Clinical trial NCT02232997: Simplified Rapid Hydration in Preventing CA-AKI Among Patients With Chronic Kidney Disease
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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: Contrast-associated acute kidney injury
Coronary angiography
Chronic kidney disease
Intravenous hydration
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
Collaborators: name: Peking University First Hospital
name: Fudan University
name: The General Hospital of Northern Theater Command
name: Xiamen Cardiovascular Hospital, Xiamen University
name: First Affiliated Hospital of Guangxi Medical University
name: Sichuan Provincial People's Hospital
name: Wuhan Asia Heart Hospital
name: West China Hospital
name: Jining Medical University
name: The First Affiliated Hospital of Zhengzhou University
name: Fujian Provincial Hospital
name: First Affiliated Hospital, Sun Yat-Sen University
name: Fuling Central Hospital of Chongqing City
name: Second Xiangya Hospital of Central South University
name: People's Hospital of Guangxi Zhuang Autonomous Region
name: Maoming People's Hospital
name: Xijing Hospital
name: Beijing Friendship Hospital
name: Tangshan Gongren Hospital
name: Xuzhou Central Hospital
name: Southern Medical University, China
First posted: 2014-09-08
Enrollment: 1002
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Contrast-associated acute kidney injury a
timeFrame: 72 hours
Secondary outcomes:
measure: Number of Participants with Acute heart failure
timeFrame: post-procedural during hospitalization, an average of 3 days
measure: Contrast-associated acute kidney injury b
timeFrame: 72 hours
measure: Contrast-associated acute kidney injury c
timeFrame: 24 hours
measure: Contrast-associated acute kidney injury d
timeFrame: 48 hours
measure: Contrast-associated acute kidney injury e
timeFrame: 24 hours
measure: Major adverse clinical events
timeFrame: 1 year
measure: Change in eGFR a
timeFrame: 72 hours
measure: Change in eGFR b
timeFrame: 72 hours
measure: Contrast-induced persistence kidney injury
timeFrame: 3 months
measure: Length of stay
timeFrame: an average of 7 days
measure: Total hospitalization costs
timeFrame: an average of 7 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital
name: Jiyan Chen, MD
role: STUDY_CHAIR
affiliation: Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital
name: Yong Liu, MD
role: STUDY_DIRECTOR
affiliation: Peking University First Hospital
name: Yong Huo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Junbo Ge, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Southern Medical University
name: Pingyan Chen, MS
role: PRINCIPAL_INVESTIGATOR
References: