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NCT Number: NCT02225431

Personalized Versus Standard Hydration for Prevention of CI-AKI: a Randomized Trial With Bioimpedance Analysis

The aim of this study was to evaluate, in patients with "lower fluid status" defined by bioimpedance analysis, whether two different protocol of IV isotonic saline infusion are associated with different volume expansion and differing risks for CI-AKI in patients undergoing coronary angiographic procedures.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ospedale Santo Stefano

Prato, 59100, Italy

About this study

Iodinated contrast media are a well-recognized cause of iatrogenic acute kidney injury in patients undergoing imaging diagnostic or therapeutic procedures (contrast-induced acute kidney injury, CI-AKI).

Several protocols have been tested for the prevention of CI-AKI, including periprocedural hydration with isotonic saline or sodium bicarbonate, antioxidant compounds, use of low- or iso-osmolar contrast agents, and hemofiltration or dialysis. The results of these interventions and strategies have been often disappointing or inconclusive and intravenous volume expansion remains the only therapy of undisputed efficacy.

Bioimpedance analysis is an inexpensive, rapid, and accurate tool for evaluating a patient's hydration status, and can be performed at the bedside within minutes [Maioli, JACC 1014;63:1387-94]. In this study we defined patients with "lower fluid status" with high risk of CI-AKI (Male with resistance/height ratio > 315 Ohm/meter and Female > 380 Ohm/meter). BIVA may represent the optimal tool to monitor the adequacy of volume expansion and protective strategy delivery.

However, most hydration protocols rely on a "one size fits all" approach with a fixed volume and time of infusion without an assessment of whether adequate hydration was achieved. This practice risks either under-hydration without true amelioration of CI-AKI risk or over-hydration with risk of adverse outcomes.

Thus, on the basis of results of BIVA testing a randomized fluid infusion plan is prescribed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • consecutive patients admitted in Cardiology Unit for coronary or peripheral angiography with "lower fluid status" defined on the basis bio-impedance analysis (Male with resistance/height ratio > 315 Ohm/meter and Female > 380 Ohm/meter).

Exclusion criteria

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

Treatment and study plan

sodium chloride infusion

Drug

Primary outcomes

  1. Incidence of contrast-induced acute kidney injury

    Time frame: 1 day

    contrast acute kidney injury is defined as an increase in serum Cystatin C concentration 10% above the baseline value at 24 hours after administration of 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

Other outcomes

  1. Incidence of contrast-induced acute kidney injury

    Time frame: 2 days

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

Sponsors and collaborators

Lead sponsor

Ospedale Misericordia e Dolce

Other

Registry information

Official study title

Personalized Versus Standard Hydration for Prevention of Contrast Induced Acute Kidney Injury. A Randomized Trial With Bioimpedance Analysis.

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 26, 2014
Registry last updated
Oct 16, 2015

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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