NEW MONITORING IN DIFFERENTIAL DIAGNOSIS OF HYPERLACTATHEMIA IN CARDIOPULMONARY BYPASS SURGERY

NCT04706884 | Completed FDA Device

• 1 other identifier: ATADEK 2018-2/21
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Objective: The objective of the study was to investigate a reverse correlation between blood lactate levels and rSO2, and distinguish between hypoxic and non-hypoxic hyperlactatemia seen in the early postoperative period.

Conditions

Etiology of Hyperlactathemia; Early Period After Cardiopulmonary Bypass Surgery; Washout Phenomenon

Keywords

Early Hyperlactatemia; Cerebral Oxygen Saturation,; Cardiovascular Surgery

Outcome Measures

Primary Outcomes (1)

• Differantial Diagnosis of early hyperlectathemia

  To understand whether early hyperlactathemia after cardiopulmonary bypass surgery is due to hypoxic or non-hypoxic causes, we will look at the correlation between blood lactate level and cerebral oxygen saturation (rSO2)

  through study completion, an average of 1 year

Interventions

Near infrared spectroscopy DEVICE

The rSO2 (cerebral oxygen satutation) was continuously monitored by NIRS (Near infrared spectroscopy) with a sensor positioned on the forehead of the patient

Eligibility Criteria

• Age: 43 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who will undergo elective bypass surgery and extracorporeal circulation

You may qualify if:

• ASA) II-III patients, aged 43-80 years, undergoing on-pump coronary artery bypass grafting

You may not qualify if:

• Active congestive cardiac failure, intraoperative death, urgent cardiac surgery or reoperation, hemodynamic instability or need of inotropic support before the operation, the elevation of any parameters preoperatively suggestive of systemic hypoperfusion, coagulopathy, renal failure, hepatic dysfunction, local or systemic infection, and inflammation.

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (2)

Acıbadem Mehmet Ali Aydinlar University Atakent Hospital

Istanbul, Atakent, 34303, Turkey (Türkiye)

Location

Acibadem University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hyperlactatemia

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Fevzi Toraman, Prof

  Acıbadem University School of Medicine Head of Department of Anesthesiology and Reanimation

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Anesthesiology

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 13, 2021
• Study Start: March 1, 2018
• Primary Completion: February 1, 2019
• Study Completion: March 1, 2019
• Last Updated: January 14, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)