Does Bicarbonate in Addition to Theophylline Reduce CIN?

Technical University of Munich152 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

152

Conditions

Radiographic Contrast Agent Nephropathy

Interventions

Hydration with sodium chloride in addition to theophyllineOTHER

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Contrast induced nephropathy

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

Time frame: 48 hours

Secondary Outcomes

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

The patients medical record was reviewed to determine whether dialysis was performed within 30 days after contrast media application.

Time frame: 30 days