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

NCT01763853 | Unknown Phase 4

• 1 other identifier: CHU-0134
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Rate of alveolar fluid clearance

  one hour after administration of fluid resuscitation

Secondary Outcomes (20)

• Extra-vascular lung water

  one hour and three hours after administration of fluid resuscitation

• Pulmonary vascular permeability index

  one hour and three hours after administration of fluid resuscitation

• Global enddiastolic volume index

  one hour and three hours after administration of fluid resuscitation

• mean arterial pressure

  one hour and three hours after administration of fluid resuscitation

• cardiac output

  one hour and three hours after administration of fluid resuscitation

Study Arms (2)

albumin

OTHER

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

OTHER

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

Interventions

4% albumin DRUG

albumin; crystalloid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• R2D2 Retinoids, Reproduction Developmental Diseases: collaborator
• Université d'Auvergne: collaborator

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome; Hypovolemia; Pulmonary Edema

Interventions

Albumins

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Matthieu JABAUDON

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95; placarin@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2012
• First Posted: January 9, 2013
• Study Start: December 1, 2012
• Primary Completion: April 1, 2017
• Study Completion: May 1, 2017
• Last Updated: July 29, 2016

Record last verified: 2016-07

Locations

FR (1)