Chronic Kidney DiseaseTIMENCT02232997
Simplified Rapid Hydration in Preventing CA-AKI Among Patients With Chronic Kidney Disease
A study testing Standard Hydration and Simplified Hydration in people with Chronic Kidney Disease, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
No well-defined protocols exist to guide fluid administration for prevention of contrast-associated acute kidney injury in high risk patients. The investigators will compare long term hydration at routine speed(12h before and after procedure at 1ml/kg/h) with short term hydration at high speed(1h before and 4h after… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Standard Hydration and Simplified Hydration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,002 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age;
- Written informed consent;
- Candidates scheduled for coronary intervention (angiography and/or coronary intervention);
- Patients with chronic renal insufficiency, the baseline estimated glomerular filtration rate (eGFR) was 15-60 mL/min / 1.73 m²
- At least one risk factor (age>75 years, medical history of diabetes mellitus or hypertension, congestive heart failure [NYHA class >II or history of acute pulmonary edema]);
Who cannot join
- End-stage renal failure or heart/renal transplantation;
- History of exposure to contrast medium or acute infectious diseases within 48 hours prior to the procedure;
- Acute decompensated heart failure;
- Left ventricular thrombus;
- Allergy to contrast agent;
- Pregnancy or lactation;
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- Malignant tumour or life expectancy <1 year;
- Pre-procedural receipt of NSAIDs (except Asprin), aminoglycosides, cyclosporine or cisplatin in the past 48 h;
- Severe valve disease or elective undergoing surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Optimal Hydration With Sodium Chloride in High Risk Patients Undergoing Coronary Angiography, Reduction of Risk of Contrast-associated Acute Kidney Injury After Cardiac Catheterization 2 (TIME RESCIND 2) Study
No well-defined protocols exist to guide fluid administration for prevention of contrast-associated acute kidney injury in high risk patients. The investigators will compare long term hydration at routine speed(12h before and after procedure at 1ml/kg/h) with short term hydration at high speed(1h before and 4h after procedure at 3ml/kg/h) to verify our hypothesis that the short term hydration may not be inferior to the long one.
Read the detailed description
No well-defined protocols exist to guide fluid administration for prevention of contrast-associated acute kidney injury in high risk patients undergoing coronary angiography. Long term hydration at routine speed(12h before and after procedure at 1ml/kg/h), as the most recommended adequate hydration, has been carried out to prevent contrast-associated acute kidney injury in lots of clinical trials. Base on the data in the POSEIDON randomized controlled trial with hemodynamic-guided fluid administration, short term hydration at high speed(1h before and 4h after procedure at 3ml/kg/h) may not be inferior to the classic long term hydration, the speed should be reduced half of the intended speed in all the patients. We hypothesized short term hydration may not be inferior to the long one to reduced significantly the hospital stay and healthy cost.
- Conditions
- Chronic Kidney Disease
- Being tested
- Standard Hydration, Simplified Hydration
- Keywords
- Contrast-associated acute kidney injury, Coronary angiography, Chronic kidney disease, Intravenous hydration
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard HydrationOther
Also called The control hydration group
Sodium chloride hydration was set between 12 hours before coronary intervention (before contrast exposure during coronary angiography), continued during procedure, and 12 hours after procedure at 1 ml/kg/h (0.5 ml/kg/h For patients with congestive heart failure, New York Heart Association class>II, or LVEF < 35%). For patients weighing more than 80 kg, bolus and infusion rates are limited to calculated values for patients weighing 80 kg
Simplified HydrationOther
Also called The simple hydration group
Hydration with sodium chloride was set 1 hour before procedure (before contrast exposure during coronary angiography), continued during procedure, and 4 hours after procedure at 3ml/kg/h (1.5ml/kg/h For patients with congestive heart failure, New York Heart Association class>II, or LVEF <35%). For patients weighing more than 80 kg, bolus and infusion rates are limited to those calculated for patients weighing 80 kg.
| Study group | Role | What they receive |
|---|---|---|
| Standard Hydration | Active comparator | Standard long-term hydration, i.e. hydrated with normal saline 12 hours before and 12 hours after coronary intervention at a rate of 1 ml/kg/h Receives: Other: Standard Hydration |
| Simplified Hydration | Active comparator | Rapid short-term hydration, i.e. hydrated with normal saline from 1 hour before to 4 hours after coronary intervention at a rate of 3 ml/kg/h Receives: Other: Simplified Hydration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast-associated acute kidney injury a
Defined as ≥25% or 0.5 mg/dL absolute increase in serum creatinine from baseline during the first 48-72 hours after the procedure
Measured: 72 hours
Secondary outcomes (11)
Number of Participants with Acute heart failure
Defined as signs/symptoms of heart congestion and/or hypoperfusion by physical examination and auxiliary examination such as ECG, chest X-ray, laboratory assessment (biomarkers and echocardiography)
Measured: post-procedural during hospitalization, an average of 3 days
Contrast-associated acute kidney injury b
Defined as ≥0.5 mg/dL increase in serum creatinine from baseline during the first 48-72 hours after the procedure
Measured: 72 hours
Contrast-associated acute kidney injury c
Defined as ≥10% increase in serum cystatin c from baseline during the first 24 hours after the procedure
Measured: 24 hours
Contrast-associated acute kidney injury d
Defined as ≥50% or 0.3 mg/dL increase in serum creatinine from baseline during the first 48 hours after the procedure
Measured: 48 hours
Contrast-associated acute kidney injury e
Defined as ≥0.3mg/dl increase in serum cystatin c from baseline during the first 24 hours after the procedure
Measured: 24 hours
Major adverse clinical events
Including all-cause mortality, renal replacement therapy, nonfatal myocardial infarction, acute pulmonary edema, stroke, rehospitalization, bleeding
Measured: 1 year
Change in eGFR a
Change in eGFR within 48-72 hours after procedure (calculated according to the simplified MDRD formula)
Measured: 72 hours
Change in eGFR b
Change in eGFR within 48-72 hours after procedure (calculated according to the Cysc)
Measured: 72 hours
Contrast-induced persistence kidney injury
Defined as residual impairment of renal function indicated by a >25% reduction in creatinine clearance in comparison with the baseline value or dialysis requirement at 3 months
Measured: 3 months
Length of stay
Total length of hospital stay
Measured: an average of 7 days
Total hospitalization costs
Hospitalization expenses during hospitalization
Measured: an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2014 (estimated)
- Study startApr 2015
- Primary completionDec 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,002 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University First Hospital, Fudan University, The General Hospital of Northern Theater Command, Xiamen Cardiovascular Hospital, Xiamen University, First Affiliated Hospital of Guangxi Medical University, Sichuan Provincial People's Hospital, Wuhan Asia Heart Hospital, West China Hospital, Jining Medical University, The First Affiliated Hospital of Zhengzhou University, Fujian Provincial Hospital, First Affiliated Hospital, Sun Yat-Sen University, Fuling Central Hospital of Chongqing City, Second Xiangya Hospital of Central South University, People's Hospital of Guangxi Zhuang Autonomous Region, Maoming People's Hospital, Xijing Hospital, Beijing Friendship Hospital, Tangshan Gongren Hospital, Xuzhou Central Hospital, Southern Medical University, China
- Responsible party
- Principal investigator, Jiyan Chen, Guangdong Provincial People's Hospital
- Investigators
- Jiyan Chen, MD, Study chair, Guangdong Cardiovascular Institute, Guangdong Provincial People's HospitalYong Liu, MD, Study director, Guangdong Cardiovascular Institute, Guangdong Provincial People's HospitalYong Huo, MD, Principal investigator, Peking University First HospitalJunbo Ge, MD, Principal investigator, Fudan UniversityPingyan Chen, MS, Principal investigator, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02232997
- Sponsor's protocol ID
- CSC20140818
- Other IDs
- CSC20140818
- Acronym
- TIME
- Status last verified
- Sep 2022
- First submitted
- 1 Sep 2014
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimal Hydration With Sodium Chloride in High Risk Patients Undergoing Coronary Angiography, Reduction of Risk of Contrast-associated Acute Kidney Injury After Cardiac Catheterization 2 (TIME RESCIND 2) Study
- ClinicalTrials.gov ID
- NCT02232997
- Acronym / sponsor ID
- TIME / CSC20140818
- Conditions
- Chronic Kidney Disease
- Keywords
- Contrast-associated acute kidney injury, Coronary angiography, Chronic kidney disease, Intravenous hydration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,002 participants (actual)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Collaborators
- Peking University First Hospital, Fudan University, The General Hospital of Northern Theater Command, Xiamen Cardiovascular Hospital, Xiamen University, First Affiliated Hospital of Guangxi Medical University, Sichuan Provincial People's Hospital, Wuhan Asia Heart Hospital, West China Hospital, Jining Medical University, The First Affiliated Hospital of Zhengzhou University, Fujian Provincial Hospital, First Affiliated Hospital, Sun Yat-Sen University, Fuling Central Hospital of Chongqing City, Second Xiangya Hospital of Central South University, People's Hospital of Guangxi Zhuang Autonomous Region, Maoming People's Hospital, Xijing Hospital, Beijing Friendship Hospital, Tangshan Gongren Hospital, Xuzhou Central Hospital, Southern Medical University, China
- Study start
- Apr 2015 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 8 Sep 2014 (estimated)
- 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.
No well-defined protocols exist to guide fluid administration for prevention of contrast-associated acute kidney injury in high risk patients. The investigators will compare long term hydration at routine speed(12h before and after procedure at 1ml/kg/h) with short term hydration at high speed(1h before and 4h after procedure at 3ml/kg/h) to verify our hypothesis that the short term hydration may not be inferior to the long one.
Detailed description
No well-defined protocols exist to guide fluid administration for prevention of contrast-associated acute kidney injury in high risk patients undergoing coronary angiography. Long term hydration at routine speed(12h before and after procedure at 1ml/kg/h), as the most recommended adequate hydration, has been carried out to prevent contrast-associated acute kidney injury in lots of clinical trials. Base on the data in the POSEIDON randomized controlled trial with hemodynamic-guided fluid administration, short term hydration at high speed(1h before and 4h after procedure at 3ml/kg/h) may not be inferior to the classic long term hydration, the speed should be reduced half of the intended speed in all the patients. We hypothesized short term hydration may not be inferior to the long one to reduced significantly the hospital stay and healthy cost.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Hydration | Active comparator | Other: Standard HydrationStandard long-term hydration, i.e. hydrated with normal saline 12 hours before and 12 hours after coronary intervention at a rate of 1 ml/kg/h |
| Simplified Hydration | Active comparator | Other: Simplified HydrationRapid short-term hydration, i.e. hydrated with normal saline from 1 hour before to 4 hours after coronary intervention at a rate of 3 ml/kg/h |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 years of age;
- Written informed consent;
- Candidates scheduled for coronary intervention (angiography and/or coronary intervention);
- Patients with chronic renal insufficiency, the baseline estimated glomerular filtration rate (eGFR) was 15-60 mL/min / 1.73 m²
- At least one risk factor (age>75 years, medical history of diabetes mellitus or hypertension, congestive heart failure [NYHA class >II or history of acute pulmonary edema]);
Key exclusion criteria (9 listed)
- End-stage renal failure or heart/renal transplantation;
- History of exposure to contrast medium or acute infectious diseases within 48 hours prior to the procedure;
- Acute decompensated heart failure;
- Left ventricular thrombus;
- Allergy to 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 |
|---|---|---|
| Standard HydrationAlso: The control hydration groupSodium chloride hydration was set between 12 hours before coronary intervention (before contrast exposure during coronary angiography), continued during procedure, and 12 hours after procedure at 1 ml/kg/h (0.5 ml/kg/h For patients with congestive heart failure, New York Heart Association class>II, or LVEF < 35%). For patients weighing more than 80 kg, bolus and infusion rates are limited to calculated values for patients weighing 80 kg | Other | Standard Hydration |
| Simplified HydrationAlso: The simple hydration groupHydration with sodium chloride was set 1 hour before procedure (before contrast exposure during coronary angiography), continued during procedure, and 4 hours after procedure at 3ml/kg/h (1.5ml/kg/h For patients with congestive heart failure, New York Heart Association class>II, or LVEF <35%). For patients weighing more than 80 kg, bolus and infusion rates are limited to those calculated for patients weighing 80 kg. | Other | Simplified Hydration |
Primary outcome
Contrast-associated acute kidney injury a
Time frame: 72 hours
Defined as ≥25% or 0.5 mg/dL absolute increase in serum creatinine from baseline during the first 48-72 hours after the procedure
11 secondary outcomes
Number of Participants with Acute heart failure
Time frame: post-procedural during hospitalization, an average of 3 days
Contrast-associated acute kidney injury b
Time frame: 72 hours
Contrast-associated acute kidney injury c
Time frame: 24 hours
Contrast-associated acute kidney injury d
Time frame: 48 hours
Contrast-associated acute kidney injury e
Time frame: 24 hours
Major adverse clinical events
Time frame: 1 year
Change in eGFR a
Time frame: 72 hours
Change in eGFR b
Time frame: 72 hours
Contrast-induced persistence kidney injury
Time frame: 3 months
Length of stay
Time frame: an average of 7 days
Total hospitalization costs
Time frame: an average of 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
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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.
Jiyan Chen, MD study chair
Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital
Yong Liu, MD study director
Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital
Yong Huo, MD principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Hydration and Simplified Hydration in people with Chronic Kidney Disease, run by Guangdong Provincial People's Hospital 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 3 Oct 2022. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contrast-associated acute kidney injury a (time frame: 72 hours). 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 3 Oct 2022.