Oral Versus Intravenous Hydration to Prevent Contrast Induced Nephropathy (HYDRATE)

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01093131

First Posted: March 25, 2010

Last Update Posted: November 30, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

West Penn Allegheny Health System

Information provided by (Responsible Party):

The Western Pennsylvania Hospital

Purpose

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.

Condition	Intervention	Phase
Contrast Induced Nephropathy	Other: Oral hydration Drug: Oral sodium bicarbonate Other: Intravenous Hydration Drug: Intravenous sodium bicarbonate	Phase 4


Study Type:	Interventional
Study Design:	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.

Resource links provided by NLM:

MedlinePlus related topics: Kidney Diseases

U.S. FDA Resources

Further study details as provided by The Western Pennsylvania Hospital:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.


Enrollment:	91
Study Start Date:	February 2005
Study Completion Date:	February 2010
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	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.
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	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

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

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 100 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

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

Locations


United States, Pennsylvania
The Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224

Sponsors and Collaborators

The Western Pennsylvania Hospital

West Penn Allegheny Health System

Investigators


Study Director:	Roy Cho, MD MHSA	The Western Pennsylvania Hospital

More Information

Additional Information:

Western Pennsylvania Allegheny Health System This link exits the ClinicalTrials.gov site


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 Submitted:	February 25, 2010
First Posted:	March 25, 2010
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

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