Clinical trial NCT01093131: Oral Versus Intravenous Hydration to Prevent Contrast Induced Nephropathy
Official title: Oral Hydration and Alkalinization is Non-Inferior to Intravenous Therapy for Prevention of Contrast Induced Nephropathy in Patients With Chronic Kidney Disease.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Contrast Induced Nephropathy
Keywords: Contrast induced nephropathy
Percutaneous transluminal coronary angioplasty
chronic kidney disease
Prevention
Equivalence
Lead sponsor: The Western Pennsylvania Hospital
Sponsor class: OTHER
Collaborators: name: West Penn Allegheny Health System
First posted: 2010-03-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The increased risk for contrast-induced nephropathy (CIN) in patients with chronic kidney disease (CKD) undergoing coronary angiography (CAG) has been established. Current and historical data on CIN prevention strategies have shown wide variation with respect to the optimal type, route and timing of these therapies. We investigate the role for oral hydration and/or oral sodium bicarbonate administration compared to intravenous hydration and/or sodium bicarbonate in patients with CKD undergoing CAG.

Detailed description: This is a single center study randomizing patients with CKD undergoing CAG into 4 groups: 1) Intravenous normal saline, 2) Intravenous normal saline and intravenous bicarbonate, 3) oral hydration, and 4) oral hydration and oral bicarbonate. The primary endpoint was the occurrence of contrast-medium-induced nephropathy defined as greater than 25% increase in serum creatinine from baseline or an absolute increase of 0.5 mg/dL from baseline at 72 hours following exposure to radiocontrast. Secondary endpoints include the length of hospitalization and in-house mortality.

Eligibility criteria: Inclusion Criteria:

1. Stable serum creatinine levels of at least 1.1 mg/dL or estimated creatinine clearance less than 60 mL/min
2. Scheduled for diagnostic, elective cardiac angiography

Exclusion Criteria:

1. Serum creatinine levels \>8.0 mg/dL
2. Change in serum creatinine levels of at least 0.5 mg/dL during the previous 24 hours
3. Preexisting dialysis
4. Multiple myeloma or other myeloproliferative disease
5. Current CHF or recent history of flash pulmonary edema
6. Current myocardial infarction
7. Symptomatic hypokalemia
8. Uncontrolled hypertension (treated systolic blood pressure \>200 mmHg or diastolic blood pressure \>100mmHg)
9. Exposure to radiocontrast within 7 days the study
10. Emergency Catheterization
11. Allergy to radiographic contrast
12. Pregnancy
13. Administration of dopamine, mannitol, fenoldapam, or N-acetylcysteine during the time of the study
14. Severe COPD
15. Serum Bicarb \> 28
16. Sodium \<133

Primary outcomes:
measure: Contrast Induced Nephropathy
timeFrame: 72 hours
Secondary outcomes:
measure: Length of Hospital Stay
timeFrame: 72 hours
measure: In-Hospital Mortality
timeFrame: 72 hours
measure: Aspiration
timeFrame: 72 hours
measure: Hypotension
timeFrame: 72 hours
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: The Western Pennsylvania Hospital
state: Pennsylvania
Study officials:
affiliation: The Western Pennsylvania Hospital
name: Roy Cho, MD MHSA
role: STUDY_DIRECTOR
References: