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

November 17, 2015 updated by: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Milan, Italy, 20122
        • Recruiting
        • Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with Acute Respiratory Failure in need for ECMO treatment

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Variation in Acid-Base Equilibrium (Base Excess)
Time Frame: First 24 hours after ECMO start
First 24 hours after ECMO start

Secondary Outcome Measures

Outcome Measure
Time Frame
Variation in Acid-Base Equilibrium (pH)
Time Frame: First 24 hours after ECMO start
First 24 hours after ECMO start
Variation in Renal Function
Time Frame: First 24 hours after ECMO start
First 24 hours after ECMO start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (ANTICIPATED)

July 1, 2016

Study Registration Dates

First Submitted

November 7, 2015

First Submitted That Met QC Criteria

November 17, 2015

First Posted (ESTIMATE)

November 20, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

November 20, 2015

Last Update Submitted That Met QC Criteria

November 17, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1897

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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