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

This study is currently recruiting participants.
Verified July 2016 by University Hospital, Clermont-Ferrand
Sponsor:
ClinicalTrials.gov Identifier:
NCT01763853
First Posted: January 9, 2013
Last Update Posted: July 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
R2D2 Retinoids, Reproduction Developmental Diseases
Université d'Auvergne
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
  Purpose

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.


Condition Intervention Phase
Acute Respiratory Distress Syndrome (ARDS) Hypovolemia Pulmonary Edema Drug: 4% albumin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Impact of Fluid Resuscitation Therapy on Pulmonary Edema as Measured by Alveolar Fluid Clearance in Patients With Acute Respiratory Distress Syndrome (ARDS)

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Rate of alveolar fluid clearance [ Time Frame: one hour after administration of fluid resuscitation ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 70
Study Start Date: December 2012
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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).
Drug: 4% albumin

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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01763853


Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick Lacarin    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
R2D2 Retinoids, Reproduction Developmental Diseases
Université d'Auvergne
Investigators
Principal Investigator: Matthieu JABAUDON University Hospital, Clermont-Ferrand
  More Information

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01763853     History of Changes
Other Study ID Numbers: CHU-0134
First Submitted: December 10, 2012
First Posted: January 9, 2013
Last Update Posted: July 29, 2016
Last Verified: July 2016

Keywords provided by University Hospital, Clermont-Ferrand:
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

Additional relevant MeSH terms:
Syndrome
Edema
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Pulmonary Edema
Hypovolemia
Disease
Pathologic Processes
Signs and Symptoms
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury