Etiology of HyperlactathemiaNCT04706884
NEW MONITORING IN DIFFERENTIAL DIAGNOSIS OF HYPERLACTATHEMIA IN CARDIOPULMONARY BYPASS SURGERY
An observational study of Etiology of Hyperlactathemia and Early Period After Cardiopulmonary Bypass Surgery, run by Acibadem University at 2 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 43 to 80 years
- Conditions the study is for
- Etiology of Hyperlactathemia, Early Period After Cardiopulmonary Bypass Surgery, Washout Phenomenon
- What is being tested?
- Near infrared spectroscopy
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Mar 2018to 1 Mar 2019
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 43 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who will undergo elective bypass surgery and extracorporeal circulation
Who may be able to join
- ASA) II-III patients, aged 43-80 years, undergoing on-pump coronary artery bypass grafting
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Acıbadem Mehmet Ali Aydinlar University Atakent Hospital
Istanbul, Atakent, 34303
Acibadem University
Istanbul
About this study
Official title: EFFECT OF CEREBRAL OXYGEN SATURATION ON THE ETIOLOGY OF EARLY POSTOPERATIVE HYPERLACTATEMIA: NEW INDICATION FOR KNOWN MONITORING IN CARDIOPULMONARY BYPASS SURGERY
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.
- Conditions
- Etiology of Hyperlactathemia, Early Period After Cardiopulmonary Bypass Surgery, Washout Phenomenon
- Being tested
- Near infrared spectroscopy
- Keywords
- Early Hyperlactatemia, Cerebral Oxygen Saturation,, Cardiovascular Surgery
- Medical subject headings
- Hyperlactatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near infrared spectroscopyDevice
The rSO2 (cerebral oxygen satutation) was continuously monitored by NIRS (Near infrared spectroscopy) with a sensor positioned on the forehead of the patient
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start1 Mar 2018
- Primary completion1 Feb 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Etiology of HyperlactathemiaStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevket Gorgulu, Acibadem University
- Investigators
- Fevzi Toraman, Prof, Study chair, Acıbadem University School of Medicine Head of Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04706884
- Sponsor's protocol ID
- ATADEK 2018-2/21
- Status last verified
- Jan 2021
- First submitted
- 6 Jan 2021
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF CEREBRAL OXYGEN SATURATION ON THE ETIOLOGY OF EARLY POSTOPERATIVE HYPERLACTATEMIA: NEW INDICATION FOR KNOWN MONITORING IN CARDIOPULMONARY BYPASS SURGERY
- ClinicalTrials.gov ID
- NCT04706884
- Acronym / sponsor ID
- ATADEK 2018-2/21
- Conditions
- Etiology of Hyperlactathemia, Early Period After Cardiopulmonary Bypass Surgery, Washout Phenomenon
- Keywords
- Early Hyperlactatemia, Cerebral Oxygen Saturation,, Cardiovascular Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 13 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 43 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will undergo elective bypass surgery and extracorporeal circulation
Key inclusion criteria (1 listed)
- ASA) II-III patients, aged 43-80 years, undergoing on-pump coronary artery bypass grafting
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Near infrared spectroscopyThe rSO2 (cerebral oxygen satutation) was continuously monitored by NIRS (Near infrared spectroscopy) with a sensor positioned on the forehead of the patient | Device | – |
Primary outcome
Differantial Diagnosis of early hyperlectathemia
Time frame: through study completion, an average of 1 year
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fevzi Toraman, Prof study chair
Acıbadem University School of Medicine Head of Department of Anesthesiology and Reanimation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Etiology of Hyperlactathemia and Early Period After Cardiopulmonary Bypass Surgery, run by Acibadem University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differantial Diagnosis of early hyperlectathemia (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2021.