hospital
Investigators
Study Chair: Hongying Ni, MM Jinhua municipal central hospital
  More Information

No publications provided

Responsible Party: Hongying Ni, Department vice director, Jinhua Central Hospital
ClinicalTrials.gov Identifier: NCT01652755     History of Changes
Other Study ID Numbers: N-H-Y
Study First Received: July 26, 2012
Last Updated: August 3, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Jinhua Central Hospital:
cystatin C,acute kidney injury,

Additional relevant MeSH terms:
Acute Kidney Injury
Kidney Diseases
Renal Insufficiency
Urologic Diseases
Cystatins
Cysteine Proteinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on November 23, 2014