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Completed

NCT Number: NCT00531765

Sodium Bicarbonate in Preventing Contrast Induced Nephropathy

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Faisal Specialist Hospital & Research Center

Riyadh, 11211, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

sodium bicarbonate infusion

Other

short infusion of sodium bicarbonate

Primary outcomes

  1. Incidence of Contrast Induced nephropathy

    Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

King Faisal Specialist Hospital & Research Center

Other

Registry information

Official study title

Sodium Bicarbonate in Preventing Contrast Induced Nephropathy (SIPCIN): A Randomized Controlled Study

Acronym: SIPCIN

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Sep 19, 2007
Registry last updated
Jul 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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