Lactate in High-risk Cardiac Surgery

NCT02568969 | Completed

• 1 other identifier: LAC-1
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The major combined interventions are between challenging and high-risk aspects of current cardiosurgical practice. The results of operation may be hampered by unexpected anatomic and technical features influencing the surgical approach as well as cardiopulmonary bypass (CPB), anesthesia, and respiratory support. Plasma lactate concentration is a routine clinical indicator of the tissue oxygen shortage, and is routinely monitored in virtually all in-risk surgical and ICU patients. However, the discrete measurement of these values among with other biochemical values has a major drawback and continuous measurement can be beneficial. The aim of our study is to assess the clinical usefulness and rationale for routine use of continuous monitoring of lactate in high-risk combined/complex cardiac surgery.

Conditions

Continuous Lactate Measurements; Cardiosurgery

Keywords

Cardiosurgery, lactate

Outcome Measures

Primary Outcomes (1)

• Hyperlactatemia

  Presence of hyperlactatemia (\> 2.0 mmol/l) in the intra- and postoperative period.

  0-24 hrs

Secondary Outcomes (3)

• Cardiac index

  0-24 hrs

• Acute kidney injury

  0-24 hrs

• Respiratory distress

  0-24 hrs

Study Arms (1)

Lactate monitoring

EXPERIMENTAL

The patients in the group will be subjected to the continuous perioperative monitoring of the venous blood lactate

Device: Eirus continuous lactate monitor

Interventions

Eirus continuous lactate monitor DEVICE

a triple-lumen central venous catheter (Eirus TLC) functioning as a regular central venous catheter (CVC) with an integrated microdialysis function will be inserted via the left jugular vein for continuous monitoring of lactate and glucose using Eirus intravascular microdialysis system (Maquet Critical Care, Solna, Sweden) after calibration with arterial sample. Eirus TLC will be used for both drug administration and blood sampling and will be removed postoperatively when a central line will no longer be necessary.

Also known as: Eirus (Maquet)

Lactate monitoring

Eligibility Criteria

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

You may qualify if:

• Informed consent.
• Age above 18 years.
• Presence of coronary artery disease and/or valve regurgitation and/or stenosis
• Elective complex (two and more valves) and combined (valve + CABG) cardiac surgery requiring CPB with expected duration \> 90 min.

You may not qualify if:

• Participation in any other study.
• Morbid obesity (BWI \> 40).

Sponsors & Collaborators

• Northern State Medical University: lead

Study Sites (1)

City hospital # 1 / Northern State Medical University,

Arkhangelsk, 163001, Russia

Location

Study Officials

• Mikhail Y. Kirov, MD, PhD

  Northern State Medical State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Head of Anesthesiology Dept.

Study Record Dates

• First Submitted: September 30, 2015
• First Posted: October 6, 2015
• Study Start: March 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: March 24, 2016

Record last verified: 2016-03

Locations

RU (1)