CINCINOECTNCT03872739
To Compare Intravenous and Oral Hydration of the Prevention for CIN in Elderly Patients Undergoing Intravenous CECT
A study testing enhanced computed tomography in people with CIN, run by Yu Danqing at 1 site in China.
Trial summary
To Compare Intravenous and Oral Hydration of the Prevention for Contrast-induced Nephropathy in Elderly Patients Undergoing Intravenous Contrast-enhanced Computed Tomography. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- CIN
- What is being tested?
- enhanced computed tomography
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,368 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2016to Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age>21
- informed consent
- Undergoing Intravenous Contrast-enhanced Computed Tomography
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong provincial people's hospital
Guanzhou, Guangdong, 510000
huang jieleng, doctor
About this study
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
To Compare Intravenous and Oral Hydration of the Prevention for Contrast-induced Nephropathy in Elderly Patients Undergoing Intravenous Contrast-enhanced Computed Tomography.
Read the 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.
- Conditions
- CIN
- Being tested
- enhanced computed tomography
- Keywords
- CIN, Hydration, enhanced computed tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enhanced computed tomographyProcedure or surgery
undergoing enhanced computed tomography
| Study group | Role | What they receive |
|---|---|---|
| distilled water | Experimental | 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 Receives: Procedure: enhanced computed tomography |
| Saline | Placebo comparator | intravenous saline hydration at the rate of 1 mL/kg/h rate during undergoing enhanced computed tomography examination before and after 12 hours Receives: Procedure: enhanced computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
CIN
Compared with before examination, the increase of serum creatinine conforms to the diagnostic criteria of contrast induced nephropathy.
Measured: 72hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start8 Oct 2016
- Primary completion30 Jun 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CINStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,368 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yu Danqing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yu Danqing, Guangdong Academy of Medical Sciences
- Investigators
- Danqing Yu, Doctor, Principal investigator, Guangdong Cardiovascular Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872739
- Sponsor's protocol ID
- 201704020124
- Acronym
- CINOECT
- Status last verified
- Mar 2019
- First submitted
- 27 Feb 2019
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03872739
- Acronym / sponsor ID
- CINOECT / 201704020124
- Conditions
- CIN
- Keywords
- CIN, Hydration, enhanced computed tomography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,368 participants (estimated)
- Lead sponsor
- Yu DanqingUniversity, hospital or other
- Study start
- 8 Oct 2016 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 13 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To Compare Intravenous and Oral Hydration of the Prevention for Contrast-induced Nephropathy in Elderly Patients Undergoing Intravenous Contrast-enhanced Computed Tomography.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| distilled water | Experimental | Procedure: enhanced computed tomographyOral 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 comparator | Procedure: enhanced computed tomographyintravenous saline hydration at the rate of 1 mL/kg/h rate during undergoing enhanced computed tomography examination before and after 12 hours |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age>21
- informed consent
- Undergoing Intravenous Contrast-enhanced Computed Tomography
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enhanced computed tomographyundergoing enhanced computed tomography | Procedure or surgery | Saline, distilled water |
Primary outcome
CIN
Time frame: 72hours
Compared with before examination, the increase of serum creatinine conforms to the diagnostic criteria of contrast induced nephropathy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danqing Yu, Doctor principal investigator
Guangdong Cardiovascular Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enhanced computed tomography in people with CIN, run by Yu Danqing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Danqing Yu, Doctor (13631349257, gdydq100@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CIN (time frame: 72hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.