Fluid Therapy DURING SURGERYTEE LVEDANCT03853031
Transesophageal Echocardiology Measured Left Ventricular End Diastolic Area As Guide for Fluid Therapy in Major Oncosurgeries
A study testing LVEDA cm2 guided intraoperative fluid in TEE /Study Group in people with Fluid Therapy DURING SURGERY, run by Rajiv Gandhi Cancer Institute & Research Center, India at 1 site in India.
Trial summary
Intraoperative fluid management is pivotal to successful outcome of major oncosurgeries . Adequate volume replacement to achieve optimal cardiac performance is critical to prevent any deleterious consequences of under resuscitation or fluid overload . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fluid Therapy DURING SURGERY
- What is being tested?
- LVEDA cm2 guided intraoperative fluid in TEE /Study Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 6 Jan 2019to 10 May 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing major abdominopelvic oncosurgeries .
Who cannot join
- oesophageal varices
- carcinoma oesophagus
- carcinoma stomach
- coagulopathies
- duration of surgery exceeding 8 hours.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transesophageal Echocardiology Measured Left Ventricular End Diastolic Area (LVEDA) As Guide for Fluid Therapy in Major Oncosurgeries
Intraoperative fluid management is pivotal to successful outcome of major oncosurgeries . Adequate volume replacement to achieve optimal cardiac performance is critical to prevent any deleterious consequences of under resuscitation or fluid overload . Traditionally CVP monitoring has been tool to guide intraoperative fluid therapy and has poor reliability as indicator of volume status . Transesophageal Echocardiography measured LVEDA is more reliable and sensitive measure of left ventricular volume to guide intraoperative fluid therapy . Investigators plan the study comparing total fluid requirement and postoperative outcomes in two groups of patients receiving central venous pressure (CVP) guided Conventional Fluid Therapy (CFT) and Left ventricular end diastolic area( LVEDA) guided fluids for major oncosurgeries.
Read the detailed description
Adult patients undergoing major oncosurgeries will be included in the study ,with Alpha Error(%) = 5 ,Power(%)= 80 ,required sample size per group is 29.Investigators will include 30 patients in each group. Patients will be randomly allotted to Central Venous Pressure CVP Group (Control Group) or Transesophageal Echocardiography TEE Group (Study Group) according to computer generated randomization. In the OR 5 lead Electrocardiogram ( ECG ), Oxygen saturation (SPO2 ), Noninvasive blood Pressure (NIBP) , End tidal carbon di oxide (ETCO2 )monitors will be attached .Under local anesthesia 16Gauge peripheral intravenous and Radial artery cannulation will be performed . Anesthesia will be induced with Fentanyl 1mcg/kg-1, Morphine 0.05mg/kg-1, Propofol titrated dosage 1-2 mg/kg-1 and neuromuscular blockade with Atracurium 0.5mg/kg-1.Trachea will be intubated with oral cuffed endotracheal tube of appropriate size. Anaesthesia will be maintained with O2 / Air mixture 40:60 % Intermittent Positive Pressure Ventilation with Sevoflurane , intermittent boluses of Fentanyl and Train of Four ratio guided Atracurium . Postintubation ultrasound guided internal jugular vein will be cannulated with B.Braun 7French 20cm, 16 G Triple lumen central venous catheter in both CVP and TEE Group patients . My Lab Five ESAOTE TEE 022 multiplane probe ,frequency 3 to7MHz (Providian Medical Equipment ,OH) will be placed in TEE Group patients.Intraoperative all patients will be given one-third starvation fluid in first hour of surgery , maintenance fluid 2ml/hour crystalloid . Target is to maintain CVP between 10 -16 cms of water (H20) in CVP Group , values will be recorded every 30 minutes if CVP decreases < 10 then 200 ml colloid bolus will be given and increase in CVP value noted . In the TEE Group TEE probe will be inserted in the oesophagus (40-45 cms) adjusted to obtain mid-papillary transgastric short axis view ,the desired view will be freezed at end-diastole and the left ventricular cavity will be traced including the papillary muscles to obtain left ventricular end diastolic area in cm2 , the average of three readings at particular interval will be noted . Every half hourly values will be measured and also if systolic blood pressure < 90 mm Hg . Fluid therapy will be given with the target to maintain LVEDA ≥ 10 cm2 (ranging between 10-18 cm2). For readings < 10 cm2 colloid bolus 200 ml will be given and increase in the LVEDA will be noted.For same readings Left Ventricular Outflow trac ( LVOT) view will be obtained to measure aortic diameter at the cusps and LVOT VTI , Stroke volume ( SV) will be calculated as LVOT area { Pi (LVOT diameter /2 } 2 × LVOT VTI and Cardiac Outpt will be calculated as SV x Heart Rate . Increase in stoke volume and cardiac output with colloid boluses will be noted.Urine output will be recorded every 30 minutes in all the patients.Titrated noradrenaline infusion (conc 0.08mg/ml ) will be started if Mean Arterial Pressure (MAP) < 70 mmHg with optimal fluid administration in CVP and TEE group .Serum lactate levels will be measured on completion of surgery and postoperative at 24 and 48 hours, neuromuscular blockade will be reversed and trachea extubated . In PACU both groups will receive CVP guided intravenous fluids, monitoring will include heart rate , Blood Pressure ,SPO2 , CVP , urine output. Note will be made of any patient requiring postoperative ventilator support, inotropic support,return of bowel sounds, serum lactate levels and serum creatinine levels at 24 and 48 hours and length of ICU stay.
- Conditions
- Fluid Therapy DURING SURGERY
- Being tested
- LVEDA cm2 guided intraoperative fluid in TEE /Study Group, CVP guided intraoperative fluid in CVP / Control group
- Keywords
- Fluid therapy, Left ventricular end diastolic area, Central venous pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LVEDA cm2 guided intraoperative fluid in TEE /Study GroupProcedure or surgery
Placement of Transoesophageal echocardiography probe in TEE group to measure Left ventricular end diastolic area cm2
CVP guided intraoperative fluid in CVP / Control groupProcedure or surgery
Ultrasound guided Internal Jugular Vein catheter placement in CVP group to measure CVP value cms H2O .
| Study group | Role | What they receive |
|---|---|---|
| LVEDA guided intraoperative fluid therapy | Active comparator | Patients in TEE group will be given crystalloid fluids during surgery guided by LVEDA cm2 to be maintained between 10 -18 cm2 , if LVEDA < 10 cm2 then 200ml colloid bolus will be given and increase in LVEDA noted. Receives: Procedure: LVEDA cm2 guided intraoperative fluid in TEE /Study Group |
| CVP guided intraoperative fluid therapy | Active comparator | Patients in CVP group will be given crystalloid fluids during surgery guided by CVP values to be maintained between 10 -16 cms of water H2O ,if CVP value < 10 cms H2O then 200 ml colloid bolus will be given and increase in CVP value noted. Receives: Procedure: CVP guided intraoperative fluid in CVP / Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
To calculate total intraoperative fluids required in TEE (study) and CVP (control) groups.
During the surgery Study group will receive fluids ( crystalloids and bolus colloids) guided by LVEDA cm2 and Control group will receive fluids (crystalloids and bolus colloids) guided by CVP cms H20
Measured: Upto 8 hours
Secondary outcomes (3)
To compare serum lactate levels in millimols/litre
In both the groups through completion of surgery and at postoperative 24 hours and postoperative 48 hours serum lactate levels will be measured .
Measured: upto 48 hours
To compare serum creatinine in milligrams per decilitre in both the groups
In both groups serum creatinine in milligrams per decilitre will be measured at postoperative 24 and postoperative 48 hours.
Measured: Upto 48 hours.
Length of ICU stay
In both the groups postoperative stay in the ICU will be noted in days.
Measured: Upto 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start6 Jan 2019
- Primary completion30 Apr 2019
- Study completion10 May 2019
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 Fluid Therapy DURING SURGERYStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- During surgery Control group of patients will receive CVP guided fluids Study group of patients will receive TEE measured LVEDA guided fluids
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rajiv Gandhi Cancer Institute & Research Center, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Anita Kulkarni, Rajiv Gandhi Cancer Institute & Research Center, India
- Investigators
- Anita Kulkarni, MD, Principal investigator, Rajiv Gandhi Cancer Institute & Research Centre , IndiaAnita Kulkarni, M.D., Principal investigator, Rajiv Gandhi Cancer Institute & Research Centre , India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03853031
- Sponsor's protocol ID
- RGCIRC Rohini
- Acronym
- TEE LVEDA
- Status last verified
- Jan 2025
- First submitted
- 8 Feb 2019
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gutierrez MC, Moore PG, Liu H. Goal-directed therapy in intraoperative fluid and hemodynamic management. J Biomed Res. 2013 Sep;27(5):357-65. doi: 10.7555/JBR.27.20120128. Epub 2013 Mar 10.
PubMed 24086168Cheung AT, Savino JS, Weiss SJ, Aukburg SJ, Berlin JA. Echocardiographic and hemodynamic indexes of left ventricular preload in patients with normal and abnormal ventricular function. Anesthesiology. 1994 Aug;81(2):376-87. doi: 10.1097/00000542-199408000-00016.
PubMed 8053588Marik PE, Cavallazzi R. Does the central venous pressure predict fluid responsiveness? An updated meta-analysis and a plea for some common sense. Crit Care Med. 2013 Jul;41(7):1774-81. doi: 10.1097/CCM.0b013e31828a25fd.
PubMed 23774337
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transesophageal Echocardiology Measured Left Ventricular End Diastolic Area (LVEDA) As Guide for Fluid Therapy in Major Oncosurgeries
- ClinicalTrials.gov ID
- NCT03853031
- Acronym / sponsor ID
- TEE LVEDA / RGCIRC Rohini
- Conditions
- Fluid Therapy DURING SURGERY
- Keywords
- Fluid therapy, Left ventricular end diastolic area, Central venous pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Rajiv Gandhi Cancer Institute & Research Center, IndiaUniversity, hospital or other
- Study start
- 6 Jan 2019 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 10 May 2019 (actual)
- First posted
- 25 Feb 2019 (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.
Intraoperative fluid management is pivotal to successful outcome of major oncosurgeries . Adequate volume replacement to achieve optimal cardiac performance is critical to prevent any deleterious consequences of under resuscitation or fluid overload . Traditionally CVP monitoring has been tool to guide intraoperative fluid therapy and has poor reliability as indicator of volume status . Transesophageal Echocardiography measured LVEDA is more reliable and sensitive measure of left ventricular volume to guide intraoperative fluid therapy . Investigators plan the study comparing total fluid requirement and postoperative outcomes in two groups of patients receiving central venous pressure (CVP) guided Conventional Fluid Therapy (CFT) and Left ventricular end diastolic area( LVEDA) guided fluids for major oncosurgeries.
Detailed description
Adult patients undergoing major oncosurgeries will be included in the study ,with Alpha Error(%) = 5 ,Power(%)= 80 ,required sample size per group is 29.Investigators will include 30 patients in each group. Patients will be randomly allotted to Central Venous Pressure CVP Group (Control Group) or Transesophageal Echocardiography TEE Group (Study Group) according to computer generated randomization. In the OR 5 lead Electrocardiogram ( ECG ), Oxygen saturation (SPO2 ), Noninvasive blood Pressure (NIBP) , End tidal carbon di oxide (ETCO2 )monitors will be attached .Under local anesthesia 16Gauge peripheral intravenous and Radial artery cannulation will be performed . Anesthesia will be induced with Fentanyl 1mcg/kg-1, Morphine 0.05mg/kg-1, Propofol titrated dosage 1-2 mg/kg-1 and neuromuscular blockade with Atracurium 0.5mg/kg-1.Trachea will be intubated with oral cuffed endotracheal tube of appropriate size. Anaesthesia will be maintained with O2 / Air mixture 40:60 % Intermittent Positive Pressure Ventilation with Sevoflurane , intermittent boluses of Fentanyl and Train of Four ratio guided Atracurium . Postintubation ultrasound guided internal jugular vein will be cannulated with B.Braun 7French 20cm, 16 G Triple lumen central venous catheter in both CVP and TEE Group patients . My Lab Five ESAOTE TEE 022 multiplane probe ,frequency 3 to7MHz (Providian Medical Equipment ,OH) will be placed in TEE Group patients.Intraoperative all patients will be given one-third starvation fluid in first hour of surgery , maintenance fluid 2ml/hour crystalloid . Target is to maintain CVP between 10 -16 cms of water (H20) in CVP Group , values will be recorded every 30 minutes if CVP decreases < 10 then 200 ml colloid bolus will be given and increase in CVP value noted . In the TEE Group TEE probe will be inserted in the oesophagus (40-45 cms) adjusted to obtain mid-papillary transgastric short axis view ,the desired view will be freezed at end-diastole and the left ventricular cavity will be traced including the papillary muscles to obtain left ventricular end diastolic area in cm2 , the average of three readings at particular interval will be noted . Every half hourly values will be measured and also if systolic blood pressure < 90 mm Hg . Fluid therapy will be given with the target to maintain LVEDA ≥ 10 cm2 (ranging between 10-18 cm2). For readings < 10 cm2 colloid bolus 200 ml will be given and increase in the LVEDA will be noted.For same readings Left Ventricular Outflow trac ( LVOT) view will be obtained to measure aortic diameter at the cusps and LVOT VTI , Stroke volume ( SV) will be calculated as LVOT area { Pi (LVOT diameter /2 } 2 × LVOT VTI and Cardiac Outpt will be calculated as SV x Heart Rate . Increase in stoke volume and cardiac output with colloid boluses will be noted.Urine output will be recorded every 30 minutes in all the patients.Titrated noradrenaline infusion (conc 0.08mg/ml ) will be started if Mean Arterial Pressure (MAP) < 70 mmHg with optimal fluid administration in CVP and TEE group .Serum lactate levels will be measured on completion of surgery and postoperative at 24 and 48 hours, neuromuscular blockade will be reversed and trachea extubated . In PACU both groups will receive CVP guided intravenous fluids, monitoring will include heart rate , Blood Pressure ,SPO2 , CVP , urine output. Note will be made of any patient requiring postoperative ventilator support, inotropic support,return of bowel sounds, serum lactate levels and serum creatinine levels at 24 and 48 hours and length of ICU stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- During surgery Control group of patients will receive CVP guided fluids Study group of patients will receive TEE measured LVEDA guided fluids
| Arm | Type | Receives |
|---|---|---|
| LVEDA guided intraoperative fluid therapy | Active comparator | Procedure: LVEDA cm2 guided intraoperative fluid in TEE /Study GroupPatients in TEE group will be given crystalloid fluids during surgery guided by LVEDA cm2 to be maintained between 10 -18 cm2 , if LVEDA < 10 cm2 then 200ml colloid bolus will be given and increase in LVEDA noted. |
| CVP guided intraoperative fluid therapy | Active comparator | Procedure: CVP guided intraoperative fluid in CVP / Control groupPatients in CVP group will be given crystalloid fluids during surgery guided by CVP values to be maintained between 10 -16 cms of water H2O ,if CVP value < 10 cms H2O then 200 ml colloid bolus will be given and increase in CVP value noted. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing major abdominopelvic oncosurgeries .
Key exclusion criteria (5 listed)
- oesophageal varices
- carcinoma oesophagus
- carcinoma stomach
- coagulopathies
- duration of surgery exceeding 8 hours.
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 |
|---|---|---|
| LVEDA cm2 guided intraoperative fluid in TEE /Study GroupPlacement of Transoesophageal echocardiography probe in TEE group to measure Left ventricular end diastolic area cm2 | Procedure or surgery | LVEDA guided intraoperative fluid therapy |
| CVP guided intraoperative fluid in CVP / Control groupUltrasound guided Internal Jugular Vein catheter placement in CVP group to measure CVP value cms H2O . | Procedure or surgery | CVP guided intraoperative fluid therapy |
Primary outcome
To calculate total intraoperative fluids required in TEE (study) and CVP (control) groups.
Time frame: Upto 8 hours
During the surgery Study group will receive fluids ( crystalloids and bolus colloids) guided by LVEDA cm2 and Control group will receive fluids (crystalloids and bolus colloids) guided by CVP cms H20
3 secondary outcomes
To compare serum lactate levels in millimols/litre
Time frame: upto 48 hours
To compare serum creatinine in milligrams per decilitre in both the groups
Time frame: Upto 48 hours.
Length of ICU stay
Time frame: Upto 10 days
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 22 Jan 2025.
- Background: PubMed 24086168Gutierrez MC, Moore PG, Liu H. Goal-directed therapy in intraoperative fluid and hemodynamic management. J Biomed Res. 2013 Sep;27(5):357-65. doi: 10.7555/JBR.27.20120128. Epub 2013 Mar 10.
- Background: PubMed 8053588Cheung AT, Savino JS, Weiss SJ, Aukburg SJ, Berlin JA. Echocardiographic and hemodynamic indexes of left ventricular preload in patients with normal and abnormal ventricular function. Anesthesiology. 1994 Aug;81(2):376-87. doi: 10.1097/00000542-199408000-00016.
- Background: PubMed 23774337Marik PE, Cavallazzi R. Does the central venous pressure predict fluid responsiveness? An updated meta-analysis and a plea for some common sense. Crit Care Med. 2013 Jul;41(7):1774-81. doi: 10.1097/CCM.0b013e31828a25fd.
- 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.
Anita Kulkarni, MD principal investigator
Rajiv Gandhi Cancer Institute & Research Centre , India
Anita Kulkarni, M.D. principal investigator
Rajiv Gandhi Cancer Institute & Research Centre , India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LVEDA cm2 guided intraoperative fluid in TEE /Study Group in people with Fluid Therapy DURING SURGERY, run by Rajiv Gandhi Cancer Institute & Research Center, India at 1 site in India.
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 5 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 22 Jan 2025. 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 India. 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?
To calculate total intraoperative fluids required in TEE (study) and CVP (control) groups. (time frame: Upto 8 hours). 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 NCT03853031, 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 22 Jan 2025.