PatientsVille.com LogoPatientsVille.com

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)

Acute Respiratory Distress Syndrome (ARDS) research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Acute Respiratory Distress Syndrome (ARDS)

Hypovolemia

Pulmonary Edema

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:4% albumin

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

albuminThe 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).

crystalloidThe 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).

Study Status

Recruiting

Start Date: December 2012

Completed Date: May 2017

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Rate of alveolar fluid clearance

Secondary Outcome: Extra-vascular lung water

Study sponsors, principal investigator, and references

Principal Investigator: Matthieu JABAUDON

Lead Sponsor: University Hospital, Clermont-Ferrand

Collaborator: R2D2 Retinoids, Reproduction Developmental Diseases

More information:https://clinicaltrials.gov/show/NCT01763853

Discuss Oedema