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. (see Contacts and Locations)
Verified January 2013 by University Hospital, Clermont-Ferrand
Sponsor:
Collaborators:
R2D2 Retinoids, Reproduction Developmental Diseases
Diseases) - EA7281, Universite d’Auvergne Clermont 1, Clermont-Ferrand
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01763853
First received: December 10, 2012
Last updated: January 7, 2013
Last verified: January 2013
  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 Hydroxyethyl starches. Hydroxyethyl starches have the theoretical advantage of causing greater volume expansion.

We hypothesized that a fluid resuscitation therapy with hydroxyethyl starch 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 hydroxyethyl starch and those treated with crystalloid.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Extra-vascular lung water [ Time Frame: one hour and three hours after administration of fluid resuscitation ] [ Designated as safety issue: Yes ]
  • Pulmonary vascular permeability index [ Time Frame: one hour and three hours after administration of fluid resuscitation ] [ Designated as safety issue: Yes ]
  • Global enddiastolic volume index [ Time Frame: one hour and three hours after administration of fluid resuscitation ] [ Designated as safety issue: Yes ]
  • mean arterial pressure [ Time Frame: one hour and three hours after administration of fluid resuscitation ] [ Designated as safety issue: Yes ]
  • cardiac output [ Time Frame: one hour and three hours after administration of fluid resuscitation ] [ Designated as safety issue: Yes ]
  • pulse pressure variation [ Time Frame: one hour and three hours after administration of fluid resuscitation ] [ Designated as safety issue: Yes ]
  • stroke volume variation [ Time Frame: one hour and three hours after administration of fluid resuscitation ] [ Designated as safety issue: Yes ]
  • central venous venous oxygenation [ Time Frame: one hour and three hours after administration of fluid resuscitation ] [ Designated as safety issue: Yes ]
  • central venous pressure [ Time Frame: one hour and three hours after administration of fluid resuscitation ] [ Designated as safety issue: Yes ]
  • PaO2 [ Time Frame: one hour and three hours after administration of fluid resuscitation ] [ Designated as safety issue: Yes ]
  • lung compliance [ Time Frame: one hour and three hours after administration of fluid resuscitation ] [ Designated as safety issue: Yes ]
  • airways resistance [ Time Frame: one hour and three hours after administration of fluid resuscitation ] [ Designated as safety issue: Yes ]
  • lung injury score [ Time Frame: one hour and three hours after administration of fluid resuscitation ] [ Designated as safety issue: Yes ]
  • Plasma levels of sRAGE [ Time Frame: one hour and three hours after administration of fluid resuscitation ] [ Designated as safety issue: Yes ]
  • Alveolar levels of sRAGE [ Time Frame: one hour and three hours after administration of fluid resuscitation ] [ Designated as safety issue: Yes ]
  • Brain natriuretic peptide levels [ Time Frame: one hour and three hours after administration of fluid resuscitation ] [ Designated as safety issue: Yes ]
  • Plasma osmolarity [ Time Frame: one hour and three hours after administration of fluid resuscitation ] [ Designated as safety issue: Yes ]
  • Oncotic pressure [ Time Frame: one hour and three hours after administration of fluid resuscitation ] [ Designated as safety issue: Yes ]
  • Electrical impedance tomography [ Time Frame: one hour and three hours after administration of fluid resuscitation ] [ Designated as safety issue: Yes ]
  • Mortality [ Time Frame: Day 20, Day 90 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
hydroxyethyl starch
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 hydroxyethyl starch and those treated with crystalloid (fluid challenge of 7 mL/kg over 15 minutes, that can be repeated 3 times if hypovolemia persists).
Drug: hydroxyethyl starch
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 hydroxyethyl starch and those treated with crystalloid (fluid challenge of 7 mL/kg over 15 minutes, that can be repeated 3 times if hypovolemia persists).
Drug: hydroxyethyl starch

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 hydroxyethyl starch 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 hydroxyethyl starch 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Diseases) - EA7281, Universite d’Auvergne Clermont 1, Clermont-Ferrand
Investigators
Principal Investigator: Matthieu JABAUDON University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01763853     History of Changes
Other Study ID Numbers: CHU-0134
Study First Received: December 10, 2012
Last Updated: January 7, 2013
Health Authority: France: Ministry of Health

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:
Edema
Pulmonary Edema
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Hypovolemia
Signs and Symptoms
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Pathologic Processes
Hetastarch
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014