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

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

Sponsors

Lead Sponsor: Guangdong Provincial People's Hospital

Collaborator: Peking University First Hospital
Fudan University

Source Guangdong Provincial People's Hospital
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.

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.

Overall Status Recruiting
Start Date April 2015
Completion Date October 2020
Primary Completion Date October 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Contrast-Induced Nephropathy 72 hours
Secondary Outcome
Measure Time Frame
Contrast Induced Acute Kidney Injury 24 hours
contrast-induced acute kidney injury 48 hours
Persistent renal damage 3 months
Major adverse cardiovascular events 1 year
Enrollment 1400
Condition
Intervention

Intervention Type: Other

Intervention Name: Long Hydration

Description: 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.

Arm Group Label: Long Hydration

Other Name: The control hydration group

Intervention Type: Other

Intervention Name: Short Hydration

Description: 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.

Arm Group Label: Short Hydration

Other Name: The simple hydration group

Eligibility

Criteria:

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).

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Overall Contact

Last Name: Chen Jiyan, MD

Phone: 86-20-83827812

Phone Ext.: 10528

Email: [email protected]

Location
Facility: Status: Contact: Guangdong General Hospital Yong Liu, MD 86-20-83827812 10528 [email protected]
Location Countries

China

Verification Date

April 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Guangdong Provincial People's Hospital

Investigator Full Name: Jiyan Chen

Investigator Title: MD

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Long Hydration

Type: Active Comparator

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

Label: Short Hydration

Type: Active Comparator

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

Acronym TIME
Study Design Info

Allocation: Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov