Sodium Bicarbonate versus Saline for the prevention of Contrast Induced Nephropathy in patients undergoing angiography

Sodium Bicarbonate versus Saline for the prevention of Contrast Induced Nephropathy in patients undergoing angiography - The Helios Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37953

Enrollment

346

Registered

2010-12-13

Start date

2010-12-03

Completion date

Unknown

Last updated

2024-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

contrast induced nephropathy contrast medium induced nephropathy

Interventions

• Group 1: Pre hydration with sodium bicarbonate 1.4% 250 mL 1 hour prior to angiography. • Group 2: Pre and post hydration with saline 0.9% 1000 ml each during 3-12 hours.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - patients undergoing angiography with intra arterial contrast administration - eGFR (estimated glomerular filtration rate)

Exclusion criteria

Exclusion criteria: - age

Design outcomes

Primary

Measure	Time frame
• mean rise in serum creatinine 2-4 days after angiography	—

Secondary

Measure	Time frame
• CIN defined as an increase in serum creatinine > 25% or > 44 µmol/l after 2-4 days; • CIN defined as an increase in serum creatinine > 25% or > 44 µmol/l after 2 months; • Indication for dialysis due too CIN; • Congestive heart failure due to rapid volume expansion with an indication for treatment with diuretics.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)