Does Bicarbonate in Addition to Theophylline Reduce CIN?

Radiographic Contrast Agent Nephropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02643602
• Other study ID #: NaBicTheo
• Status: Completed
• Phase: N/A
• First received: December 23, 2015
• Last updated: December 30, 2015
• Start date: December 2005
• Est. completion date: December 2012

Study information

• Verified date: December 2015
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: December 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Diseases
• Radiographic Contrast Agent Nephropathy

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contrast induced nephropathy	Raise in serum creatinine of =25% or =0.5 mg/dl	48 hours	Yes
Secondary	Change of serum creatinine levels over time		48 hours	Yes
Secondary	Change of creatinine clearance over time		48 hours	Yes
Secondary	Change in blood pH		48 hours	No
Secondary	Change in blood bicarbonate-concentration		48 hours	No
Secondary	Change in blood sodium-concentration		48 hours	No
Secondary	Change in urine pH		48 hours	No
Secondary	Change in urine bicarbonate-concentration		48 hours	No
Secondary	Change in urine pH sodium-concentration		48 hours	No
Secondary	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	No