Prevention of Contrast-Induced Acute Kidney Injury: Standard Versus Short Hydration Protocol in Patients With Normal Fluid Status Assessed by the Bioimpedance Analysis (The HYDRA II Study)
Overview
- Phase
- Not Applicable
- Intervention
- sodium chloride infusion
- Conditions
- Acute Kidney Injury
- Sponsor
- Ospedale Misericordia e Dolce
- Enrollment
- 1000
- Locations
- 1
- Primary Endpoint
- incidence of contrast induced acute kidney injury (CI-AKI)
- Last Updated
- 6 years ago
Overview
Brief Summary
The aim of this study was to evaluate, in patients with "normal fluid status" assessed by the bio-impedance analysis, whether two different protocol of IV isotonic saline infusion are associated with different volume expansion and differing risks for Contrast Induced Acute Kidney Injury in patients undergoing coronary angiographic procedure.
Detailed Description
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). Extracellular volume expansion at the time of contrast media administration may represent important protective strategies that play a major role in the prevention CI-AKI. Bio-impedance analysis is an inexpensive, rapid, and accurate tool for evaluating a patient's hydration status, and can be performed at the bedside within minutes \[Maioli, Journal of American College Cardiology 1014;63:1387-94\]. 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). Bio-impedance analysis IVA may represent the optimal tool to monitor the adequacy of volume expansion and protective strategy delivery. Infusing a standardized amount of fluid before the procedure may not result in the same effects in all patients. Moreover, standardized fluid infusion for 24 hours in patients that present with "normal fluid status" assessed by the bioimpedance analysis, can represent a too expensive preventive option both in terms of care and discomfort for the patient. In this study we analyze the possibility of a non-inferiority preventive protocol that involves a lower infusion of saline solution with a shorter administration time.
Investigators
Mauro Maioli
Medical Doctor - Cardiology
Ospedale Misericordia e Dolce
Eligibility Criteria
Inclusion Criteria
- •consecutive patients admitted in Cardiology Unit for coronary or peripheral angiography with "normal fluid status" assessed 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
- •no ability to evaluation the state of hydration with bio impedance
- •refused to give informed consent
Arms & Interventions
Standard hydration
All patients received standard intravenous saline hydration (0.9% sodium chloride, 1 ml/kg/h for 12 hours before and 6 hours after procedure
Intervention: sodium chloride infusion
Short hydration
All patients received shot intravenous saline hydration (3 ml/kg for 1 hour before the procedure and after 1ml/kg/h for 6 hours)
Intervention: sodium chloride infusion
Outcomes
Primary Outcomes
incidence of contrast induced acute kidney injury (CI-AKI)
Time Frame: 1 day
CI-AKI 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
- incidence of contrast induced acute kidney injury (CI-AKI)(2 days)