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Completed

NCT Number: NCT00700375

Prevention of Contrast-Induced Nephropathy With Sodium Bicarbonate Bolus Injection

This study is to investigate the effect of Sodium Bicarbonate bolus injection in patients undergoing an emergent coronary procedure for prevention of contrast-induced nephropathy.

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Key information

Conditions

Emergent Coronary Procedure

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Osaka General Medical Center

Osaka, 558-8558, Japan

About this study

This study is to investigate the effect of Sodium Bicarbonate bolus injection in patients undergoing an emergent coronary procedure for prevention of contrast-induced nephropathy.The End point is development of contrast-induced nephropathy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing an emergent coronary procedure(within 60 minutes from admission)

Exclusion criteria

  • On dialysis
  • Pregnancy
  • Past use of bicarbonate or N-Acetyl-Cystein in 48hr
  • Past exposure to contrast media in 48hr
  • Circulatory insufficiency with lactic acidosis.

Treatment and study plan

Sodium bicarbonate

Drug

8.4%sodium bicarbonate 0.5ml/kg bolus injection before procedure and hydration with 154mEq/l sodium bicarbonate 1ml/kg/Hr for 6 hours after the procedure

Sodium Chloride

Drug

8.4%sodium bicarbonate 0.5ml/kg bolus injection before procedure and hydration with 154mEq/l sodium bicarbonate 1ml/kg/Hr for 6 hours after the procedure

Primary outcomes

  1. Occurrence of Contrast-induced Nephropathy

    Time frame: after procedure and 1,2-3day after procedure

    The primary endpoint was the occurrence of contrast-induced nephropathy, defined as an increase >0.5 mg/dl or >25% in serum Cr concentration within 2 days of the procedure compared to the baseline level.

Sponsors and collaborators

Lead sponsor

Osaka General Medical Center

Other

Registry information

Official study title

Prevention of Contrast-Induced Nephropathy With Sodium Bicarbonate Bolus Injection in Patients Undergoing an Emergent Coronary Procedure

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 18, 2008
Registry last updated
Jul 20, 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.