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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Unknown

Conditions: Acute Respiratory Failure

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT02609360

1897

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with Acute Respiratory Failure in need for ECMO treatment

Exclusion criteria

• None

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

0.9% NaCl

Active Comparator group

Description:

Circuit priming will be performed with 0.9% NaCl solution

Treatment:

Other: Priming of ECMO circuit with 0.9% NaCl

Ringer Lactate

Active Comparator group

Description:

Circuit priming will be performed with Ringer Lactated

Treatment:

Other: Priming of ECMO circuit with Ringer Lactate

Balanced Solution

Experimental group

Description:

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.

Treatment:

Other: Priming of ECMO circuit with Balanced Solution