A Phase 4 interventional study of 4% albumin in Acute Respiratory Distress Syndrome (ARDS), Hypovolemia and Pulmonary Edema, sponsored by University Hospital, Clermont-Ferrand. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-29.
Sponsored by University Hospital, Clermont-Ferrand · Phase 4, Interventional, and Treatment
The need for fluid resuscitation (FR) in ICU patients with acute respiratory distress syndrome (ARDS) is common. Indeed, relative or absolute hypovolemia is a common phenomenon that the intensivist must recognize early and treat promptly. Fluid challenge may have adverse side effects associated with fluid administration. The diffusion within the interstitial space may favor edema formation and cause cardiac dysfunction by volume overload. Edema formation is global and may specifically alter pulmonary alveolar epithelial integrity, leading to enhanced alveolar edema and impaired gas exchange.
Currently, two types of fluids are frequently used, crystalloids and colloids. Among colloids and compared to crystalloids, albumin has the theoretical advantage of causing greater volume expansion.
We hypothesized that a fluid resuscitation therapy with albumin generates less pulmonary edema than a fluid resuscitation therapy with crystalloids.
The aim of our study is to compare alveolar fluid clearance, as a marker of alveolar edema fluid resorption, in 2 groups of patients: those treated with albumin and those treated with crystalloid.
The main objective of our prospective double blind, randomized, controlled trial is to compare the rate of alveolar fluid clearance, a marker of alveolar edema fluid resorption, in 2 groups of patients with ARDS and suffering from hypovolemia: those treated with albumin and those treated with crystalloid (fluid challenge of 7 mL/kg over 15 minutes, that can be repeated 3 times if hypovolemia persists).
The evolution of respiratory and hemodynamic parameters, as measured by transpulmonary thermodilution (extra-vascular lung water, pulmonary vascular permeability index, cardiac output, global enddiastolic volume), plasma osmolality, plasma oncotic pressure and plasma levels of brain natriuretic peptid (BNP) will be studied one hour and 3 hours after after fluid resuscitation in the two groups. In order to evaluate alveolar epithelial dysfunction in patients receiving either albumin or crystalloid, plasma and alveolar levels of sRAGE (the soluble form of the receptor for advanced glycation endproducts) will be measured by ELISA. Lung aeration and fluid-induced derecruitment will be evaluated with an electrical impedance tomograph (PulmoVista®500, Dräger).
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's planned enrollment of 70 is above the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The main objective of our prospective double blind, randomized, controlled trial is to compare the rate of alveolar fluid clearance, a marker of alveolar edema fluid resorption, in 2 groups of patients with ARDS and suffering from hypovolemia: those treated with albumin and those treated with crystalloid (fluid challenge of 7 mL/kg over 15 minutes, that can be repeated 3 times if hypovolemia persists).
Drug: 4% albumin
The main objective of our prospective double blind, randomized, controlled trial is to compare the rate of alveolar fluid clearance, a marker of alveolar edema fluid resorption, in 2 groups of patients with ARDS and suffering from hypovolemia: those treated with albumin and those treated with crystalloid (fluid challenge of 7 mL/kg over 15 minutes, that can be repeated 3 times if hypovolemia persists).
Drug: 4% albumin
Rate of alveolar fluid clearance
Time frame: one hour after administration of fluid resuscitation
Extra-vascular lung water
Time frame: one hour and three hours after administration of fluid resuscitation
Pulmonary vascular permeability index
Time frame: one hour and three hours after administration of fluid resuscitation
Global enddiastolic volume index
Time frame: one hour and three hours after administration of fluid resuscitation
mean arterial pressure
Time frame: one hour and three hours after administration of fluid resuscitation
cardiac output
Time frame: one hour and three hours after administration of fluid resuscitation
pulse pressure variation
Time frame: one hour and three hours after administration of fluid resuscitation
stroke volume variation
Time frame: one hour and three hours after administration of fluid resuscitation
central venous venous oxygenation
Time frame: one hour and three hours after administration of fluid resuscitation
central venous pressure
Time frame: one hour and three hours after administration of fluid resuscitation
PaO2
Time frame: one hour and three hours after administration of fluid resuscitation
lung compliance
Time frame: one hour and three hours after administration of fluid resuscitation
airways resistance
Time frame: one hour and three hours after administration of fluid resuscitation
lung injury score
Time frame: one hour and three hours after administration of fluid resuscitation
Plasma levels of sRAGE
Time frame: one hour and three hours after administration of fluid resuscitation
Alveolar levels of sRAGE
Time frame: one hour and three hours after administration of fluid resuscitation
Brain natriuretic peptide levels
Time frame: one hour and three hours after administration of fluid resuscitation
Plasma osmolarity
Time frame: one hour and three hours after administration of fluid resuscitation
Oncotic pressure
Time frame: one hour and three hours after administration of fluid resuscitation
Electrical impedance tomography
Time frame: one hour and three hours after administration of fluid resuscitation
Mortality
Time frame: Day 20, Day 90
This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Respiratory Distress Syndrome→
University Hospital, Clermont-Ferrand