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

Not Applicable

• Conditions: Acute Respiratory Failure
• Interventions: Other: Priming of ECMO circuit with 0.9% NaCl; Other: Priming of ECMO circuit with Balanced Solution; Other: Priming of ECMO circuit with Ringer Lactate

• Registration Number: NCT02609360
• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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 available

Study Timeline

• Study Start: 2013-05
• Status Verified: 2015-11
• Study First Submitted: 2015-11-07
• Study First Submitted QC: 2015-11-17
• Last Update Submitted: 2015-11-17
• Study First Posted: 2015-11-20
• Last Update Posted: 2015-11-20
• Primary Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Patients with Acute Respiratory Failure in need for ECMO treatment

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.9% NaCl	Priming of ECMO circuit with 0.9% NaCl	Circuit priming will be performed with 0.9% NaCl solution
Balanced Solution	Priming of ECMO circuit with 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.
Ringer Lactate	Priming of ECMO circuit with Ringer Lactate	Circuit priming will be performed with Ringer Lactated

Primary Outcome Measures

Name	Time	Method
Variation in Acid-Base Equilibrium (Base Excess)	First 24 hours after ECMO start

Secondary Outcome Measures

Name	Time	Method
Variation in Renal Function	First 24 hours after ECMO start
Variation in Acid-Base Equilibrium (pH)	First 24 hours after ECMO start

Trial Locations

Locations (1)

Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico; 🇮🇹 Milan, Italy