A Phase 2/3 interventional study of Fluid loading with Albumin and Fluid loading with Ringer Lactate in Circulatory Failure, sponsored by University of Milan. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-30.
Sponsored by University of Milan · Phase 2/3, Interventional, and Treatment
Acute circulatory failure reduces oxygen delivery below cellular requirements, potentially leading to organ failure. Intravenous fluids are generally administered with the aim of increasing cardiac output and restore organ perfusion. Nevertheless, only 50% of patients increase their cardiac output, while in the remainder not only does fluid loading provide no benefit but it also leads to volume overload (peripheral and pulmonary edema).
There are two types of resuscitation fluids, colloids and crystalloids. Given their oncotic pressure, colloids should remain in the intravascular space, while crystalloids distribute into the whole extracellular compartment, potentially increasing the risk of tissue edema. Surprisingly, only few studies directly compared albumin and crystalloids in terms of their overload-related side effects.
Electrical impedance tomography (EIT) is a noninvasive, radiation-free, lung imaging modality, which shows lung impedance as determined by small electrical currents. An increase in intrapulmonary gas volume increases impedance, while an increase in blood or fluid volume, lowers it. EIT has a high temporal resolution, allowing to assess ventilation and perfusion in real-time. Preliminary data suggest its value to assess the variations of intrathoracic fluid in patients with pulmonary edema.
The aim of the present single-blind, randomized, controlled study is to compare the effect of a fluid challenge with albumin vs. crystalloids on EIT-derived lung impedance in a group of 56 critically ill patients with acute circulatory failure. Our hypothesis is that fluid challenge with albumin leads to a lesser decrease in lung impedance, that is a lesser extravasation of fluids into the lungs.
Hemodynamic and respiratory variables, blood samples, cardiac ultrasound and EIT measurements will be recorded before the fluid challenge, and repeated at the end of fluid infusion, 20 and 60 minutes after. Factorial Analysis of variance for repeated measures will be used to assess the effects of fluid loading
916 studies on the registry are indexed under Shock; 176 are open to participants now.
This study's planned enrollment of 56 is below the median of 77 across 540 interventional studies indexed under Shock.
Browse Shock studies →University of Milan is the lead sponsor of 177 studies on the registry; 27 are open to participants now.
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Acute circulatory failure will be defined as the presence of a systolic blood pressure (SBP) ≤90 mmHg or mean arterial pressure (MAP) ≤70 mmHg or requiring vasopressors to maintain SBP >90 mmHg or MAP >70 mmHg, along with one or more of the following: 1) urinary flow ≤0.5 mL/kg/h for ≥2 hours, 2) heart rate ≥100 beats per minute, 3) presence of skin mottling, 4) blood lactate concentration ≥2 mmol/L, 5) oxygen saturation in the central venous blood \<65%.
Exclusion Criteria:
fluid loading with 200 mL of 4% albumin over a 10' interval
Procedure: Fluid loading with Albumin
fluid loading with 5 mL/kg actual body weight of Ringer Lactate over a 10' interval
Procedure: Fluid loading with Ringer Lactate
Fluid loading with 200 ml of 4% Albumin to reverse acute circulatory failure
Fluid loading with 5 ml per kg of actual body weight to reverse acute circulatory failure
Change in lung impedance
Reduction in EIT-derived end-expiratory lung impedance after the fluid challenge in the group of patients who will receive albumin as compared to patients who will receive crystalloids
Time frame: Day 1
Comparison of the change expiratory lung impedance, as assessed by EIT, in fluid responders and non-responders
Comparison of the change in end-expiratory lung impedance, as assessed by EIT, after the fluid challenge with albumin or Ringer Lactate, in patient who will respond to the fluid challenge with an increase in their stroke volume, as compared to those who will not (non-responders)
Time frame: Day 1
Effect of fluid loading with albumin or Ringer Lactate on the change in arterial blood oxygenation
Assesment of the reduction in oxygenation, as assessed by blood gas analysis, after the fluid challenge in the group of patients who will receive albumin as compared to patients who will receive crystalloids, and its relationship with the change in expiratory lung impedance, as assessed by EIT
Time frame: Day 1
Plan to share: No
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University of Milan