Does Bicarbonate in Addition to Theophylline Reduce CIN?

Not Applicable

Completed

• Conditions: Radiographic Contrast Agent Nephropathy
• Interventions: Other: Hydration with bicarbonate in addition to theophylline; Other: Hydration with sodium chloride in addition to theophylline

• Registration Number: NCT02643602
• Lead Sponsor: Technical University of Munich

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Primary Completion: 2012-06
• Study Completion: 2012-12
• Status Verified: 2015-12
• Study First Submitted: 2015-12-23
• Study First Submitted QC: 2015-12-29
• Last Update Submitted: 2015-12-30
• Study First Posted: 2015-12-31
• Last Update Posted: 2016-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bicarbonate and theophylline	Hydration with bicarbonate in addition to theophylline	Hydration with bicarbonate in addition to theophylline
Sodium and theophylline	Hydration with sodium chloride in addition to theophylline	Hydration with sodium chloride in addition to theophylline

Primary Outcome Measures

Name	Time	Method
Contrast induced nephropathy	48 hours	Raise in serum creatinine of ≥25% or ≥0.5 mg/dl

Secondary Outcome Measures

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