To Compare Intravenous and Oral Hydration of the Prevention for CIN in Elderly Patients Undergoing Intravenous CECT
CINOECT
1 other identifier
interventional
1,368
1 country
1
Brief Summary
To Compare Intravenous and Oral Hydration of the Prevention for Contrast-induced Nephropathy in Elderly Patients Undergoing Intravenous Contrast-enhanced Computed Tomography.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 8, 2016
CompletedFirst Submitted
Initial submission to the registry
February 27, 2019
CompletedFirst Posted
Study publicly available on registry
March 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2021
CompletedMarch 13, 2019
March 1, 2019
4.7 years
February 27, 2019
March 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CIN
Compared with before examination, the increase of serum creatinine conforms to the diagnostic criteria of contrast induced nephropathy.
72hours
Study Arms (2)
distilled water
EXPERIMENTALOral 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
Saline
PLACEBO COMPARATORintravenous saline hydration at the rate of 1 mL/kg/h rate during undergoing enhanced computed tomography examination before and after 12 hours
Interventions
Eligibility Criteria
You may qualify if:
- Age\>21
- informed consent
- Undergoing Intravenous Contrast-enhanced Computed Tomography
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yu Danqinglead
Study Sites (1)
Guangdong provincial people's hospital
Guanzhou, Guangdong, 510000, China
Study Officials
- PRINCIPAL INVESTIGATOR
Danqing Yu, Doctor
Guangdong Cardiovascular Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director,Clinical Professor
Study Record Dates
First Submitted
February 27, 2019
First Posted
March 13, 2019
Study Start
October 8, 2016
Primary Completion
June 30, 2021
Study Completion
October 1, 2021
Last Updated
March 13, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share