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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
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Radiographic Contrast Agent Nephropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 23, 2015
    Last Updated
    December 30, 2015
    Sponsor
    Technical University of Munich
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    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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