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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02800343
Other study ID # AC16077
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 8, 2016
Est. completion date July 31, 2016

Study information

Verified date May 2024
Source University of Edinburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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).


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date July 31, 2016
Est. primary completion date July 31, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United Kingdom Royal Infirmary of Edinburgh Edinburgh Midlothian

Sponsors (2)

Lead Sponsor Collaborator
University of Edinburgh NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
at the start of surgery (before fluid infusion) and immediately after surgery (after fluid infusion)
Secondary 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)
at the start of surgery (before fluid infusion) and immediately after surgery (after fluid infusion)
Secondary 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)
at the start of surgery (before fluid infusion) and immediately after surgery (after fluid infusion)
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