TIME: The optImal Hydration With sodiuM chloridE in High Risk Patients Undergoing Coronary Angiography

Sponsor

Guangdong Provincial People's Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02232997

Collaborator

Peking University First Hospital (Other), Fudan University (Other)

1,400

Enrollment

Location

Arms

Duration (Months)

21.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

No well-defined protocols exist to guide fluid administration for prevention of contrast induced nephropathy 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease	Other: Long Hydration Other: Short Hydration	N/A

Detailed Description

No well-defined protocols exist to guide fluid administration for prevention of contrast induced nephropathy 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 induced nephropathy in lots of clinical trials. Base on the data in the POSEIDON randomised controlled trial with haemodynamic-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

Study Type:

Interventional

Anticipated Enrollment :

1400 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

The optImal Hydration With sodiuM chloridE in High Risk Patients Undergoing Coronary Angiography, REduction of riSk of Contrast-Induced Nephropathy After carDiac Catheterization 2 (TIME RESCIND 2) Study

Study Start Date :

Apr 1, 2015

Anticipated Primary Completion Date :

Oct 1, 2019

Anticipated Study Completion Date :

Oct 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Long Hydration Long term hydration at routine speed(12h before and after procedure)	Other: Long Hydration The hydration with sodium chloride was set 12 hours before the procedure (before contrast exposure during coronary angiography), continued for the duration of the procedure, and for 12 hours post-procedure at the speed of 1ml/kg/hr (0.5ml/kg/hr for patients with congestive heart failure, New York Heart Association class III or LVEF<35%). For patients who weighed more than 80 kg, the bolus and infusion rate were limited to those calculated for patients weighing 80 kg. Other Names: The control hydration group
Active Comparator: Short Hydration Short term hydration at high speed(1h before and 4h after procedure)	Other: Short Hydration The hydration with sodium chloride was set 1 hour before the procedure (before contrast exposure during coronary angiography), continued for the duration of the procedure, and for 4 hours post-procedure at the speed of 3ml/kg/hr (1.5ml/kg/hr for patients with congestive heart failure, New York Heart Association class III or LVEF<35%). For patients who weighed more than 80 kg, the bolus and infusion rate were limited to those calculated for patients weighing 80 kg. Other Names: The simple hydration group

Arm

Intervention/Treatment

Active Comparator: Long Hydration

Long term hydration at routine speed(12h before and after procedure)

Other: Long Hydration

The hydration with sodium chloride was set 12 hours before the procedure (before contrast exposure during coronary angiography), continued for the duration of the procedure, and for 12 hours post-procedure at the speed of 1ml/kg/hr (0.5ml/kg/hr for patients with congestive heart failure, New York Heart Association class III or LVEF<35%). For patients who weighed more than 80 kg, the bolus and infusion rate were limited to those calculated for patients weighing 80 kg.

Other Names:

The control hydration group

Active Comparator: Short Hydration

Short term hydration at high speed(1h before and 4h after procedure)

Other: Short Hydration

The hydration with sodium chloride was set 1 hour before the procedure (before contrast exposure during coronary angiography), continued for the duration of the procedure, and for 4 hours post-procedure at the speed of 3ml/kg/hr (1.5ml/kg/hr for patients with congestive heart failure, New York Heart Association class III or LVEF<35%). For patients who weighed more than 80 kg, the bolus and infusion rate were limited to those calculated for patients weighing 80 kg.

Other Names:

The simple hydration group

Outcome Measures

Primary Outcome Measures

Contrast-Induced Nephropathy [72 hours]
defined as a greater than 25% or an absolute increase of 0.5 mg/dl in serum creatinine over baseline during the first 48- 72 h post-procedure

Secondary Outcome Measures

Contrast Induced Acute Kidney Injury [24 hours]
defined as a greater than 10% or an absolute increase of 0.3mg/dl in serum Cystatin C over baseline during the first 24 h post-procedure.
contrast-induced acute kidney injury [48 hours]
defined as a greater than 50% or an absolute increase of 0.3 mg/dl in serum creatinine over baseline during the first 48h post-procedure
Persistent renal damage [3 months]
Defined as a residual impairment of renal function indicated by a reduction of creatinine clearance more than 25% at 3 months in comparison with baseline
Major adverse cardiovascular events [1 year]
acute pulmonary edema, cardiogenic shock, CIN requiring renal replacement therapy (hemofiltration or hemodiafiltration), clinically significant arrhythmias, and death.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patients undergoing coronary angiography;
an estimated glomerular filtration rate (eGFR) of 60 mL/min per 1·73 m2 or lower;
age 18 years or older;
at least one of the following: diabetes mellitus, history of congestive heart failure, hypertension (blood pressure >140/90 mm Hg or treatment with anti- hypertensive medication), or age older than 75 years.

Exclusion Criteria:

inability to obtain consent from participants;
emergency cardiac catheterisation (eg, primary percutaneous coronary intervention for ST-segment elevation myocardial infarction);
renal replacement therapy;
exposure to radiographic contrast media within the previous 2 days and in the future 3 days;
allergy to radiographic contrast media;
acute decompensated heart failure;
severe valvular heart disease;
left ventricular thrombus;
history of kidney or heart transplantation;
change in estimated GFR of 7.5% or more per day or a cumulative change of 15% or more during the preceding 2 or more days(two blood samples collected within 3 months).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guangdong General Hospital	Guangzhou	Guangdong	China	501080

Sponsors and Collaborators

Guangdong Provincial People's Hospital
Peking University First Hospital
Fudan University

Investigators

Study Chair: Jiyan Chen, MD, Guangdong Cardiovascular Institute,Guangdong General Hospital
Study Director: Yong Liu, MD, Guangdong Cardiovascular Institute,Guangdong General Hospital
Principal Investigator: Yong Huo, MD, Peking University First Hospital
Principal Investigator: Junbo Ge, MD, Fudan University
Principal Investigator: Pingyan Chen, MS, Southern Medical University