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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04037644
Other study ID # EXHALE
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date July 24, 2019
Est. completion date December 31, 2020

Study information

Verified date July 2019
Source University of Milan
Contact Davide Chiumello, MD
Phone +390281844020
Email chiumello@libero.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 56
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients >18 years with acute circulatory failure of any cause, receiving mechanical ventilation using volume-assisted control mode, without any spontaneous breathing activity, scheduled for a fluid bolus by their treating physician will be enrolled. Patients will only be included in the study once.

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:

- Patients having right ventricular dysfunction, anuria, pregnancy, presence of pneumothorax or lung emphysema, previous history of severe chronic obstructive pulmonary disease (GOLD III-IV) or contraindications to the use of EIT (e.g., presence of pacemaker or automatic implantable cardioverter-defibrillator) and impossibility to place the EIT belt in the right position (e.g., presence of surgical wounds dressing) will be excluded

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Fluid loading with Albumin
Fluid loading with 200 ml of 4% Albumin to reverse acute circulatory failure
Fluid loading with Ringer Lactate
Fluid loading with 5 ml per kg of actual body weight to reverse acute circulatory failure

Locations

Country Name City State
Italy Ospedale San Paolo - Polo Universitario, ASST Santi Paolo e Carlo Milan MI

Sponsors (1)

Lead Sponsor Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Day 1
Secondary 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) Day 1
Secondary 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 Day 1
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