Prevention of Contrast Renal Injury With Different Hydration Strategies

Study Overview
=================
Brief Summary
-----------------
Using a randomized controlled trial design, two hydration protocols for the prevention of contrast medium-induced nephropathy will be tested.

Detailed Description
-----------------
The study population will be recruited from subjects undergoing cardiac catheterization. Subjects will be randomized to one of two hydration protocols: normal saline at 3 mL/kg for one hour prior to contrast exposure and 1.5 mL/kg/hr during and for four hours post procedure. normal saline at 3 mL/kg for one hour prior to contrast exposure and then the fluid rate would be adjusted according to the left ventricular end diastolic pressure (LVEDP). The fluid rate based upon the LVEDP measurement is maintained during the procedure and for four hours post procedure. The LVEDP hydration strategy follows: (2A) < 13 mmHg, 5 mL/kg/hr during and for four hours post procedure. (2B) 13-18 mmHg, 3 mL/kg during and for four hours post procedure. (2C) > 18 mmHg, 1.5 mL/kg during and four hours post procedure. Renal function assessment will be made using standard laboratory measures post procedure.

Official Title
-----------------
Hydration With Different Sodium Chloride Protocols for the Prevention of Contrast Medium-induced Nephropathy in Patients Undergoing Coronary Angiography: a Randomized Trial

Conditions
-----------------
Contrast Medium-induced Nephropathy

Intervention / Treatment
-----------------
* Other: LVEDP -Based hydration strategy
* Other: Standard hydration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: estimated GFR less than or equal to 60 mL/min/1.73 m^2 age greater than 18 years at least one of the following: diabetes mellitus, history of congestive heart failure, hypertension, or age greater than 75 years. Exclusion Criteria: patients unable to give consent undergoing emergency cardiac catheterization on renal replacement therapy exposure to contrast media within the prior two days pulmonary edema or active congestive heart failure kidney transplant status severe valvular abnormalities change in serum creatinine greater than 15% over the prior two days

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard therapy<br>Hydration with 0.9% saline per a standard protocol (control group) | Other: Standard hydration<br> <br> |
| Experimental: LVEDP-based hydration strategy<br>LVEDP guided hydration with 0.9% saline (treatment group) | Other: LVEDP -Based hydration strategy<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contrast induced nephropathy |  | Within four days of contrast exposure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal replacement therapy, myocardial infarction, all-cause mortality |  | 30 days and long-term | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contrast, nephropathy, cardiac catheterization, angiography, percutaneous coronary intervention is