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NCT Number: NCT02800343

Intraoperative Cell Salvage and Postoperative Acidosis

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).

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Key information

Conditions

Metabolic Acidosis Acid-Base Imbalance Acidosis Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Infirmary of Edinburgh

Edinburgh, Midlothian, EH16 4SA, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

routine administration of 0.9% sodium chloride

Procedure

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 names: Baxter 0.9% sodium chloride

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • NHS Lothian

Registry information

Official study title

The Contribution of Intraoperative Mechanical Red Cell Salvage to Acidosis in the Immediate Postoperative Period After Cardiac Surgery

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 15, 2016
Registry last updated
May 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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