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

Hypovolemia Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01763853
• Other study ID #: CHU-0134
• Status: Recruiting
• Phase: Phase 4
• First received: December 10, 2012
• Last updated: July 28, 2016
• Start date: December 2012
• Est. completion date: May 2017

Study information

• Verified date: July 2016
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: May 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome (ARDS)
• Edema
• Hypovolemia
• Pulmonary Edema
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Drug:
• 4% albumin

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	R2D2 Retinoids, Reproduction Developmental Diseases, Université d'Auvergne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of alveolar fluid clearance		one hour after administration of fluid resuscitation	Yes
Secondary	Extra-vascular lung water		one hour and three hours after administration of fluid resuscitation	Yes
Secondary	Pulmonary vascular permeability index		one hour and three hours after administration of fluid resuscitation	Yes
Secondary	Global enddiastolic volume index		one hour and three hours after administration of fluid resuscitation	Yes
Secondary	mean arterial pressure		one hour and three hours after administration of fluid resuscitation	Yes
Secondary	cardiac output		one hour and three hours after administration of fluid resuscitation	Yes
Secondary	pulse pressure variation		one hour and three hours after administration of fluid resuscitation	Yes
Secondary	stroke volume variation		one hour and three hours after administration of fluid resuscitation	Yes
Secondary	central venous venous oxygenation		one hour and three hours after administration of fluid resuscitation	Yes
Secondary	central venous pressure		one hour and three hours after administration of fluid resuscitation	Yes
Secondary	PaO2		one hour and three hours after administration of fluid resuscitation	Yes
Secondary	lung compliance		one hour and three hours after administration of fluid resuscitation	Yes
Secondary	airways resistance		one hour and three hours after administration of fluid resuscitation	Yes
Secondary	lung injury score		one hour and three hours after administration of fluid resuscitation	Yes
Secondary	Plasma levels of sRAGE		one hour and three hours after administration of fluid resuscitation	Yes
Secondary	Alveolar levels of sRAGE		one hour and three hours after administration of fluid resuscitation	Yes
Secondary	Brain natriuretic peptide levels		one hour and three hours after administration of fluid resuscitation	Yes
Secondary	Plasma osmolarity		one hour and three hours after administration of fluid resuscitation	Yes
Secondary	Oncotic pressure		one hour and three hours after administration of fluid resuscitation	Yes
Secondary	Electrical impedance tomography		one hour and three hours after administration of fluid resuscitation	Yes
Secondary	Mortality		Day 20, Day 90	Yes