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

Primary Purpose

Acute Respiratory Failure

Status

Unknown status

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Priming of ECMO circuit with 0.9% NaCl

Priming of ECMO circuit with Ringer Lactate

Priming of ECMO circuit with Balanced Solution

About this trial

This is an interventional basic science trial for Acute Respiratory Failure focused on measuring Acute Respiratory Failure, ARDS, ECMO, Lung transplantation, Acid-Base Equilibrium

Eligibility Criteria

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

Inclusion Criteria:

Patients with Acute Respiratory Failure in need for ECMO treatment

Exclusion Criteria:

None

Sites / Locations

Fondazione IRCCS Ca' Granda - Ospedale Maggiore PoliclinicoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

0.9% NaCl

Ringer Lactate

Balanced Solution

Arm Description

Circuit priming will be performed with 0.9% NaCl solution

Circuit priming will be performed with Ringer Lactated

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.

Outcomes

Primary Outcome Measures

Variation in Acid-Base Equilibrium (Base Excess)

Secondary Outcome Measures

Variation in Acid-Base Equilibrium (pH)

Variation in Renal Function

Full Information

NCT ID

NCT02609360

First Posted

November 7, 2015

Last Updated

November 17, 2015

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

1. Study Identification

Unique Protocol Identification Number

NCT02609360

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Unknown status

Study Start Date

May 2013 (undefined)

Primary Completion Date

July 2016 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

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

Acute Respiratory Failure

Keywords

Acute Respiratory Failure, ARDS, ECMO, Lung transplantation, Acid-Base Equilibrium

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

0.9% NaCl

Arm Type

Active Comparator

Arm Description

Circuit priming will be performed with 0.9% NaCl solution

Arm Title

Ringer Lactate

Arm Type

Active Comparator

Arm Description

Circuit priming will be performed with Ringer Lactated

Arm Title

Balanced Solution

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Priming of ECMO circuit with 0.9% NaCl

Intervention Description

0.9% NaCl as priming crystalloid solution

Intervention Type

Other

Intervention Name(s)

Priming of ECMO circuit with Ringer Lactate

Intervention Description

Ringer Lactate as priming crystalloid solution

Intervention Type

Other

Intervention Name(s)

Priming of ECMO circuit with Balanced Solution

Intervention Description

Balanced Solution as priming crystalloid solution

Primary Outcome Measure Information:

Title

Variation in Acid-Base Equilibrium (Base Excess)

Time Frame

First 24 hours after ECMO start

Secondary Outcome Measure Information:

Title

Variation in Acid-Base Equilibrium (pH)

Time Frame

First 24 hours after ECMO start

Title

Variation in Renal Function

Time Frame

First 24 hours after ECMO start

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with Acute Respiratory Failure in need for ECMO treatment Exclusion Criteria: None

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pietro Caironi, MD

Phone

+39-02-55033232

pietro.caironi@unimi.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pietro Caironi, MD

Organizational Affiliation

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

City

Milan

ZIP/Postal Code

20122

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pietro Caironi, MD

Phone

+39-02-55033232

pietro.caironi@unimi.it

12. IPD Sharing Statement

Learn more about this trial

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

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