AnesthesiaNCT03103373
Assessment of Plasma Lactate in Non-cardiac Surgery Monitoring by Transthoracic Echocardiography
A study testing Conventional monitor and Echocardiography in people with Anesthesia, run by Federal University of Juiz de Fora at 1 site in Brazil.
Trial summary
The study is a clinical trial, prospective and randomized of 60 patients of both genders, aged between 18 and 80 years, underwent major abdominal surgery. This study aims to compare plasma lactate levels in patients underwent major abdominal surgery (colectomy, gastrectomy, esophagectomy, pancreatectomy, Wertheim… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Conventional monitor and Echocardiography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2017to 1 Jan 2018
- Phase
- Interventional
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ages between 18 and 80 years.
- both genders
- Large abdominal surgeries
- Elective surgeries
Who cannot join
- Emergency surgeries
- Surgeries of the abdominal aorta
- Ejection fraction <30%
- Blood creatinine levels> 2.0mg / dl
- Glycemia> 200 g / dl
- Do not agree to participate in the study
Show all 10Show fewer
- Bowel obstruction
- Sepsis
- Bilirubin> 300 g / dl
- Alcoholism
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
federal University of Juiz de Fora
Juiz de Fora, Minas Gerais, 36036-900
Marcello F Salgado Filho, PhD, +5532999858833, mfonsecasalgado@hotmail.com
Marcello F. Salgado Filho, PhD
About this study
Official title: Assessment of Plasma Lactate in Patients Underwent Non-cardiac Surgery Monitoring by Transthoracic Echocardiography
The study is a clinical trial, prospective and randomized of 60 patients of both genders, aged between 18 and 80 years, underwent major abdominal surgery. This study aims to compare plasma lactate levels in patients underwent major abdominal surgery (colectomy, gastrectomy, esophagectomy, pancreatectomy, Wertheim Meigs, liver and spleen surgeries) monitored by echocardiography or by conventional techniques (mean arterial pressure , Central venous pressure).
Read the detailed description
The study is a clinical trial, prospective and randomized of 60 patients of both genders, aged between 18 and 80 years, underwent major abdominal surgery. This study aims to compare plasma lactate levels in patients underwent major abdominal surgery (colectomy, gastrectomy, esophagectomy, pancreatectomy, Wertheim Meigs, liver and spleen surgeries) monitored by echocardiography or by conventional techniques (mean arterial pressure , Central venous pressure).
The investigators expect to observe a decrease in plasma lactate levels in patients submitted to echocardiographic monitoring when compared to patients submitted to conventional monitoring. In this way, to demonstrate that the routine use of transthoracic echocardiography in patients submitted to large surgery improves the clinical outcomes of these patients and presents a lower hospital cost.
The surgical indication will obey the criteria of the Federal University of Juiz de Fora surgery service, after clinical examination and routine preoperative laboratory tests (complete blood count, complete coagulogram, plasma sodium, potassium Plasma urea and plasma creatinine, blood glucose and liver function test), resting electrocardiogram and chest X-ray. All patients who agree to participate in the study will sign an Informed Consent Term in the preanesthetic evaluation (Appendix 1).
Patients will be computer randomly form by the GraphPad Prisma® program into two groups with 30 patients:
Conventional Group, Transthoracic Echocardiogram Group, All survey data will be noted in the Protocol Data Sheet (Appendix 2). Patients will be anesthetized by the researcher Dr. Marcello Fonseca Salgado Filho, who will also be responsible for performing the intraoperative TTE examination.
- Conditions
- Anesthesia
- Being tested
- Conventional monitor, Echocardiography
- Keywords
- Echocardiography, anesthesia, general surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional monitorDevice
Patients underwent non-cardiac surgery will be monitoring by regular monitors
EchocardiographyDevice
Patients will be monitoring by regular monitors plus echocardiography
| Study group | Role | What they receive |
|---|---|---|
| Conventional monitor group | Active comparator | Patients will be monitoring with invasive blood pressure, central venus catheter, plasma lactate, urinary output, oximeter, capnography and electrocardiography Echocardiography group: Patients will be monitoring with echocardiography, invasive blood pressure, central venus catheter, plasma lactate, urinary output, oximeter, capnogrphy and electrocardiography Receives: Device: Conventional monitor |
| Echocardiography group | Active comparator | Patients will be monitoring with echocardiography, invasive blood pressure, central venus catheter, plasma lactate, urinary output, oximeter, capnography and electrocardiography Receives: Device: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma lactate
The plasma lactate will be collected in the arterial line
Measured: 10 minutes after intubation, before incision
plasma lactate
The plasma lactate will be collected in the arterial line
Measured: 10 min after the end of the surgery
Secondary outcomes (12)
Assessment heart rate
Heart rate
Measured: 10 minutes after intubation, before incision
Assessment heart rate
Heart rate
Measured: 10 min after the end of the surgery
Assessment blood pressure
blood pressure
Measured: 10 minutes after intubation, before incision
Assessment blood pressure
blood pressure
Measured: 10 min after the end of the surgery
Assessment venus oximetry
venus oximetry
Measured: 10 minutes after intubation, before incision
Assessment venus oximetry
venus oximetry
Measured: 10 min after the end of the surgery
Assessment arterial PH
arterial PH
Measured: 10 minutes after intubation, before incision
Assessment arterial PH
arterial PH
Measured: 10 min after the end of the surgery
Assessment fluid infusion
fluid infusion
Measured: 10 min after the end of the surgery
Infection
Assessment sepsis
Measured: 30 days after surgery
Surgery complications
Assessment fistulae
Measured: 30 days after surgery
Post-operative mortality
death after surgery
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start1 Feb 2017
- Primary completion1 Dec 2017 (estimated)
- Study completion1 Jan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a clinical trial, prospective and random type, in which 60 patients, of both genders, aged between 18 and 80 years, who will undergo major abdominal surgery, divided in two groups. Patients will be randomly divided into two groups with 35 patients: Conventional Group, Transthoracic Echocardiogram Group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Juiz de Fora
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcello F Salgado Filho, MD, Federal University of Juiz de Fora
- Investigators
- Marcello F Salgado Filho, PhD, Principal investigator, Federal University of Juiz de Fora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03103373
- Sponsor's protocol ID
- CAAE: 60721816.9.0000.5139
- Status last verified
- Mar 2017
- First submitted
- 10 Mar 2017
- Last updated
- 6 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Forget P, Lois F, de Kock M. Goal-directed fluid management based on the pulse oximeter-derived pleth variability index reduces lactate levels and improves fluid management. Anesth Analg. 2010 Oct;111(4):910-4. doi: 10.1213/ANE.0b013e3181eb624f. Epub 2010 Aug 12.
PubMed 20705785Lobo SM, Rezende E, Knibel MF, Silva NB, Paramo JA, Nacul FE, Mendes CL, Assuncao M, Costa RC, Grion CC, Pinto SF, Mello PM, Maia MO, Duarte PA, Gutierrez F, Silva JM Jr, Lopes MR, Cordeiro JA, Mellot C. Early determinants of death due to multiple organ failure after noncardiac surgery in high-risk patients. Anesth Analg. 2011 Apr;112(4):877-83. doi: 10.1213/ANE.0b013e3181e2bf8e. Epub 2010 Jun 8.
PubMed 20530615Grocott MP, Dushianthan A, Hamilton MA, Mythen MG, Harrison D, Rowan K; Optimisation Systematic Review Steering Group. Perioperative increase in global blood flow to explicit defined goals and outcomes following surgery. Cochrane Database Syst Rev. 2012 Nov 14;11(11):CD004082. doi: 10.1002/14651858.CD004082.pub5.
PubMed 23152223
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Plasma Lactate in Patients Underwent Non-cardiac Surgery Monitoring by Transthoracic Echocardiography
- ClinicalTrials.gov ID
- NCT03103373
- Acronym / sponsor ID
- CAAE: 60721816.9.0000.5139
- Conditions
- Anesthesia
- Keywords
- Echocardiography, anesthesia, general surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Federal University of Juiz de ForaUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Dec 2017 (estimated)
- Study completion
- 1 Jan 2018 (estimated)
- First posted
- 6 Apr 2017 (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.
The study is a clinical trial, prospective and randomized of 60 patients of both genders, aged between 18 and 80 years, underwent major abdominal surgery. This study aims to compare plasma lactate levels in patients underwent major abdominal surgery (colectomy, gastrectomy, esophagectomy, pancreatectomy, Wertheim Meigs, liver and spleen surgeries) monitored by echocardiography or by conventional techniques (mean arterial pressure , Central venous pressure).
Detailed description
The study is a clinical trial, prospective and randomized of 60 patients of both genders, aged between 18 and 80 years, underwent major abdominal surgery. This study aims to compare plasma lactate levels in patients underwent major abdominal surgery (colectomy, gastrectomy, esophagectomy, pancreatectomy, Wertheim Meigs, liver and spleen surgeries) monitored by echocardiography or by conventional techniques (mean arterial pressure , Central venous pressure).
The investigators expect to observe a decrease in plasma lactate levels in patients submitted to echocardiographic monitoring when compared to patients submitted to conventional monitoring. In this way, to demonstrate that the routine use of transthoracic echocardiography in patients submitted to large surgery improves the clinical outcomes of these patients and presents a lower hospital cost.
The surgical indication will obey the criteria of the Federal University of Juiz de Fora surgery service, after clinical examination and routine preoperative laboratory tests (complete blood count, complete coagulogram, plasma sodium, potassium Plasma urea and plasma creatinine, blood glucose and liver function test), resting electrocardiogram and chest X-ray. All patients who agree to participate in the study will sign an Informed Consent Term in the preanesthetic evaluation (Appendix 1).
Patients will be computer randomly form by the GraphPad Prisma® program into two groups with 30 patients:
Conventional Group, Transthoracic Echocardiogram Group, All survey data will be noted in the Protocol Data Sheet (Appendix 2). Patients will be anesthetized by the researcher Dr. Marcello Fonseca Salgado Filho, who will also be responsible for performing the intraoperative TTE examination.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is a clinical trial, prospective and random type, in which 60 patients, of both genders, aged between 18 and 80 years, who will undergo major abdominal surgery, divided in two groups. Patients will be randomly divided into two groups with 35 patients: Conventional Group, Transthoracic Echocardiogram Group
| Arm | Type | Receives |
|---|---|---|
| Conventional monitor group | Active comparator | Device: Conventional monitorPatients will be monitoring with invasive blood pressure, central venus catheter, plasma lactate, urinary output, oximeter, capnography and electrocardiography Echocardiography group: Patients will be monitoring with echocardiography, invasive blood pressure, central venus catheter, plasma lactate, urinary output, oximeter, capnogrphy and electrocardiography |
| Echocardiography group | Active comparator | Device: EchocardiographyPatients will be monitoring with echocardiography, invasive blood pressure, central venus catheter, plasma lactate, urinary output, oximeter, capnography and electrocardiography |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ages between 18 and 80 years.
- both genders
- Large abdominal surgeries
- Elective surgeries
Key exclusion criteria (10 listed)
- Emergency surgeries
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 |
|---|---|---|
| Conventional monitorPatients underwent non-cardiac surgery will be monitoring by regular monitors | Device | Conventional monitor group |
| EchocardiographyPatients will be monitoring by regular monitors plus echocardiography | Device | Echocardiography group |
Primary outcome
plasma lactate
Time frame: 10 minutes after intubation, before incision
The plasma lactate will be collected in the arterial line
plasma lactate
Time frame: 10 min after the end of the surgery
The plasma lactate will be collected in the arterial line
12 secondary outcomes
Assessment heart rate
Time frame: 10 minutes after intubation, before incision
Assessment heart rate
Time frame: 10 min after the end of the surgery
Assessment blood pressure
Time frame: 10 minutes after intubation, before incision
Assessment blood pressure
Time frame: 10 min after the end of the surgery
Assessment venus oximetry
Time frame: 10 minutes after intubation, before incision
Assessment venus oximetry
Time frame: 10 min after the end of the surgery
Assessment arterial PH
Time frame: 10 minutes after intubation, before incision
Assessment arterial PH
Time frame: 10 min after the end of the surgery
Assessment fluid infusion
Time frame: 10 min after the end of the surgery
Infection
Time frame: 30 days after surgery
Surgery complications
Time frame: 30 days after surgery
Post-operative mortality
Time frame: 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
- Results publication: PubMed 20705785Forget P, Lois F, de Kock M. Goal-directed fluid management based on the pulse oximeter-derived pleth variability index reduces lactate levels and improves fluid management. Anesth Analg. 2010 Oct;111(4):910-4. doi: 10.1213/ANE.0b013e3181eb624f. Epub 2010 Aug 12.
- Results publication: PubMed 20530615Lobo SM, Rezende E, Knibel MF, Silva NB, Paramo JA, Nacul FE, Mendes CL, Assuncao M, Costa RC, Grion CC, Pinto SF, Mello PM, Maia MO, Duarte PA, Gutierrez F, Silva JM Jr, Lopes MR, Cordeiro JA, Mellot C. Early determinants of death due to multiple organ failure after noncardiac surgery in high-risk patients. Anesth Analg. 2011 Apr;112(4):877-83. doi: 10.1213/ANE.0b013e3181e2bf8e. Epub 2010 Jun 8.
- Results publication: PubMed 23152223Grocott MP, Dushianthan A, Hamilton MA, Mythen MG, Harrison D, Rowan K; Optimisation Systematic Review Steering Group. Perioperative increase in global blood flow to explicit defined goals and outcomes following surgery. Cochrane Database Syst Rev. 2012 Nov 14;11(11):CD004082. doi: 10.1002/14651858.CD004082.pub5.
- anesthesia and analgesiaLink provided by the sponsor.
- cochraneLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Marcello F Salgado Filho, PhD principal investigator
Federal University of Juiz de Fora
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional monitor and Echocardiography in people with Anesthesia, run by Federal University of Juiz de Fora at 1 site in Brazil.
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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcello F Salgado Filho, PhD (+5532999858833, mfonsecasalgado@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma lactate (time frame: 10 minutes after intubation, before incision). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03103373, which also lists 3 linked publications.
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 6 Apr 2017.