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:
The Western Pennsylvania Hospital
ClinicalTrials.gov Identifier:
NCT01093131
First received: February 25, 2010
Last updated: August 2, 2011
Last verified: August 2011
  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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Factorial Assignment
Masking: 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:


Further study details as provided by The Western Pennsylvania Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Venkatraman Srinivasan M.D. FACC, West Penn Allegheny Health System
ClinicalTrials.gov Identifier: NCT01093131     History of Changes
Other Study ID Numbers: 04-11-097-DT / WPCI 2009-28
Study First Received: February 25, 2010
Last Updated: August 2, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by The Western Pennsylvania Hospital:
Contrast induced nephropathy
Percutaneous transluminal coronary angioplasty
chronic kidney disease
Prevention
Equivalence

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on April 16, 2014