Acute Respiratory FailureNCT02609360
Effects of Different Crystalloid Solutions for Extra-corporeal Membrane Oxygenator (ECMO) Priming
A study testing Priming of ECMO circuit with 0.9% NaCl, Priming of ECMO circuit with Ringer Lactate and Priming of ECMO circuit with Balanced Solution in people with Acute Respiratory Failure, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- Priming of ECMO circuit with 0.9% NaCl, Priming of ECMO circuit with Ringer Lactate and Priming of ECMO circuit with Balanced Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- May 2013to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Acute Respiratory Failure in need for ECMO treatment
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
Milan, 20122
Pietro Caironi, MD, +39-02-55033232, pietro.caironi@unimi.it
About this study
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.
- Conditions
- Acute Respiratory Failure
- Being tested
- Priming of ECMO circuit with 0.9% NaCl, Priming of ECMO circuit with Ringer Lactate, Priming of ECMO circuit with Balanced Solution
- Keywords
- Acute Respiratory Failure, ARDS, ECMO, Lung transplantation, Acid-Base Equilibrium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Priming of ECMO circuit with 0.9% NaClOther
0.9% NaCl as priming crystalloid solution
Priming of ECMO circuit with Ringer LactateOther
Ringer Lactate as priming crystalloid solution
Priming of ECMO circuit with Balanced SolutionOther
Balanced Solution as priming crystalloid solution
| Study group | Role | What they receive |
|---|---|---|
| 0.9% NaCl | Active comparator | Circuit priming will be performed with 0.9% NaCl solution Receives: Other: Priming of ECMO circuit with 0.9% NaCl |
| Ringer Lactate | Active comparator | Circuit priming will be performed with Ringer Lactated Receives: 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. Receives: Other: Priming of ECMO circuit with Balanced Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in Acid-Base Equilibrium (Base Excess)
Measured: First 24 hours after ECMO start
Secondary outcomes (2)
Variation in Acid-Base Equilibrium (pH)
Measured: First 24 hours after ECMO start
Variation in Renal Function
Measured: First 24 hours after ECMO start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startMay 2013
- Primary completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pietro Caironi, MD, Principal investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609360
- Sponsor's protocol ID
- 1897
- Status last verified
- Nov 2015
- First submitted
- 7 Nov 2015
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Crystalloid Solutions for Extra-corporeal Membrane Oxygenator (ECMO) Priming
- ClinicalTrials.gov ID
- NCT02609360
- Acronym / sponsor ID
- 1897
- Conditions
- Acute Respiratory Failure
- Keywords
- Acute Respiratory Failure, ARDS, ECMO, Lung transplantation, Acid-Base Equilibrium
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jul 2016 (estimated)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.9% NaCl | Active comparator | Other: Priming of ECMO circuit with 0.9% NaClCircuit priming will be performed with 0.9% NaCl solution |
| Ringer Lactate | Active comparator | Other: Priming of ECMO circuit with Ringer LactateCircuit priming will be performed with Ringer Lactated |
| Balanced Solution | Experimental | Other: Priming of ECMO circuit with Balanced SolutionCircuit 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with Acute Respiratory Failure in need for ECMO treatment
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Priming of ECMO circuit with 0.9% NaCl0.9% NaCl as priming crystalloid solution | Other | 0.9% NaCl |
| Priming of ECMO circuit with Ringer LactateRinger Lactate as priming crystalloid solution | Other | Ringer Lactate |
| Priming of ECMO circuit with Balanced SolutionBalanced Solution as priming crystalloid solution | Other | Balanced Solution |
Primary outcome
Variation in Acid-Base Equilibrium (Base Excess)
Time frame: First 24 hours after ECMO start
2 secondary outcomes
Variation in Acid-Base Equilibrium (pH)
Time frame: First 24 hours after ECMO start
Variation in Renal Function
Time frame: First 24 hours after ECMO start
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pietro Caironi, MD principal investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Priming of ECMO circuit with 0.9% NaCl, Priming of ECMO circuit with Ringer Lactate and Priming of ECMO circuit with Balanced Solution in people with Acute Respiratory Failure, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pietro Caironi, MD (+39-02-55033232, pietro.caironi@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation in Acid-Base Equilibrium (Base Excess) (time frame: First 24 hours after ECMO start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015.