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

NCT02609360 | Unknown

• 1 other identifier: 1897
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Failure

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Variation in Acid-Base Equilibrium (Base Excess)

  First 24 hours after ECMO start

Secondary Outcomes (2)

• Variation in Acid-Base Equilibrium (pH)

  First 24 hours after ECMO start

• Variation in Renal Function

  First 24 hours after ECMO start

Study Arms (3)

0.9% NaCl

ACTIVE COMPARATOR

Circuit priming will be performed with 0.9% NaCl solution

Other: Priming of ECMO circuit with 0.9% NaCl

Ringer Lactate

ACTIVE COMPARATOR

Circuit priming will be performed with Ringer Lactated

Other: Priming of ECMO circuit with Ringer Lactate

Balanced Solution

EXPERIMENTAL

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

Priming of ECMO circuit with 0.9% NaCl OTHER

0.9% NaCl as priming crystalloid solution

0.9% NaCl

Priming of ECMO circuit with Ringer Lactate OTHER

Ringer Lactate as priming crystalloid solution

Ringer Lactate

Priming of ECMO circuit with Balanced Solution OTHER

Balanced Solution as priming crystalloid solution

Balanced Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Acute Respiratory Failure in need for ECMO treatment

You may not qualify if:

• None

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

Milan, 20122, Italy

RECRUITING

MeSH Terms

Interventions

Ringer's Lactate

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Pietro Caironi, MD

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pietro Caironi, MD

CONTACT

+39-02-55033232; pietro.caironi@unimi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2015
• First Posted: November 20, 2015
• Study Start: May 1, 2013
• Primary Completion: July 1, 2016
• Last Updated: November 20, 2015

Record last verified: 2015-11

Locations

IT (1)