Clinical trial NCT01218828: Prevention of Contrast Renal Injury With Different Hydration Strategies
Official title: Hydration With Different Sodium Chloride Protocols for the Prevention of Contrast Medium-induced Nephropathy in Patients Undergoing Coronary Angiography: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contrast Medium-induced Nephropathy
Keywords: Contrast
nephropathy
cardiac catheterization
angiography
percutaneous coronary intervention is
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2010-10-11
Enrollment: 396
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: 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:

1. 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.
2. 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.

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

Primary outcomes:
measure: Contrast induced nephropathy
timeFrame: Within four days of contrast exposure
Secondary outcomes:
measure: Renal replacement therapy, myocardial infarction, all-cause mortality
timeFrame: 30 days and long-term
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kaiser Permanente
state: California
Study officials:
affiliation: Kaiser Permanente
name: Somjot S Brar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brar SS, Aharonian V, Mansukhani P, Moore N, Shen AY, Jorgensen M, Dua A, Short L, Kane K. Haemodynamic-guided fluid administration for the prevention of contrast-induced acute kidney injury: the POSEIDON randomised controlled trial. Lancet. 2014 May 24;383(9931):1814-23. doi: 10.1016/S0140-6736(14)60689-9.