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.

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01093131

Acronym

HYDRATE

Enrollment

Registered

2010-03-25

Start date

2005-02-28

Completion date

2010-02-28

Last updated

2019-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contrast Induced Nephropathy

Keywords

Contrast induced nephropathy, Percutaneous transluminal coronary angioplasty, chronic kidney disease, Prevention, Equivalence

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.

Interventions

OTHEROral 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

DRUGOral 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

OTHERIntravenous 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.

DRUGIntravenous 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.

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Contrast Induced Nephropathy	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

Measure	Time frame	Description
Length of Hospital Stay	72 hours	Defined as number of days in the hospital.
In-Hospital Mortality	72 hours	Any cause of mortality
Aspiration	72 hours	Defined as oxygen saturation less than 92% by pulse oximetry.
Hypotension	72 hours	Defined as a systolic blood pressure less than 100 mmHg by conventional measuring methods.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026