Fluid TherapyVTI SVVNCT03140540
TEE as a Guide for Fluid Optimization in Major Abdominal Oncosurgery
A study testing TEE guided fluid therapy will be administered and Stroke volume variation guided intravenous fluid. in people with Fluid Therapy, run by Rajiv Gandhi Cancer Institute & Research Center, India at 1 site in India.
Trial summary
Transesophageal echocardiography (TEE) as guide for tailoring perioperative fluid therapy to achieve individualized hemodynamic endpoint, target hemodynamic goals of stroke volume index (SVI) greater than 35 mL/m2 and cardiac index greater than 2.5 L/min/m2 and tissue oxygen delivery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fluid Therapy
- What is being tested?
- TEE guided fluid therapy will be administered and Stroke volume variation guided intravenous fluid.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 16 Feb 2019to 27 Feb 2020
- 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
- ASA 1, 2 and 3
- Undergoing major abdominal oncosurgery
Who cannot join
- Any contraindication for TEE probe insertion as oesophageal varices , oesophageal and gastric carcinoma , severe left ventricular hypertrophy , coagulopathy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transesophageal Echocardiography as a Guide for Fluid Optimization in Major Abdominal Oncosurgery
Transesophageal echocardiography (TEE) as guide for tailoring perioperative fluid therapy to achieve individualized hemodynamic endpoint, target hemodynamic goals of stroke volume index (SVI) greater than 35 mL/m2 and cardiac index greater than 2.5 L/min/m2 and tissue oxygen delivery.
Lactate levels as a surrogate indicator of organ perfusion as measured by arterial blood gas analysis intraoperatively, after 12 hours and 48 hrs postoperatively
Read the detailed description
TEE as guide for tailoring perioperative fluid therapy to achieve target hemodynamic goals of stroke volume index (SVI) greater than 35 mL/m2 and cardiac index greater than 2.5 L/min/m2 and tissue oxygen delivery.
GDT (goal directed therapy): continuous infusion of crystalloids 2 mL/kg/h.
If (velocity time integral) VTI <20, 250 mL colloid bolus administered. Dose repeated every 10 min until goal of VTI >20 met. Norepinephrine titrated to maintain MAP(mean arterial pressure) > 65 mm Hg. Blood transfused for haemoglobin <8 g Lactate levels as a surrogate indicator of organ perfusion as measured by arterial blood gas analysis at time of incision intraoperatively and after 12 hours and 48 hrs. The incidence of postoperative complications, morbidity, mortality, duration of mechanical ventilation and ICU stay.
- Conditions
- Fluid Therapy
- Being tested
- TEE guided fluid therapy will be administered, Stroke volume variation guided intravenous fluid.
- Keywords
- Fluid management, goal-directed therapy, transesophageal echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEE guided fluid therapy will be administeredOther
Transesophageal echocardiography will be used to guide the fluid therapy. Velocity time integral of aorta <20 ,200ml colloid bolus to be administered.
Stroke volume variation guided intravenous fluid.Other
Active Comparator: Group A control group (SVV guided fluid ) Stroke volume variation guided intraoperative intravenous fluid will be administered. SVV >10, 200 ml of colloid bolus to be given
| Study group | Role | What they receive |
|---|---|---|
| Group A (stroke volume variation) guided fluid | Active comparator | Stroke volume variation guided intraoperative intravenous fluid will be administered. Receives: Other: Stroke volume variation guided intravenous fluid. |
| Group B(Study group) TEE guided fluid | Active comparator | Transesophageal echocardiography will be used to guide the fluid therapy. Receives: Other: TEE guided fluid therapy will be administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
The incidence of postoperative complications in percentage
Measured: 48 hours
Secondary outcomes (2)
intraoperative fluid
Amount of intraoperative fluid in litres to be compared
Measured: intraoperative period (hours)
median icu stay
duration of icu stay
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start16 Feb 2019
- Primary completion27 Feb 2020
- Study completion27 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fluid TherapyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- TEE as guide for tailoring perioperative fluid therapy to achieve individualized hemodynamic endpoint , target hemodynamic goals of stroke volume index (SVI) greater than 35 mL/m2 and cardiac index greater than 2.5 L/min/m2 and tissue oxygen delivery. Lactate levels as a surrogate indicator of organ perfusion as measured by arterial blood gas analysis intraoperatively , after 12 hours and 48 hrs postoperatively.
- Masking
- Single blind
- Who is masked
- Care provider
- 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 soumi pathak, Rajiv Gandhi Cancer Institute & Research Center, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140540
- Sponsor's protocol ID
- RGCI ID:500/AN/ANK-02
- Acronym
- VTI SVV
- Status last verified
- Oct 2020
- First submitted
- 15 Apr 2017
- Last updated
- 26 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guarracino F. [The role of transesophageal echocardiography in intraoperative hemodynamic monitoring]. Minerva Anestesiol. 2001 Apr;67(4):320-4. Italian.
PubMed 11376533Trinooson CD, Gold ME. Impact of goal-directed perioperative fluid management in high-risk surgical procedures: a literature review. AANA J. 2013 Oct;81(5):357-68.
PubMed 24354071
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transesophageal Echocardiography as a Guide for Fluid Optimization in Major Abdominal Oncosurgery
- ClinicalTrials.gov ID
- NCT03140540
- Acronym / sponsor ID
- VTI SVV / RGCI ID:500/AN/ANK-02
- Conditions
- Fluid Therapy
- Keywords
- Fluid management, goal-directed therapy, transesophageal echocardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Rajiv Gandhi Cancer Institute & Research Center, IndiaUniversity, hospital or other
- Study start
- 16 Feb 2019 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- 27 Feb 2020 (actual)
- First posted
- 4 May 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.
Transesophageal echocardiography (TEE) as guide for tailoring perioperative fluid therapy to achieve individualized hemodynamic endpoint, target hemodynamic goals of stroke volume index (SVI) greater than 35 mL/m2 and cardiac index greater than 2.5 L/min/m2 and tissue oxygen delivery.
Lactate levels as a surrogate indicator of organ perfusion as measured by arterial blood gas analysis intraoperatively, after 12 hours and 48 hrs postoperatively
Detailed description
TEE as guide for tailoring perioperative fluid therapy to achieve target hemodynamic goals of stroke volume index (SVI) greater than 35 mL/m2 and cardiac index greater than 2.5 L/min/m2 and tissue oxygen delivery.
GDT (goal directed therapy): continuous infusion of crystalloids 2 mL/kg/h.
If (velocity time integral) VTI <20, 250 mL colloid bolus administered. Dose repeated every 10 min until goal of VTI >20 met. Norepinephrine titrated to maintain MAP(mean arterial pressure) > 65 mm Hg. Blood transfused for haemoglobin <8 g Lactate levels as a surrogate indicator of organ perfusion as measured by arterial blood gas analysis at time of incision intraoperatively and after 12 hours and 48 hrs. The incidence of postoperative complications, morbidity, mortality, duration of mechanical ventilation and ICU stay.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- TEE as guide for tailoring perioperative fluid therapy to achieve individualized hemodynamic endpoint , target hemodynamic goals of stroke volume index (SVI) greater than 35 mL/m2 and cardiac index greater than 2.5 L/min/m2 and tissue oxygen delivery. Lactate levels as a surrogate indicator of organ perfusion as measured by arterial blood gas analysis intraoperatively , after 12 hours and 48 hrs postoperatively.
| Arm | Type | Receives |
|---|---|---|
| Group A (stroke volume variation) guided fluid | Active comparator | Other: Stroke volume variation guided intravenous fluid.Stroke volume variation guided intraoperative intravenous fluid will be administered. |
| Group B(Study group) TEE guided fluid | Active comparator | Other: TEE guided fluid therapy will be administeredTransesophageal echocardiography will be used to guide the fluid therapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA 1, 2 and 3
- Undergoing major abdominal oncosurgery
Key exclusion criteria (1 listed)
- Any contraindication for TEE probe insertion as oesophageal varices , oesophageal and gastric carcinoma , severe left ventricular hypertrophy , coagulopathy.
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 |
|---|---|---|
| TEE guided fluid therapy will be administeredTransesophageal echocardiography will be used to guide the fluid therapy. Velocity time integral of aorta <20 ,200ml colloid bolus to be administered. | Other | Group B(Study group) TEE guided fluid |
| Stroke volume variation guided intravenous fluid.Active Comparator: Group A control group (SVV guided fluid ) Stroke volume variation guided intraoperative intravenous fluid will be administered. SVV >10, 200 ml of colloid bolus to be given | Other | Group A (stroke volume variation) guided fluid |
Primary outcome
Postoperative complications
Time frame: 48 hours
The incidence of postoperative complications in percentage
2 secondary outcomes
intraoperative fluid
Time frame: intraoperative period (hours)
median icu stay
Time frame: 1 week
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 26 Oct 2020.
- Results publication: PubMed 11376533Guarracino F. [The role of transesophageal echocardiography in intraoperative hemodynamic monitoring]. Minerva Anestesiol. 2001 Apr;67(4):320-4. Italian.
- Results publication: PubMed 24354071Trinooson CD, Gold ME. Impact of goal-directed perioperative fluid management in high-risk surgical procedures: a literature review. AANA J. 2013 Oct;81(5):357-68.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEE guided fluid therapy will be administered and Stroke volume variation guided intravenous fluid. in people with Fluid Therapy, 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 2 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 26 Oct 2020. 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?
Postoperative complications (time frame: 48 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 NCT03140540, which also lists 2 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 26 Oct 2020.