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CompletedNCT04706884Updated Jan 14, 2021

NEW MONITORING IN DIFFERENTIAL DIAGNOSIS OF HYPERLACTATHEMIA IN CARDIOPULMONARY BYPASS SURGERY

An observational study in Etiology of Hyperlactathemia, Early Period After Cardiopulmonary Bypass Surgery and Washout Phenomenon, sponsored by Acibadem University. Completed at 2 sites in Turkey. Open to participants aged 43 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-01-14.

Sponsored by Acibadem University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Ages
43 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

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

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Keywords

  • Early Hyperlactatemia
  • Cerebral Oxygen Saturation,
  • Cardiovascular Surgery
03

In context

Hyperlactatemia

50 studies on the registry are indexed under Hyperlactatemia; 7 are open to participants now.

This study's enrollment of 60 is below the median of 136 across 17 observational studies indexed under Hyperlactatemia.

Browse Hyperlactatemia studies →

Lead sponsor

Acibadem University is the lead sponsor of 220 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
43 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients who will undergo elective bypass surgery and extracorporeal circulation

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (actual)
Target follow-up
1 Year
Patient registry
Yes

Interventions

  • DeviceNear 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

06

What researchers measure

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)

    Time frame: through study completion, an average of 1 year

07

Study locations

2 sites
  • Acıbadem Mehmet Ali Aydinlar University Atakent Hospital
    Istanbul, Atakent 34303, Turkey
  • Acibadem University
    İstanbul, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04706884
Responsible party
Sevket Gorgulu (Head of Anesthesiology, Acibadem University) — Principal investigator
First posted
Jan 13, 2021
Start date
Mar 1, 2018
Primary completion
Feb 1, 2019
Completion
Mar 1, 2019
Last update
Jan 14, 2021

Study contacts

Fevzi Toraman, Prof
study chair · Acıbadem University School of Medicine Head of Department of Anesthesiology and Reanimation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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