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

March 10, 2019 updated by: Yu Danqing

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

1368

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guanzhou, Guangdong, China, 510000
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
          • huang jieleng, doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CIN
Time Frame: 72hours
Compared with before examination, the increase of serum creatinine conforms to the diagnostic criteria of contrast induced nephropathy.
72hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yu Danqing

Investigators

  • Principal Investigator: Danqing Yu, Doctor, Guangdong Cardiovascular Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2016

Primary Completion (Anticipated)

June 30, 2021

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

February 27, 2019

First Submitted That Met QC Criteria

March 10, 2019

First Posted (Actual)

March 13, 2019

Study Record Updates

Last Update Posted (Actual)

March 13, 2019

Last Update Submitted That Met QC Criteria

March 10, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 201704020124

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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