Study Stopped
Investigator left institution
Oral Versus Intravenous Hydration to Prevent Contrast Induced Nephropathy
HYDRATE
Oral Hydration and Alkalinization is Non-Inferior to Intravenous Therapy for Prevention of Contrast Induced Nephropathy in Patients With Chronic Kidney Disease.
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2005
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 25, 2010
CompletedFirst Posted
Study publicly available on registry
March 25, 2010
CompletedOctober 4, 2019
November 1, 2016
4.6 years
February 25, 2010
October 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Contrast 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.
72 hours
Secondary Outcomes (4)
Length of Hospital Stay
72 hours
In-Hospital Mortality
72 hours
Aspiration
72 hours
Hypotension
72 hours
Study Arms (4)
Intravenous Hydration
ACTIVE COMPARATORPretreatment with a 3 mL/kg bolus of intravenous normal saline solution (154 mEq/L) over 1 hour, immediately prior to contrast exposure followed by intravenous infusion of 1ml/kg per for 6 hours after the procedure.
Intravenous hydration and sodium bicarbonate
ACTIVE COMPARATORPretreatment with a 3 mL/kg bolus of intravenous sodium bicarbonate solution (154 mEq/L) over 1 hour, immediately prior to contrast exposure followed by intravenous infusion of 1 mL/kg for 6 hours after the procedure.
Oral hydration
ACTIVE COMPARATOROral hydration with 500 mL of water to be started 4 hours prior to contrast exposure and stopped 2 hours prior to procedure followed by oral hydration with 600 mL of water post procedure
Oral hydration and oral sodium bicarbonate
ACTIVE COMPARATOROral hydration with 500 mL of water to be started 4 hours prior to procedure and stopped 2 hours prior to contrast exposure, with the addition of 3.9 grams (46.4 mEq) of oral sodium bicarbonate to be given 20 minutes prior to contrast exposure followed by 1.95 grams (30.4 mEq) of oral sodium bicarbonate 2 hours and 4 hours after the initial dose
Interventions
Oral hydration with 500 mL of water to be started 4 hours prior to contrast exposure and stopped 2 hours prior to procedure followed by oral hydration with 600 mL of water post procedure
Oral hydration with 500 mL of water to be started 4 hours prior to procedure and stopped 2 hours prior to contrast exposure, with the addition of 3.9 grams (46.4 mEq) of oral sodium bicarbonate to be given 20 minutes prior to contrast exposure followed by 1.95 grams (30.4 mEq) of oral sodium bicarbonate 2 hours and 4 hours after the initial dose
Pretreatment with a 3 mL/kg bolus of intravenous normal saline solution (154 mEq/L) over 1 hour, immediately prior to contrast exposure followed by intravenous infusion of 1ml/kg per for 6 hours after the procedure.
Pretreatment with a 3 mL/kg bolus of intravenous sodium bicarbonate solution (154 mEq/L) over 1 hour, immediately prior to contrast exposure followed by intravenous infusion of 1 mL/kg for 6 hours after the procedure.
Eligibility Criteria
You may qualify if:
- Stable serum creatinine levels of at least 1.1 mg/dL or estimated creatinine clearance less than 60 mL/min
- Scheduled for diagnostic, elective cardiac angiography
You may not qualify if:
- Serum creatinine levels \>8.0 mg/dL
- Change in serum creatinine levels of at least 0.5 mg/dL during the previous 24 hours
- Preexisting dialysis
- Multiple myeloma or other myeloproliferative disease
- Current CHF or recent history of flash pulmonary edema
- Current myocardial infarction
- Symptomatic hypokalemia
- Uncontrolled hypertension (treated systolic blood pressure \>200 mmHg or diastolic blood pressure \>100mmHg)
- Exposure to radiocontrast within 7 days the study
- Emergency Catheterization
- Allergy to radiographic contrast
- Pregnancy
- Administration of dopamine, mannitol, fenoldapam, or N-acetylcysteine during the time of the study
- Severe COPD
- Serum Bicarb \> 28
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Roy Cho, MD MHSA
The Western Pennsylvania Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2010
First Posted
March 25, 2010
Study Start
February 1, 2005
Primary Completion
September 1, 2009
Study Completion
February 1, 2010
Last Updated
October 4, 2019
Record last verified: 2016-11