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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Respiratory Failure

Intervention / Treatment
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* Other: Priming of ECMO circuit with 0.9% NaCl
* Other: Priming of ECMO circuit with Ringer Lactate
* Other: Priming of ECMO circuit with Balanced Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Acute Respiratory Failure in need for ECMO treatment Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 0.9% NaCl<br>Circuit priming will be performed with 0.9% NaCl solution | Other: Priming of ECMO circuit with 0.9% NaCl<br>* 0.9% NaCl as priming crystalloid solution<br>|
| Active Comparator: Ringer Lactate<br>Circuit priming will be performed with Ringer Lactated | Other: Priming of ECMO circuit with Ringer Lactate<br>* Ringer Lactate as priming crystalloid solution<br>|
| Experimental: Balanced Solution<br>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<br>* Balanced Solution as priming crystalloid solution<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Respiratory Failure, ARDS, ECMO, Lung transplantation, Acid-Base Equilibrium