Effects of Different Crystalloid Solutions for Extra-corp... | NCT02609360

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

NCT02609360

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Status

Unknown status

Last Update Posted

Nov 20, 2015Estimated

Enrollment

45Estimated

Phase

Not Applicable

Conditions

Acute Respiratory Failure

Interventions

Priming of ECMO circuit with 0.9% NaCl
Priming of ECMO circuit with Ringer Lactate
Priming of ECMO circuit with Balanced Solution

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013

Primary Completion Date

Jul 2016Estimated

Completion Date

Not provided

First Submitted Date

Nov 7, 2015

First Submission Date that Met QC Criteria

Nov 17, 2015

First Posted Date

Nov 20, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2015

Last Update Posted Date

Nov 20, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Priming of ECMO circuit with 0.9% NaCl	Other	0.9% NaCl as priming crystalloid solution	0.9% NaCl

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with Acute Respiratory Failure in need for ECMO treatment

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Pietro Caironi, MD	Contact	+39-02-55033232		pietro.caironi@unimi.it

Overall Officials

Name	Affiliation	Role
Pietro Caironi, MD	Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico	Recruiting	Milan		20122	Italy

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations