Skip to content

Impact of Fluid Resuscitation Therapy on Pulmonary Edema as Measured by Alveolar Fluid Clearance in Patients With Acute Respiratory Distress Syndrome (ARDS)

Impact of Fluid Resuscitation Therapy on Pulmonary Edema as Measured by Alveolar Fluid Clearance in Patients With Acute Respiratory Distress Syndrome (ARDS)

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01763853
Acronym
IROCA
Enrollment
70
Registered
2013-01-09
Start date
2012-12-31
Completion date
2017-05-31
Last updated
2016-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome (ARDS), Hypovolemia, Pulmonary Edema

Keywords

Acute respiratory distress syndrome (ARDS), Pulmonary edema, Alveolar fluid clearance, Alveolar epithelial dysfunction, Receptor for advanced glycation end-products (RAGE), Fluid resuscitation therapy, Hypovolemia, Crystalloid, Hydroxyethyl Starch, Intensive care unit

Brief summary

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.

Detailed description

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).

Interventions

DRUG4% albumin

Sponsors

R2D2 Retinoids, Reproduction Developmental Diseases
CollaboratorOTHER
Université d'Auvergne
CollaboratorOTHER
University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* ICU patients under mechanical ventilation * Patients within the first 24 hours after onset of moderate or severe ARDS, as defined by the Berlin definition (JAMA. 2012;307(23):2526-2533) * Hypovolemia requiring fluid resuscitation therapy

Exclusion criteria

* Pregnancy * Age under 18 * Refusal of the protocol * Contraindications for the use of Voluven© or Ringer Lactate© * Contraindications for femoral artery catheterization or subclavian venous catheterization

Design outcomes

Primary

MeasureTime frame
Rate of alveolar fluid clearanceone hour after administration of fluid resuscitation

Secondary

MeasureTime frame
Pulmonary vascular permeability indexone hour and three hours after administration of fluid resuscitation
Global enddiastolic volume indexone hour and three hours after administration of fluid resuscitation
mean arterial pressureone hour and three hours after administration of fluid resuscitation
cardiac outputone hour and three hours after administration of fluid resuscitation
pulse pressure variationone hour and three hours after administration of fluid resuscitation
stroke volume variationone hour and three hours after administration of fluid resuscitation
central venous venous oxygenationone hour and three hours after administration of fluid resuscitation
central venous pressureone hour and three hours after administration of fluid resuscitation
PaO2one hour and three hours after administration of fluid resuscitation
Extra-vascular lung waterone hour and three hours after administration of fluid resuscitation
airways resistanceone hour and three hours after administration of fluid resuscitation
lung injury scoreone hour and three hours after administration of fluid resuscitation
Plasma levels of sRAGEone hour and three hours after administration of fluid resuscitation
Alveolar levels of sRAGEone hour and three hours after administration of fluid resuscitation
Brain natriuretic peptide levelsone hour and three hours after administration of fluid resuscitation
Plasma osmolarityone hour and three hours after administration of fluid resuscitation
Oncotic pressureone hour and three hours after administration of fluid resuscitation
Electrical impedance tomographyone hour and three hours after administration of fluid resuscitation
MortalityDay 20, Day 90
lung complianceone hour and three hours after administration of fluid resuscitation

Countries

France

Contacts

Primary ContactPatrick LACARIN
placarin@chu-clermontferrand.fr04 73 75 11 95

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026