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

NCT ID: NCT02609360

Last Updated: 2015-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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0.9% NaCl

Circuit priming will be performed with 0.9% NaCl solution

Group Type ACTIVE_COMPARATOR

Priming of ECMO circuit with 0.9% NaCl

Intervention Type OTHER

0.9% NaCl as priming crystalloid solution

Ringer Lactate

Circuit priming will be performed with Ringer Lactated

Group Type ACTIVE_COMPARATOR

Priming of ECMO circuit with Ringer Lactate

Intervention Type OTHER

Ringer Lactate as priming crystalloid solution

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.

Group Type EXPERIMENTAL

Priming of ECMO circuit with Balanced Solution

Intervention Type OTHER

Balanced Solution as priming crystalloid solution

Interventions

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Priming of ECMO circuit with 0.9% NaCl

0.9% NaCl as priming crystalloid solution

Intervention Type OTHER

Priming of ECMO circuit with Ringer Lactate

Ringer Lactate as priming crystalloid solution

Intervention Type OTHER

Priming of ECMO circuit with Balanced Solution

Balanced Solution as priming crystalloid solution

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with Acute Respiratory Failure in need for ECMO treatment

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pietro Caironi, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Locations

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Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Pietro Caironi, MD

Role: CONTACT

[email protected]
+39-02-55033232

Facility Contacts

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Pietro Caironi, MD

Role: primary

[email protected]
+39-02-55033232

Other Identifiers

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1897

Identifier Type: -

Identifier Source: org_study_id