NCT04037644

Volume Expansion With Albumin vs. Crystalloid and Expiratory Lung Impedance

Effect of Volume EXpansion witH ALbumin vs. Crystalloid on EIT-derived Expiratory Lung Impedance in Critically Ill, Hemodynamically Unstable Patients. A Single-blind, Randomized and Controlled Study

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: University of Milan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Circulatory Failure

Interventions

Type	Name	Description
PROCEDURE	Fluid loading with Albumin	Fluid loading with 200 ml of 4% Albumin to reverse acute circulatory failure
PROCEDURE	Fluid loading with Ringer Lactate	Fluid loading with 5 ml per kg of actual body weight to reverse acute circulatory failure

Timeline

• Start date: 2019-07-24
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2019-07-30
• Last updated: 2019-07-30

Locations

1 site across 1 country: Italy