Intraoperative Cell Salvage and Postoperative Acidosis

Metabolic Acidosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02800343
• Other study ID #: AC16077
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Acidosis
• Metabolic Acidosis

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)