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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)

Primary Purpose

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

Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
4% albumin
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome (ARDS) focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

albumin

crystalloid

Arm 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 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).

Outcomes

Primary Outcome Measures

Rate of alveolar fluid clearance

Secondary Outcome Measures

Extra-vascular lung water
Pulmonary vascular permeability index
Global enddiastolic volume index
mean arterial pressure
cardiac output
pulse pressure variation
stroke volume variation
central venous venous oxygenation
central venous pressure
PaO2
lung compliance
airways resistance
lung injury score
Plasma levels of sRAGE
Alveolar levels of sRAGE
Brain natriuretic peptide levels
Plasma osmolarity
Oncotic pressure
Electrical impedance tomography
Mortality

Full Information

First Posted
December 10, 2012
Last Updated
July 28, 2016
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
R2D2 Retinoids, Reproduction Developmental Diseases, Université d'Auvergne
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1. Study Identification

Unique Protocol Identification Number
NCT01763853
Brief Title
Impact of Fluid Resuscitation Therapy on Pulmonary Edema as Measured by Alveolar Fluid Clearance in Patients With Acute Respiratory Distress Syndrome (ARDS)
Acronym
IROCA
Official Title
Impact of Fluid Resuscitation Therapy on Pulmonary Edema as Measured by Alveolar Fluid Clearance in Patients With Acute Respiratory Distress Syndrome (ARDS)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
R2D2 Retinoids, Reproduction Developmental Diseases, Université d'Auvergne

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
albumin
Arm Type
Other
Arm 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).
Arm Title
crystalloid
Arm Type
Other
Arm 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).
Intervention Type
Drug
Intervention Name(s)
4% albumin
Primary Outcome Measure Information:
Title
Rate of alveolar fluid clearance
Time Frame
one hour after administration of fluid resuscitation
Secondary Outcome Measure Information:
Title
Extra-vascular lung water
Time Frame
one hour and three hours after administration of fluid resuscitation
Title
Pulmonary vascular permeability index
Time Frame
one hour and three hours after administration of fluid resuscitation
Title
Global enddiastolic volume index
Time Frame
one hour and three hours after administration of fluid resuscitation
Title
mean arterial pressure
Time Frame
one hour and three hours after administration of fluid resuscitation
Title
cardiac output
Time Frame
one hour and three hours after administration of fluid resuscitation
Title
pulse pressure variation
Time Frame
one hour and three hours after administration of fluid resuscitation
Title
stroke volume variation
Time Frame
one hour and three hours after administration of fluid resuscitation
Title
central venous venous oxygenation
Time Frame
one hour and three hours after administration of fluid resuscitation
Title
central venous pressure
Time Frame
one hour and three hours after administration of fluid resuscitation
Title
PaO2
Time Frame
one hour and three hours after administration of fluid resuscitation
Title
lung compliance
Time Frame
one hour and three hours after administration of fluid resuscitation
Title
airways resistance
Time Frame
one hour and three hours after administration of fluid resuscitation
Title
lung injury score
Time Frame
one hour and three hours after administration of fluid resuscitation
Title
Plasma levels of sRAGE
Time Frame
one hour and three hours after administration of fluid resuscitation
Title
Alveolar levels of sRAGE
Time Frame
one hour and three hours after administration of fluid resuscitation
Title
Brain natriuretic peptide levels
Time Frame
one hour and three hours after administration of fluid resuscitation
Title
Plasma osmolarity
Time Frame
one hour and three hours after administration of fluid resuscitation
Title
Oncotic pressure
Time Frame
one hour and three hours after administration of fluid resuscitation
Title
Electrical impedance tomography
Time Frame
one hour and three hours after administration of fluid resuscitation
Title
Mortality
Time Frame
Day 20, Day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthieu JABAUDON
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Lacarin
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr

12. IPD Sharing Statement

Learn more about this trial

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

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