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OpenTrials
Completed

NCT Number: NCT01742130

Early Hydration in Acute Myocardial Infarction

The purpose of this study is to determine whether hydration with sodium bicarbonate is more effective than hydration with sodium chloride to prevent contrast nephropathy in patients undergoing primary coronary intervention for acute ST elevation myocardial infarction.

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Key information

Conditions

Contrast Induced Acute Kidney Injury

Age range

18 year–90 year

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

  • Consecutive patients with AMI candidates for primary PCI presenting within 12 h of symptom onset with ST-segment elevation of more 1 mm in at least two contiguous leads of electrocardiogram.

Exclusion criteria

  • contrast medium administration within the 10 days
  • end-stage renal failure requiring dialysis
  • refusal to give informed consent

Treatment and study plan

Sodium Bicarbonate Solution

Drug

Other names: 154 mEq/L in dextrose and H2O

Isotonic saline

Drug

Other names: 0.9% sodium chloride

Primary outcomes

  1. Incidence of contrast-induced acute kidney injury

    Time frame: 2 days

    contrast-induced acute kidney injury is defined as an increase in serum creatinine >= 0.3 mg/dL over the baseline value within 2 days after the administration of the contrast medium

Secondary outcomes

  1. adverse clinical events

    Time frame: 1 month

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

Sponsors and collaborators

Lead sponsor

Ospedale Misericordia e Dolce

Other

Registry information

Official study title

Early Hydration in Acute Myocardial Infarction: Sodium Bicarbonate Versus Saline for the Prevention on Contrast-induced Acute Kidney Injury

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 5, 2012
Registry last updated
Nov 7, 2013

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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