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Completed

NCT Number: NCT01172353

Sodium Bicarbonate for Prevention of Contrast-Induced Nephropathy

The purpose of this study is to determine whether hydration with sodium bicarbonate is superior to hydration with saline to prevent contrast-induced nephropathy.

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Key information

Conditions

Renal Failure Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

São Lucas Hospital - PUCRS University

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • serum creatinine > 1.1 mg/dL
  • glomerular filtration rate (GFR) < 50 mL/min

Exclusion criteria

  • age < 18 years
  • use of radiographic contrast media during the last 21 days
  • history of dialysis
  • cardiac insufficiency class III-IV
  • emergency procedures

Treatment and study plan

Sodium bicarbonate

Drug

hydration with sodium bicarbonate 1ml/Kg/h for 6 hours

Saline

Drug

hydration with saline 1ml/Kg/h for 6 hours

Primary outcomes

  1. Contrast-induced Nephropathy

    Time frame: 48 hours

    rise in serum creatinine >0,5mg/dl

Secondary outcomes

  1. Dialysis During Hospitalization

    Time frame: During hospitalization

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

Hospital Sao Lucas da PUCRS

Other

Registry information

Official study title

Hydration With Sodium Bicarbonate for Prevention of Contrast-Induced Nephropathy: A Multicenter Clinical Trial

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Jul 29, 2010
Registry last updated
Feb 19, 2014

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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