Sodium Bicarbonate in Preventing Contrast Induced Nephropathy (SIPCIN)

King Faisal Specialist Hospital & Research Center

Status: Completed

Conditions: Contrast Induced Nephropathy

Treatments: Other: sodium bicarbonate infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT00531765

RAC 2071003

Details and patient eligibility

About

We plan to conduct an open-label, randomized, stratified, parallel-group study to compare normal saline infusion to sodium bicarbonate infusion.

Full description

We plan to conduct an open-label, randomized, stratified, parallel-group study to compare normal saline infusion to sodium bicarbonate infusion. 220 adult patients scheduled for routine cardiac catheterization will be enrolled. They will stratified according to the presence or absence of DM, or an estimated GER of less than 60 ml/hr before being block-randomized to the two groups. The incidence of CIN will be determined based on the average of two measurements of creatinine level before and 48 hours after the procedure, and an increase of 25% or 0.5 mg/dL (44.2 umol/L) or more.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

All adult patients (18 years and above) who are scheduled for cardiac catechization and have abnormal but stable renal function will be eligible for enrollment. Abnormal renal function is defined as a creatinine level exceeding the normal range (more than 115 or 96 um/L in males and females, respectively, in KFSH&RC laboratories) or eGFR less than 60 ml/min

Exclusion criteria

Patients who fall under any of the following categories will be excluded:

• Acute renal failure
• Cardiogenic shock
• Emergency cardiac catheterization
• Preexisting peritoneal or hemodialysis
• Pregnancy
• Recent exposure to contrast agent within the last 3 days
• Allergy to contrast or any of the above treatment
• Renal transplant,
• Patients who received dopamine, mannitol, theophyllin or other medications known to affect renal function within one week from cardiac cath
• Pulmonary edema / congestive heart failure
• Use of N-acetylcystein
• Patents on NSAIDS who can not stop using them for 48 hrs before and 48 hrs after procedure (except Aspirin).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

1

Active Comparator group

Description:

hydration with normal saline

Treatment:

Other: sodium bicarbonate infusion

2

Experimental group

Description:

hydration with sodium bicarbonate

Treatment:

Other: sodium bicarbonate infusion