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NCT02609360 Clinical Trial

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

Acute Respiratory Failure Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02609360
Other study ID # 1897
Secondary ID
Status Recruiting
Phase N/A
First received November 7, 2015
Last updated November 17, 2015
Start date May 2013

Study information
Verified date November 2015
Source Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Contact Pietro Caironi, MD
Phone +39-02-55033232
Email pietro.caironi@unimi.it
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 45
Est. completion date
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with Acute Respiratory Failure in need for ECMO treatment

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Other:
• Priming of ECMO circuit with 0.9% NaCl
0.9% NaCl as priming crystalloid solution
• Priming of ECMO circuit with Ringer Lactate
Ringer Lactate as priming crystalloid solution
• Priming of ECMO circuit with Balanced Solution
Balanced Solution as priming crystalloid solution

Locations
Country Name City State
Italy Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico Milan

Sponsors (1)
Lead Sponsor Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Variation in Acid-Base Equilibrium (Base Excess) First 24 hours after ECMO start No
Secondary Variation in Acid-Base Equilibrium (pH) First 24 hours after ECMO start No
Secondary Variation in Renal Function First 24 hours after ECMO start No
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