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To Compare Intravenous and Oral Hydration of the Prevention for CIN in Elderly Patients Undergoing Intravenous CECT (CINOECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03872739
Recruitment Status : Unknown
Verified March 2019 by Yu Danqing, Guangdong Academy of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : March 13, 2019
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Yu Danqing, Guangdong Academy of Medical Sciences

Study Description
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Brief Summary:
To Compare Intravenous and Oral Hydration of the Prevention for Contrast-induced Nephropathy in Elderly Patients Undergoing Intravenous Contrast-enhanced Computed Tomography.

Condition or disease Intervention/treatment Phase
CIN Procedure: enhanced computed tomography Not Applicable

Detailed Description:
The prospective multicenter randomized controlled clinical research discusses the comparison of oral and intravenous hydration for prevention of contrast-induced nephropathy in elderly patients with enhanced computed tomography, establishing a simple hydration proposal.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1368 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: To Compare Intravenous and Oral Hydration of the Prevention for Contrast-induced Nephropathy in Elderly Patients Undergoing Intravenous Contrast-enhanced Computed Tomography： A Multi-center Randomized Control Trail
Actual Study Start Date : October 8, 2016
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans

Arms and Interventions
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Arm Intervention/treatment
Experimental: distilled water
Oral distilled water at the rate of 3 mL/kg/h rate during undergoing enhanced computed tomography examination before 1-2 and after 4-6 hours
 Procedure: enhanced computed tomography
undergoing enhanced computed tomography
Placebo Comparator: Saline
intravenous saline hydration at the rate of 1 mL/kg/h rate during undergoing enhanced computed tomography examination before and after 12 hours
 Procedure: enhanced computed tomography
undergoing enhanced computed tomography


Outcome Measures
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Primary Outcome Measures :
  1. CIN [ Time Frame: 72hours ]
    Compared with before examination, the increase of serum creatinine conforms to the diagnostic criteria of contrast induced nephropathy.


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age>21
  • informed consent
  • Undergoing Intravenous Contrast-enhanced Computed Tomography

Exclusion Criteria:

  • CT enhancement was not performed;
  • Dialysis treatment of patients with end-stage renal failure or heart, kidney transplantation;
  • Exposure to radioactive contrast medium within 48 hours prior to or within 72 hours of examination;
  • Acute decompensated heart failure;
  • Allergic to radioactive contrast agent;
  • Be subjected to life - threatening trauma;
  • Severe infection;
  • Surgery was performed within 2 days of CT examination.
  • Combined with multiple myeloma, urinary obstruction, aortic dissection
  • Can cause acute kidney injury disease;
  • Use of aminoglycosides and other nephrotoxic drugs 2 weeks before.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03872739


Contacts
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Contact: Danqing Yu, Doctor 13631349257 gdydq100@126.com

Locations
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China, Guangdong
Guangdong provincial people's hospital Recruiting
Guanzhou, Guangdong, China, 510000
Contact: huang jieleng, doctor         
Sponsors and Collaborators
Yu Danqing
Investigators
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Principal Investigator: Danqing Yu, Doctor Guangdong Cardiovascular Institute
More Information
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Responsible Party: Yu Danqing, Director,Clinical Professor, Guangdong Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT03872739    
Other Study ID Numbers: 201704020124
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Yu Danqing, Guangdong Academy of Medical Sciences:
CIN
Hydration
enhanced computed tomography