NEW MONITORING IN DIFFERENTIAL DIAGNOSIS OF HYPERLACTATHEMIA IN CARDIOPULMONARY BYPASS SURGERY

Early Period After Cardiopulmonary Bypass Surgery Clinical Trial

Official title:

EFFECT OF CEREBRAL OXYGEN SATURATION ON THE ETIOLOGY OF EARLY POSTOPERATIVE HYPERLACTATEMIA: NEW INDICATION FOR KNOWN MONITORING IN CARDIOPULMONARY BYPASS SURGERY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04706884
• Other study ID #: ATADEK 2018-2/21
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: January 2021
• Source: Acibadem University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

The objective of the prospective 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.

Sixty American Society of Anesthesiologists (ASA) II-III patients were included in this study. Perioperative data, including age, weight, body surface area, gender, body temperature, preoperative co-morbidities, intraoperative and postoperative hemodynamic parameters, arterial blood gas analysis (ABG), cardiopulmonary bypass and aortic cross-clamp duration, flow rate, urine output, and blood product and inotropic agent usage, were recorded. Postoperative plasma lactate levels were measured simultaneously with cerebral tissue oxygen saturation (rSO2) in both cerebral hemispheres at 10 different time points.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 43 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Early Period After Cardiopulmonary Bypass Surgery
• Etiology of Hyperlactathemia
• Hyperlactatemia
• Washout Phenomenon

Intervention

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

Locations

Country	Name	City	State
Turkey	Acibadem Mehmet Ali Aydinlar University Atakent Hospital	Istanbul	Atakent
Turkey	Acibadem University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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