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

Primary Purpose

Contrast Induced Nephropathy

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Oral hydration
Oral sodium bicarbonate
Intravenous Hydration
Intravenous sodium bicarbonate
Sponsored by
The Western Pennsylvania Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Contrast Induced Nephropathy focused on measuring Contrast induced nephropathy, Percutaneous transluminal coronary angioplasty, chronic kidney disease, Prevention, Equivalence

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Western Pennsylvania Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Intravenous Hydration

Intravenous hydration and sodium bicarbonate

Oral hydration

Oral hydration and oral sodium bicarbonate

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Length of Hospital Stay
Defined as number of days in the hospital.
In-Hospital Mortality
Any cause of mortality
Aspiration
Defined as oxygen saturation less than 92% by pulse oximetry.
Hypotension
Defined as a systolic blood pressure less than 100 mmHg by conventional measuring methods.

Full Information

First Posted
February 25, 2010
Last Updated
October 1, 2019
Sponsor
The Western Pennsylvania Hospital
Collaborators
West Penn Allegheny Health System
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1. Study Identification

Unique Protocol Identification Number
NCT01093131
Brief Title
Oral Versus Intravenous Hydration to Prevent Contrast Induced Nephropathy
Acronym
HYDRATE
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

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Investigator left institution
Study Start Date
February 2005 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Western Pennsylvania Hospital
Collaborators
West Penn Allegheny Health System

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contrast Induced Nephropathy
Keywords
Contrast induced nephropathy, Percutaneous transluminal coronary angioplasty, chronic kidney disease, Prevention, Equivalence

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravenous Hydration
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intravenous hydration and sodium bicarbonate
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Oral hydration
Arm Type
Active Comparator
Arm Description
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
Arm Title
Oral hydration and oral sodium bicarbonate
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Oral hydration
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Oral sodium bicarbonate
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Intravenous Hydration
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Intravenous sodium bicarbonate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Contrast Induced Nephropathy
Description
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.
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Length of Hospital Stay
Description
Defined as number of days in the hospital.
Time Frame
72 hours
Title
In-Hospital Mortality
Description
Any cause of mortality
Time Frame
72 hours
Title
Aspiration
Description
Defined as oxygen saturation less than 92% by pulse oximetry.
Time Frame
72 hours
Title
Hypotension
Description
Defined as a systolic blood pressure less than 100 mmHg by conventional measuring methods.
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roy Cho, MD MHSA
Organizational Affiliation
The Western Pennsylvania Hospital
Official's Role
Study Director
Facility Information:
Facility Name
The Western Pennsylvania Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.wpahs.org
Description
Western Pennsylvania Allegheny Health System

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