Does Bicarbonate in Addition to Theophylline Reduce CIN?

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

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 Overview

• Status: Completed
• Conditions: Radiographic Contrast Agent Nephropathy
• Intervention / Treatment: Other: Hydration with bicarbonate in addition to theophylline; Other: Hydration with sodium chloride in addition to theophylline

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contrast induced nephropathy	Raise in serum creatinine of ≥25% or ≥0.5 mg/dl	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The patients medical record was reviewed to determine whether dialysis was performed within 30 days after contrast media application.	30 days

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Investigators: Principal Investigator: Wolfgang Huber, M.D., 2. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: December 23, 2015
• First Submitted That Met QC Criteria: December 29, 2015
• First Posted (Estimate): December 31, 2015

Study Record Updates

• Last Update Posted (Estimate): January 1, 2016
• Last Update Submitted That Met QC Criteria: December 30, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Kidney Diseases; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Theophylline
• Other Study ID Numbers: NaBicTheo