Intraoperative Cell Salvage and Postoperative Acidosis

NCT02800343 | Completed

• 1 other identifier: AC16077
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

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. 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• plasma chloride concentration

  at the start of surgery (before fluid infusion) and immediately after surgery (after fluid infusion)

• plasma strong ion difference

  at the start of surgery (before fluid infusion) and immediately after surgery (after fluid infusion)

Study Arms (1)

Cardiovascular surgery

All adult patients undergoing elective or emergency cardiovascular surgery at the study site

Procedure: routine administration of 0.9% sodium chloride

Interventions

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.

Also known as: Baxter 0.9% sodium chloride

Cardiovascular surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, Midlothian, EH16 4SA, United Kingdom

Location

MeSH Terms

Conditions

Acidosis

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Peter R Alston, MBChB, FRCA

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2016
• First Posted: June 15, 2016
• Study Start: July 8, 2016
• Primary Completion: July 31, 2016
• Study Completion: July 31, 2016
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)