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

This study has been completed.
Sponsor:
Collaborator:
West Penn Allegheny Health System
Information provided by (Responsible Party):
The Western Pennsylvania Hospital
ClinicalTrials.gov Identifier:
NCT01093131
First received: February 25, 2010
Last updated: May 29, 2014
Last verified: May 2014

February 25, 2010
May 29, 2014
February 2005
September 2009   (final data collection date for primary outcome measure)
Contrast Induced Nephropathy [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01093131 on ClinicalTrials.gov Archive Site
  • Length of Hospital Stay [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
    Defined as number of days in the hospital.
  • In-Hospital Mortality [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
    Any cause of mortality
  • Aspiration [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
    Defined as oxygen saturation less than 92% by pulse oximetry.
  • Hypotension [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
    Defined as a systolic blood pressure less than 100 mmHg by conventional measuring methods.
Same as current
Not Provided
Not Provided
 
Oral Versus Intravenous Hydration to Prevent Contrast Induced Nephropathy
Oral Hydration and Alkalinization is Non-Inferior to Intravenous Therapy for Prevention of Contrast Induced Nephropathy in Patients With Chronic Kidney Disease.

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Contrast Induced Nephropathy
  • 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
  • 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: 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.
    Intervention: Other: Intravenous Hydration
  • 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.
    Interventions:
    • Other: Intravenous Hydration
    • Drug: Intravenous sodium bicarbonate
  • 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
    Intervention: Other: Oral hydration
  • 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
    Interventions:
    • Other: Oral hydration
    • Drug: Oral sodium bicarbonate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
91
February 2010
September 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01093131
04-11-097-DT / WPCI 2009-28
Yes
The Western Pennsylvania Hospital
The Western Pennsylvania Hospital
West Penn Allegheny Health System
Study Director: Roy Cho, MD MHSA The Western Pennsylvania Hospital
The Western Pennsylvania Hospital
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP