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Effects of Different Crystalloid Solutions for Extra-corporeal Membrane Oxygenator (ECMO) Priming

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02609360
Recruitment Status : Unknown
Verified November 2015 by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico.
Recruitment status was:  Recruiting
First Posted : November 20, 2015
Last Update Posted : November 20, 2015
Sponsor:
Information provided by (Responsible Party):
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Brief Summary:
Crystalloid solutions modify acid-base equilibrium according to their electrolyte composition. Moreover, it has been suggested that these alterations are generated by the difference between the solution strong ion difference (SID) and the plasma bicarbonate level. An increased risk of acute kidney injury and renal replacement therapy has been associated to the infusion of chloride rich crystalloids. This study aims to compare, in patients with acute respiratory failure undergoing ECMO support, the effects on acid-base status and renal function of crystalloids commonly employed for circuit priming to a balanced solution created with a SID equal to patients' bicarbonate level.

Condition or disease Intervention/treatment Phase
Acute Respiratory Failure Other: Priming of ECMO circuit with 0.9% NaCl Other: Priming of ECMO circuit with Ringer Lactate Other: Priming of ECMO circuit with Balanced Solution Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Different Crystalloid Solutions for Extra-corporeal Membrane Oxygenator (ECMO) Priming
Study Start Date : May 2013
Estimated Primary Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 0.9% NaCl
Circuit priming will be performed with 0.9% NaCl solution
Other: Priming of ECMO circuit with 0.9% NaCl
0.9% NaCl as priming crystalloid solution

Active Comparator: Ringer Lactate
Circuit priming will be performed with Ringer Lactated
Other: Priming of ECMO circuit with Ringer Lactate
Ringer Lactate as priming crystalloid solution

Experimental: Balanced Solution
Circuit priming will be performed with a Balanced Solution created by mixing 0.9% NaCl, Sodium bicarbonate (8.4%) and injectable sterile water, in order to obtain a solution with constant sodium concentration (140 mEq/l) and SID equal to patient's bicarbonate level.
Other: Priming of ECMO circuit with Balanced Solution
Balanced Solution as priming crystalloid solution




Primary Outcome Measures :
  1. Variation in Acid-Base Equilibrium (Base Excess) [ Time Frame: First 24 hours after ECMO start ]

Secondary Outcome Measures :
  1. Variation in Acid-Base Equilibrium (pH) [ Time Frame: First 24 hours after ECMO start ]
  2. Variation in Renal Function [ Time Frame: First 24 hours after ECMO start ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients with Acute Respiratory Failure in need for ECMO treatment

Exclusion Criteria:

  • None

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): NCT02609360


Contacts
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Contact: Pietro Caironi, MD +39-02-55033232 pietro.caironi@unimi.it

Locations
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Italy
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico Recruiting
Milan, Italy, 20122
Contact: Pietro Caironi, MD    +39-02-55033232    pietro.caironi@unimi.it   
Sponsors and Collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Investigators
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Principal Investigator: Pietro Caironi, MD Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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Responsible Party: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier: NCT02609360    
Other Study ID Numbers: 1897
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015
Keywords provided by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:
Acute Respiratory Failure
ARDS
ECMO
Lung transplantation
Acid-Base Equilibrium
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Pharmaceutical Solutions