Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 3H8, Canada
NCT Number: NCT06411080
Fluid expansion with isotonic crystalloids is a first-line intervention in the treatment of patients with acute kidney injury (AKI). While it is generally accepted that the timely correction of kidney hypoperfusion will minimize the extent of injury as well as potentially facilitate recovery, there are potential harms involved in indiscriminate administration of intravenous fluids. Although anticipating fluid tolerance is part of the clinical evaluation of a patient for whom intravenous fluid therapy is considered, it has been suggested that using Point-Of-Care ultrasound (POCUS) may enable the early identification of patients with a high-risk of congestive complications and guide clinical decisions with greater precision[1]. However, it has not been shown that providing this information in the context of AKI result in a change in management or a prevention of complications.
This single-center pilot randomized controlled trial aim to determine the feasibility of comparing a management including a POCUS evaluation of fluid tolerance to usual care in non-critically ill patients with AKI. In the intervention group, a POCUS evaluation will be performed and interpreted by experienced staff producing a report that will be presented to the attending care team. This assessment will be repeated 48-72 hours later. The primary aim of the study will be to establish the feasibility of this intervention. Secondary objectives will include determining the difference between the intervention arm and the control arm in relationship with fluid administration, diuretic use, evolution of kidney function, and intensification of care.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Montreal, Quebec, H2X 3H8, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Lung ultrasound for the assessment of B-line artifact and pleural effusion combined with abdominal ultrasound for VExUS assessment. The imaging study will be reviewed by an expert for will generate a report with interpretation regarding the risk of fluid administration. The assessment will be performed at baseline and after 48 hours after randomization.
Time frame: 30 days
: Ultrasound assessments were performed as planned and the reports were generated and transmitted to the attending care team in the prespecified periods.
Time frame: 5 days
Amount of fluid in mL received
Time frame: 5 days
defined as the use of loop diuretics
Time frame: 5 days
Kinetic estimated glomerular filtration rate (KeGFR) will be derived from serial measurements in serum creatinine
Time frame: 5 days
Progression to a higher stage of AKI will be defined as any increase in the KDIGO staging criteria of increase in creatinine:
Operational definition: Increase in at least one level compared to baseline AKI staging during the first 5 days:
Stage 1: Increase in serum creatinine by ≥26.5 µmol/L within 48 hours or increase to 1.5-1.9 times baseline within the last 7 days.
Stage 2: Increase in serum creatinine to 2.0-2.9 times baseline. Stage 3: Increase in serum creatinine to ≥3.0 times baseline or increase to ≥354 µmol/L, Stage 3D: Initiation of renal replacement therapy.
Time frame: 10 days
composite endpoint defined as the occurrence of at least one of the following events occurring within 10 days after randomization: death from any cause, intervention of the rapid response team, admission to the intensive care unit, initiation of non-invasive positive pressure ventilation, initiation of renal replacement therapy. (Binary - Yes/no)
Time frame: 5 days
median values of shear-wave propagation speed in m/sec obtained by shear-wave elastography assessment of the respective organ parenchyma.
Time frame: 5 days
be reported on a sliding scale from 0 to 5. A score of 0 will mean that the information is considered useless while a score of 5 will mean that the information provided had a critical impact of clinical management. (Continuous - points)
Centre hospitalier de l'Université de Montréal (CHUM)
Other
UltraSound Evaluation of Fluid tOleRanCE for Acute Kidney Injury: A Pilot Randomized Controlled Trial
Acronym: USE-the-FORCE
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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