Oral Versus Intravenous Hydration to Prevent Contrast Induced Nephropathy (HYDRATE)
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ClinicalTrials.gov Identifier: NCT01093131 |
Recruitment Status
:
Completed
First Posted
: March 25, 2010
Last Update Posted
: November 30, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Contrast Induced Nephropathy | Other: Oral hydration Drug: Oral sodium bicarbonate Other: Intravenous Hydration Drug: Intravenous sodium bicarbonate | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 91 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
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 Start Date : | February 2005 |
Actual Primary Completion Date : | September 2009 |
Actual Study Completion Date : | February 2010 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Intravenous Hydration
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.
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Other: Intravenous Hydration
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.
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Active Comparator: Intravenous hydration and sodium bicarbonate
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.
|
Other: Intravenous Hydration
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.
Drug: Intravenous sodium bicarbonate
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.
|
Active Comparator: Oral hydration
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
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Other: Oral hydration
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
|
Active Comparator: Oral hydration and oral sodium bicarbonate
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
|
Other: Oral hydration
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
Drug: Oral sodium bicarbonate
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
|
- Contrast Induced Nephropathy [ Time Frame: 72 hours ]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.
- Length of Hospital Stay [ Time Frame: 72 hours ]Defined as number of days in the hospital.
- In-Hospital Mortality [ Time Frame: 72 hours ]Any cause of mortality
- Aspiration [ Time Frame: 72 hours ]Defined as oxygen saturation less than 92% by pulse oximetry.
- Hypotension [ Time Frame: 72 hours ]Defined as a systolic blood pressure less than 100 mmHg by conventional measuring methods.

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Ages Eligible for Study: | 18 Years to 100 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Sodium <133

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01093131
United States, Pennsylvania | |
The Western Pennsylvania Hospital | |
Pittsburgh, Pennsylvania, United States, 15224 |
Study Director: | Roy Cho, MD MHSA | The Western Pennsylvania Hospital |
Additional Information:
Responsible Party: | The Western Pennsylvania Hospital |
ClinicalTrials.gov Identifier: | NCT01093131 History of Changes |
Other Study ID Numbers: |
04-11-097-DT / WPCI 2009-28 |
First Posted: | March 25, 2010 Key Record Dates |
Last Update Posted: | November 30, 2016 |
Last Verified: | November 2016 |
Keywords provided by The Western Pennsylvania Hospital:
Contrast induced nephropathy Percutaneous transluminal coronary angioplasty chronic kidney disease Prevention Equivalence |
Additional relevant MeSH terms:
Renal Insufficiency, Chronic Kidney Diseases Renal Insufficiency Urologic Diseases Pharmaceutical Solutions |