CClinicalTrials.gg
Status unknownNCT02609360Updated Nov 20, 2015

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

An interventional study of Priming of ECMO circuit with 0.9% NaCl and Priming of ECMO circuit with Ringer Lactate in Acute Respiratory Failure, sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-11-20.

Sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Nov 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Respiratory Failure

Keywords

  • Acute Respiratory Failure
  • ARDS
  • ECMO
  • Lung transplantation
  • Acid-Base Equilibrium
03

In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's planned enrollment of 45 is below the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico is the lead sponsor of 214 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with Acute Respiratory Failure in need for ECMO treatment

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
45 participants (estimated)

Study arms

  • Active comparator
    0.9% NaCl

    Circuit priming will be performed with 0.9% NaCl solution

    Other: Priming of ECMO circuit with 0.9% NaCl

  • Active comparator
    Ringer Lactate

    Circuit priming will be performed with Ringer Lactated

    Other: Priming of ECMO circuit with Ringer Lactate

  • 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

Interventions

  • OtherPriming of ECMO circuit with 0.9% NaCl

    0.9% NaCl as priming crystalloid solution

  • OtherPriming of ECMO circuit with Ringer Lactate

    Ringer Lactate as priming crystalloid solution

  • OtherPriming of ECMO circuit with Balanced Solution

    Balanced Solution as priming crystalloid solution

06

What researchers measure

Primary outcomes

  1. Variation in Acid-Base Equilibrium (Base Excess)

    Time frame: First 24 hours after ECMO start

Secondary outcomes

  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

07

Study locations

1 of 1 sites recruiting
  • Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
    Milan, 20122, Italy
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02609360
Lead sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Responsible party
Sponsor
First posted
Nov 20, 2015
Start date
May 2013
Primary completion
Jul 2016 (estimated)
Last update
Nov 20, 2015

Study contacts

Pietro Caironi, MD
Contact
pietro.caironi@unimi.it
+39-02-55033232
Pietro Caironi, MD
principal investigator · Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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