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Intraoperative Cell Salvage and Postoperative Acidosis

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ClinicalTrials.gov Identifier: NCT02800343
Recruitment Status : Unknown
Verified June 2016 by University of Edinburgh.
Recruitment status was:  Not yet recruiting
First Posted : June 15, 2016
Last Update Posted : June 15, 2016
Sponsor:
Collaborator:
NHS Lothian
Information provided by (Responsible Party):
University of Edinburgh

Brief 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. 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. We hypothesize 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, we 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).


Condition or disease Intervention/treatment
Metabolic Acidosis Procedure: routine administration of 0.9% sodium chloride

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Contribution of Intraoperative Mechanical Red Cell Salvage to Acidosis in the Immediate Postoperative Period After Cardiac Surgery
Study Start Date : July 2016
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Cardiovascular surgery
All adult patients undergoing elective or emergency cardiovascular surgery at the study site
Procedure: routine administration of 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.
Other Name: Baxter 0.9% sodium chloride




Primary Outcome Measures :
  1. 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)



Secondary Outcome Measures :
  1. plasma chloride concentration [ Time Frame: at the start of surgery (before fluid infusion) and immediately after surgery (after fluid infusion) ]

    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)


  2. plasma strong ion difference [ Time Frame: at the start of surgery (before fluid infusion) and immediately after surgery (after fluid infusion) ]

    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)




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients under 18 years of age
  • Patients who are unable or unwilling to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02800343


Contacts
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Contact: Peter R Alston, MBChB, FRCA +44 131 242 3180 peter.alston@ed.ac.uk
Contact: Maithili M Mehta, BSc (Hons) +44 7341576937 s1003484@sms.ed.ac.uk

Locations
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United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, Midlothian, United Kingdom, EH16 4SA
Contact: Peter R Alston, MBChB, FRCA    +44 131 242 3180    peter.alston@ed.ac.uk   
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
Investigators
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Principal Investigator: Peter R Alston, MBChB, FRCA University of Edinburgh
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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT02800343    
Other Study ID Numbers: AC16077
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: June 15, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.

Additional relevant MeSH terms:
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Acidosis
Acid-Base Imbalance
Metabolic Diseases