Does Bicarbonate in Addition to Theophylline Reduce CIN?
Primary Purpose
Radiographic Contrast Agent Nephropathy
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hydration with bicarbonate in addition to theophylline
Hydration with sodium chloride in addition to theophylline
Sponsored by
About this trial
This is an interventional prevention trial for Radiographic Contrast Agent Nephropathy
Eligibility Criteria
Inclusion Criteria:
Increased risk for contrast induced nephropathy defined as:
- Serum creatinine level ≥ 1.1 mg/dl OR
- Serum creatinine level ≥ 0.8 mg/dl plus an additional risk factor like diabetes mellitus, renal failure in past medical history or nephrotoxic medication (aminoglycoside, vancomycin, amphotericin B, diuretic)
Exclusion Criteria:
- pre-existing renal replacement therapy
- unstable serum creatinine levels (difference of more than ±0.4 mg/dl within 3 days before contrast application)
- contraindications for theophylline or sodium bicarbonate (allergies, tachycardia, alkalosis, hypokalemia)
- additional interventions that might influence renal function
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Bicarbonate and theophylline
Sodium and theophylline
Arm Description
Hydration with bicarbonate in addition to theophylline
Hydration with sodium chloride in addition to theophylline
Outcomes
Primary Outcome Measures
Contrast induced nephropathy
Raise in serum creatinine of ≥25% or ≥0.5 mg/dl
Secondary Outcome Measures
Change of serum creatinine levels over time
Change of creatinine clearance over time
Change in blood pH
Change in blood bicarbonate-concentration
Change in blood sodium-concentration
Change in urine pH
Change in urine bicarbonate-concentration
Change in urine pH sodium-concentration
Incidence of patients with need for dialysis
The patients medical record was reviewed to determine whether dialysis was performed within 30 days after contrast media application.
Full Information
NCT ID
NCT02643602
First Posted
December 23, 2015
Last Updated
December 30, 2015
Sponsor
Technical University of Munich
1. Study Identification
Unique Protocol Identification Number
NCT02643602
Brief Title
Does Bicarbonate in Addition to Theophylline Reduce CIN?
Official Title
Does Bicarbonate in Addition to Theophylline Reduce Contrast Induced Nephropathy Compared to Sodium Chloride?
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technical University of Munich
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Contrast-induced nephropathy (CIN) is the third most frequent cause of hospital-acquired acute renal failure. Different regimes in the prophylaxis of CIN have been investigated in the last years. Recent Meta-analysis show a reduced incidence of CIN when theophylline is administered to the patients especially in patients with already existing renal impairment. Furthermore hydration with bicarbonate seems to to be superior to hydration with sodium chloride alone. The combination of the two prophylaxis has not been investigated yet.
Aim of this prospective randomized trial is to investigate the effect of hydration with sodium bicarbonate compared to saline in addition to theophylline prophylaxis which all patients receive.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiographic Contrast Agent Nephropathy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
152 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bicarbonate and theophylline
Arm Type
Experimental
Arm Description
Hydration with bicarbonate in addition to theophylline
Arm Title
Sodium and theophylline
Arm Type
Active Comparator
Arm Description
Hydration with sodium chloride in addition to theophylline
Intervention Type
Other
Intervention Name(s)
Hydration with bicarbonate in addition to theophylline
Intervention Description
0.154-molar sodium bicarbonate; 3 ml per kg bodyweight (maximum 330 ml) one hour before contrast exposure; additionally 200 mg theophylline as a short infusion; after contrast application hydration with another 1 ml per kg bodyweight per hour (maximum 110 ml per hour) for 6 hours
Intervention Type
Other
Intervention Name(s)
Hydration with sodium chloride in addition to theophylline
Intervention Description
0.9% sodium chloride; 3 ml per kg bodyweight (maximum 330 ml) one hour before contrast exposure; additionally 200 mg theophylline as a short infusion; after contrast application hydration with another 1 ml per kg bodyweight per hour (maximum 110 ml per hour) for 6 hours
Primary Outcome Measure Information:
Title
Contrast induced nephropathy
Description
Raise in serum creatinine of ≥25% or ≥0.5 mg/dl
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Change of serum creatinine levels over time
Time Frame
48 hours
Title
Change of creatinine clearance over time
Time Frame
48 hours
Title
Change in blood pH
Time Frame
48 hours
Title
Change in blood bicarbonate-concentration
Time Frame
48 hours
Title
Change in blood sodium-concentration
Time Frame
48 hours
Title
Change in urine pH
Time Frame
48 hours
Title
Change in urine bicarbonate-concentration
Time Frame
48 hours
Title
Change in urine pH sodium-concentration
Time Frame
48 hours
Title
Incidence of patients with need for dialysis
Description
The patients medical record was reviewed to determine whether dialysis was performed within 30 days after contrast media application.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Increased risk for contrast induced nephropathy defined as:
Serum creatinine level ≥ 1.1 mg/dl OR
Serum creatinine level ≥ 0.8 mg/dl plus an additional risk factor like diabetes mellitus, renal failure in past medical history or nephrotoxic medication (aminoglycoside, vancomycin, amphotericin B, diuretic)
Exclusion Criteria:
pre-existing renal replacement therapy
unstable serum creatinine levels (difference of more than ±0.4 mg/dl within 3 days before contrast application)
contraindications for theophylline or sodium bicarbonate (allergies, tachycardia, alkalosis, hypokalemia)
additional interventions that might influence renal function
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang Huber, M.D.
Organizational Affiliation
2. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Does Bicarbonate in Addition to Theophylline Reduce CIN?
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