Clinical trial NCT04215042: Tailored Hydration Based on Bioimpedance Analysis for Prevention of Contrast Induced Acute Kidney Injury
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Kidney Injury
Keywords: Contrast-Induced Acute Kidney Injury
Contrast-Induced Nephropathy
Contrast-Associated Acute Kidney Injury
Contrast media
Angiography
Coronary percutaneous intervention
Lead sponsor: Ospedale Misericordia e Dolce
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: incidence of contrast induced acute kidney injury (CI-AKI)
timeFrame: 1 day
Secondary outcomes:
measure: incidence of contrast induced acute kidney injury (CI-AKI)
timeFrame: 2 days
Other outcomes:
Locations:
city: Prato
country: Italy
facility: Ospedale Santo Stefano
Study officials:
References:
citation: Maioli M, Toso A, Leoncini M, Musilli N, Bellandi F, Rosner MH, McCullough PA, Ronco C. Pre-procedural bioimpedance vectorial analysis of fluid status and prediction of contrast-induced acute kidney injury. J Am Coll Cardiol. 2014 Apr 15;63(14):1387-94. doi: 10.1016/j.jacc.2014.01.025. Epub 2014 Feb 12.
citation: Maioli M, Toso A, Leoncini M, Musilli N, Grippo G, Ronco C, McCullough PA, Bellandi F. Bioimpedance-Guided Hydration for the Prevention of Contrast-Induced Kidney Injury: The HYDRA Study. J Am Coll Cardiol. 2018 Jun 26;71(25):2880-2889. doi: 10.1016/j.jacc.2018.04.022.