Metabolic AcidosisNCT02800343
Intraoperative Cell Salvage and Postoperative Acidosis
An observational study of Metabolic Acidosis, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
Metabolic acidosis is a common complication that patients experience in the early postoperative period following cardiac surgery. Increasingly, the composition and volume of intravenous fluids administered during surgery have been implicated in the development of postoperative acidosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Acidosis
- What is being tested?
- routine administration of 0.9% sodium chloride
- Type of treatment
- Surgery or procedure
- How many people
- 37 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Jul 2016to 31 Jul 2016
- Phase
- Observational
- 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
Study population: All adult patients undergoing elective or emergency cardiovascular surgery at the study site (Royal Infirmary of Edinburgh) during the data collection phase of the project will be approached for consent.
Who may be able to join
- Age ≥ 18 years
- Patients scheduled for cardiac surgery including both on- and off-pump coronary artery bypass grafting surgery, heart valve surgery, septal surgery, and aortic surgery)
- Patients must have consented to participate
Who cannot join
- Patients under 18 years of age
- Patients who are unable or unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Infirmary of Edinburgh
Edinburgh, Midlothian, EH16 4SA
About this study
Official title: The Contribution of Intraoperative Mechanical Red Cell Salvage to Acidosis in the Immediate Postoperative Period After Cardiac Surgery
Metabolic acidosis is a common complication that patients experience in the early postoperative period following cardiac surgery. Increasingly, the composition and volume of intravenous fluids administered during surgery have been implicated in the development of postoperative acidosis. Intraoperative Cell Salvage (ICS), an autologous blood transfusion technique employed by Cardiac/Perfusion Units to minimize blood loss during surgery, involves the infusion of of one such fluid, 0.9% sodium chloride. The rapid infusion of large volumes of 0.9% sodium chloride has previously been linked with the development of hyperchloraemic acidosis. It was therefore hypothesized that the volume of mechanically salvaged of red blood cells re-infused into patients undergoing heart surgery contributes to the acidosis that occurs in the early postoperative period.
To test this, the investigators have designed an observational cohort study to check for correlation between the volume of cell salvaged blood infused during surgery and the severity of postoperative acidosis (which will be assessed using data from routine arterial blood gas samples).
- Conditions
- Metabolic Acidosis
- Being tested
- routine administration of 0.9% sodium chloride
- Medical subject headings
- Acidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
routine administration of 0.9% sodium chlorideProcedure or surgery
Also called Baxter 0.9% sodium chloride
0.9% sodium chloride is used as the wash and suspension solution for red blood cells during the Intraoperative red blood cell salvage (ICS) procedure.
| Study group | Role | What they receive |
|---|---|---|
| Cardiovascular surgery | All adult patients undergoing elective or emergency cardiovascular surgery at the study site Receives: Procedure: routine administration of 0.9% sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma hydrogen ion concentration
Plasma hydrogen ion concentration is measured by the arterial blood gas analyzer machine, and serves as a direct indicator of plasma acidity at a given time point.
Data from two routine blood gas samples are of interest:
T1 - baseline measurement taken on insertion of an arterial line immediately after the induction of anaesthesia (i.e. before any fluid infusion has commenced); T2 - postoperative measurement made immediately after patient arrives in ICU (i.e. once all the cell salvaged blood has been transfused)
Measured: at the start of surgery (before fluid infusion) and immediately after surgery (after fluid infusion)
Secondary outcomes (2)
plasma chloride concentration
Plasma chloride concentration is measured by the arterial blood gas analyzer machine.
Data from two routine blood gas samples are of interest:
T1 - baseline measurement taken on insertion of an arterial line immediately after the induction of anaesthesia (i.e. before any fluid infusion has commenced); T2 - postoperative measurement made immediately after patient arrives in ICU (i.e. once all the cell salvaged blood has been transfused)
Measured: at the start of surgery (before fluid infusion) and immediately after surgery (after fluid infusion)
plasma strong ion difference
Plasma strong ion difference can be computed from routine arterial blood gas electrolyte measurements (chloride, lactate, sodium, potassium) using a formula.
Strong ion difference serves as an indirect measure of plasma acidity.
Data from two routine blood gas samples are of interest:
T1 - baseline measurement taken on insertion of an arterial line immediately after the induction of anaesthesia (i.e. before any fluid infusion has commenced); T2 - postoperative measurement made immediately after patient arrives in ICU (i.e. once all the cell salvaged blood has been transfused)
Measured: at the start of surgery (before fluid infusion) and immediately after surgery (after fluid infusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study start8 Jul 2016
- Primary completion31 Jul 2016
- Study completion31 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic AcidosisStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Sponsor
- Investigators
- Peter R Alston, MBChB, FRCA, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800343
- Sponsor's protocol ID
- AC16077
- Status last verified
- May 2024
- First submitted
- 10 Jun 2016
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The findings of the study will be written up as a scientific report, which will be submitted for publication in a peer-reviewed scientific journal and presented at a conference. At the time of publication/dissemination, individual participant data will be reported as an aggregate.
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Contribution of Intraoperative Mechanical Red Cell Salvage to Acidosis in the Immediate Postoperative Period After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02800343
- Acronym / sponsor ID
- AC16077
- Conditions
- Metabolic Acidosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- 8 Jul 2016 (actual)
- Primary completion
- 31 Jul 2016 (actual)
- Study completion
- 31 Jul 2016 (actual)
- First posted
- 15 Jun 2016 (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.
Metabolic acidosis is a common complication that patients experience in the early postoperative period following cardiac surgery. Increasingly, the composition and volume of intravenous fluids administered during surgery have been implicated in the development of postoperative acidosis. Intraoperative Cell Salvage (ICS), an autologous blood transfusion technique employed by Cardiac/Perfusion Units to minimize blood loss during surgery, involves the infusion of of one such fluid, 0.9% sodium chloride. The rapid infusion of large volumes of 0.9% sodium chloride has previously been linked with the development of hyperchloraemic acidosis. It was therefore hypothesized that the volume of mechanically salvaged of red blood cells re-infused into patients undergoing heart surgery contributes to the acidosis that occurs in the early postoperative period.
To test this, the investigators have designed an observational cohort study to check for correlation between the volume of cell salvaged blood infused during surgery and the severity of postoperative acidosis (which will be assessed using data from routine arterial blood gas samples).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiovascular surgery | – | Procedure: routine administration of 0.9% sodium chlorideAll adult patients undergoing elective or emergency cardiovascular surgery at the study site |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients undergoing elective or emergency cardiovascular surgery at the study site (Royal Infirmary of Edinburgh) during the data collection phase of the project will be approached for consent.
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Patients scheduled for cardiac surgery including both on- and off-pump coronary artery bypass grafting surgery, heart valve surgery, septal surgery, and aortic surgery)
- Patients must have consented to participate
Key exclusion criteria (2 listed)
- Patients under 18 years of age
- Patients who are unable or unwilling to provide informed consent
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 |
|---|---|---|
| routine administration of 0.9% sodium chlorideAlso: Baxter 0.9% sodium chloride0.9% sodium chloride is used as the wash and suspension solution for red blood cells during the Intraoperative red blood cell salvage (ICS) procedure. | Procedure or surgery | Cardiovascular surgery |
Primary outcome
plasma hydrogen ion concentration
Time frame: at the start of surgery (before fluid infusion) and immediately after surgery (after fluid infusion)
Plasma hydrogen ion concentration is measured by the arterial blood gas analyzer machine, and serves as a direct indicator of plasma acidity at a given time point. Data from two routine blood gas samples are of interest: T1 - baseline measurement taken on insertion of an arterial line immediately after the induction of anaesthesia (i.e. before any fluid infusion has commenced); T2 - postoperative measurement made immediately after patient arrives in ICU (i.e. once all the cell salvaged blood has been transfused)
2 secondary outcomes
plasma chloride concentration
Time frame: at the start of surgery (before fluid infusion) and immediately after surgery (after fluid infusion)
plasma strong ion difference
Time frame: at the start of surgery (before fluid infusion) and immediately after surgery (after fluid infusion)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: Yes. The findings of the study will be written up as a scientific report, which will be submitted for publication in a peer-reviewed scientific journal and presented at a conference. At the time of publication/dissemination, individual participant data will be reported as an aggregate.
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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.
Peter R Alston, MBChB, FRCA principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Acidosis, run by University of Edinburgh at 1 site in United Kingdom.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 17 May 2024. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma hydrogen ion concentration (time frame: at the start of surgery (before fluid infusion) and immediately after surgery (after fluid infusion)). 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 17 May 2024.