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Completed

NCT Number: NCT00770614

Hydration and Contrast-Induced Nephropathy in Primary Angioplasty

The purpose of this study is to determine whether hydration with sodium bicarbonate is more effective than hydration with sodium chloride to prevent contrast induced nephropathy in patients undergoing Primary Coronary Intervention for Acute ST Elevation Myocardial Infarction.

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Key information

Conditions

Contrast Induced Nephropathy

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ospedale Misericordia e Dolce

Prato, 59100, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients with Acute ST Elevation Myocardial Infarction submitted to Primary Intervention

Exclusion criteria

  • refusal to consent
  • previous contrast exposure within 72 hours

Treatment and study plan

Sodium Bicarbonate Solution

Drug

154 mEq/L in dextrose and H2O

Isotonic saline

Drug

0.9% sodium chloride

Placebo

Drug

Placebo

Primary outcomes

  1. Absolute increase of at least 0.5 mg/dl from the baseline value in serum creatinine concentration or a relative increase ≥ 25% over baseline serum creatinine within 5 days after contrast agent administration

    Time frame: within 5 days after contrast exposure

Secondary outcomes

  1. Adverse clinical events within 1 month, including in-hospital death and need for dialysis or hemofiltration

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Ospedale Misericordia e Dolce

Other

Registry information

Official study title

Hydration and Contrast-Induced Nephropathy in Primary Angioplasty. A Randomized, Placebo Controlled, Trial.

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Oct 10, 2008
Registry last updated
May 8, 2012

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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