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Does Bicarbonate in Addition to Theophylline Reduce CIN?

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02643602
First Posted: December 31, 2015
Last Update Posted: January 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Technische Universität München
  Purpose

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.


Condition Intervention
Radiographic Contrast Agent Nephropathy Other: Hydration with bicarbonate in addition to theophylline Other: Hydration with sodium chloride in addition to theophylline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Does Bicarbonate in Addition to Theophylline Reduce Contrast Induced Nephropathy Compared to Sodium Chloride?

Resource links provided by NLM:


Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • Contrast induced nephropathy [ Time Frame: 48 hours ]
    Raise in serum creatinine of ≥25% or ≥0.5 mg/dl


Secondary Outcome Measures:
  • Change of serum creatinine levels over time [ Time Frame: 48 hours ]
  • Change of creatinine clearance over time [ Time Frame: 48 hours ]
  • Change in blood pH [ Time Frame: 48 hours ]
  • Change in blood bicarbonate-concentration [ Time Frame: 48 hours ]
  • Change in blood sodium-concentration [ Time Frame: 48 hours ]
  • Change in urine pH [ Time Frame: 48 hours ]
  • Change in urine bicarbonate-concentration [ Time Frame: 48 hours ]
  • Change in urine pH sodium-concentration [ Time Frame: 48 hours ]
  • Incidence of patients with need for dialysis [ Time Frame: 30 days ]
    The patients medical record was reviewed to determine whether dialysis was performed within 30 days after contrast media application.


Enrollment: 152
Study Start Date: December 2005
Study Completion Date: December 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bicarbonate and theophylline
Hydration with bicarbonate in addition to theophylline
Other: Hydration with bicarbonate in addition to theophylline
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
Active Comparator: Sodium and theophylline
Hydration with sodium chloride in addition to theophylline
Other: Hydration with sodium chloride in addition to theophylline
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

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02643602


Sponsors and Collaborators
Technische Universität München
Investigators
Principal Investigator: Wolfgang Huber, M.D. 2. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München
  More Information

Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT02643602     History of Changes
Other Study ID Numbers: NaBicTheo
First Submitted: December 23, 2015
First Posted: December 31, 2015
Last Update Posted: January 1, 2016
Last Verified: December 2015

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Theophylline
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents