Does Bicarbonate in Addition to Theophylline Reduce CIN?

Technical University of Munich

Status

Completed

Conditions

Radiographic Contrast Agent Nephropathy

Treatments

Other: Hydration with bicarbonate in addition to theophylline

Other: Hydration with sodium chloride in addition to theophylline

Study type

Interventional

Funder types

Other

Identifiers

NCT02643602

NaBicTheo

Details and patient eligibility

About

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.

Enrollment

152 patients

Sex

All

Ages

18+ years old

Volunteers

No 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