Back to resultsSimplified Rapid Hydration in Preventing CA-AKI Among Patients With Chronic Kidney Disease (TIME)
Primary Purpose
Chronic Kidney Disease
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Standard Hydration
Simplified Hydration
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Kidney Disease focused on measuring Contrast-associated acute kidney injury, Coronary angiography, Chronic kidney disease, Intravenous hydration
Eligibility Criteria
Inclusion Criteria:
- ≥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]);
Exclusion Criteria:
- 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;
- 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.
Sites / Locations
- Guangdong Provincial People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Standard Hydration
Simplified Hydration
Arm Description
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
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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)
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
Contrast-associated acute kidney injury c
Defined as ≥10% increase in serum cystatin c from baseline during the first 24 hours after the procedure
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
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
Major adverse clinical events
Including all-cause mortality, renal replacement therapy, nonfatal myocardial infarction, acute pulmonary edema, stroke, rehospitalization, bleeding
Change in eGFR a
Change in eGFR within 48-72 hours after procedure (calculated according to the simplified MDRD formula)
Change in eGFR b
Change in eGFR within 48-72 hours after procedure (calculated according to the Cysc)
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
Length of stay
Total length of hospital stay
Total hospitalization costs
Hospitalization expenses during hospitalization
Full Information
NCT ID
NCT02232997
First Posted
September 1, 2014
Last Updated
September 29, 2022
Sponsor
Guangdong Provincial People's Hospital
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, Maoming People's Hospital, Xijing Hospital, Beijing Friendship Hospital, Tangshan Gongren Hospital, Xuzhou Central Hospital, Southern Medical University, China
1. Study Identification
Unique Protocol Identification Number
NCT02232997
Brief Title
Simplified Rapid Hydration in Preventing CA-AKI Among Patients With Chronic Kidney Disease
Acronym
TIME
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
December 2021 (Actual)
Study Completion Date
December 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Provincial People's Hospital
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, Maoming People's Hospital, Xijing Hospital, Beijing Friendship Hospital, Tangshan Gongren Hospital, Xuzhou Central Hospital, Southern Medical University, China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Contrast-associated acute kidney injury, Coronary angiography, Chronic kidney disease, Intravenous hydration
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1002 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Hydration
Arm Type
Active Comparator
Arm Description
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
Arm Title
Simplified Hydration
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Standard Hydration
Other Intervention Name(s)
The control hydration group
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Simplified Hydration
Other Intervention Name(s)
The simple hydration group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Contrast-associated acute kidney injury a
Description
Defined as ≥25% or 0.5 mg/dL absolute increase in serum creatinine from baseline during the first 48-72 hours after the procedure
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Number of Participants with Acute heart failure
Description
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)
Time Frame
post-procedural during hospitalization, an average of 3 days
Title
Contrast-associated acute kidney injury b
Description
Defined as ≥0.5 mg/dL increase in serum creatinine from baseline during the first 48-72 hours after the procedure
Time Frame
72 hours
Title
Contrast-associated acute kidney injury c
Description
Defined as ≥10% increase in serum cystatin c from baseline during the first 24 hours after the procedure
Time Frame
24 hours
Title
Contrast-associated acute kidney injury d
Description
Defined as ≥50% or 0.3 mg/dL increase in serum creatinine from baseline during the first 48 hours after the procedure
Time Frame
48 hours
Title
Contrast-associated acute kidney injury e
Description
Defined as ≥0.3mg/dl increase in serum cystatin c from baseline during the first 24 hours after the procedure
Time Frame
24 hours
Title
Major adverse clinical events
Description
Including all-cause mortality, renal replacement therapy, nonfatal myocardial infarction, acute pulmonary edema, stroke, rehospitalization, bleeding
Time Frame
1 year
Title
Change in eGFR a
Description
Change in eGFR within 48-72 hours after procedure (calculated according to the simplified MDRD formula)
Time Frame
72 hours
Title
Change in eGFR b
Description
Change in eGFR within 48-72 hours after procedure (calculated according to the Cysc)
Time Frame
72 hours
Title
Contrast-induced persistence kidney injury
Description
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
Time Frame
3 months
Title
Length of stay
Description
Total length of hospital stay
Time Frame
an average of 7 days
Title
Total hospitalization costs
Description
Hospitalization expenses during hospitalization
Time Frame
an average of 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥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]);
Exclusion Criteria:
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;
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiyan Chen, MD
Organizational Affiliation
Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yong Liu, MD
Organizational Affiliation
Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yong Huo, MD
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Junbo Ge, MD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pingyan Chen, MS
Organizational Affiliation
Southern Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
501080
Country
China
12. IPD Sharing Statement
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Simplified Rapid Hydration in Preventing CA-AKI Among Patients With Chronic Kidney Disease
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