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OpenTrials
Completed

NCT Number: NCT02643602

Does Bicarbonate in Addition to Theophylline Reduce CIN?

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.

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Key information

Conditions

Radiographic Contrast Agent Nephropathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydration with bicarbonate in addition to theophylline

Other

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

Hydration with sodium chloride in addition to theophylline

Other

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 outcomes

  1. Contrast induced nephropathy

    Time frame: 48 hours

    Raise in serum creatinine of ≥25% or ≥0.5 mg/dl

Secondary outcomes

  1. Change of serum creatinine levels over time

    Time frame: 48 hours

  2. Change of creatinine clearance over time

    Time frame: 48 hours

  3. Change in blood pH

    Time frame: 48 hours

  4. Change in blood bicarbonate-concentration

    Time frame: 48 hours

  5. Change in blood sodium-concentration

    Time frame: 48 hours

  6. Change in urine pH

    Time frame: 48 hours

  7. Change in urine bicarbonate-concentration

    Time frame: 48 hours

  8. Change in urine pH sodium-concentration

    Time frame: 48 hours

  9. 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.

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study title

Does Bicarbonate in Addition to Theophylline Reduce Contrast Induced Nephropathy Compared to Sodium Chloride?

Important dates

Study start
2005
Primary completion
2012
Study completion
2012
First posted
Dec 31, 2015
Registry last updated
Jan 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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