Goal Directed Fluid TherapySVV PVI GDFTNCT05142163
Stroke Volume Variation and Plethysmography Variability Index as Goal Directed Fluid Therapy in Major Oncosurgeries
A study testing Intraoperative SVV Guided Fluid Therapy and Intraoperative PVI Guided Fluid Therapy in people with Goal Directed Fluid Therapy, run by Rajiv Gandhi Cancer Institute & Research Center, India at 1 site in India.
Trial summary
Patients were allotted to two Groups , SVV Guided Fluid Therapy Group received intraoperative fluids to maintain SVV <11 , and PVI Guided Group received intraoperative Fluids to maintain PVI<11 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Goal Directed Fluid Therapy
- What is being tested?
- Intraoperative SVV Guided Fluid Therapy and Intraoperative PVI Guided Fluid Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteIndia
- Study dates
- 8 Nov 2021to 15 Jun 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing Open major Oncosurgeries under General Anaesthesia
Who cannot join
- Patient Refusal
- Left ventricular Ejection Fraction <40%
- Cardiac arrythmias
- Severe valvular heart disease
- Peripheral Vascular Disease
- Laparoscopic surgeries
Trial locations and contacts
1 site in 1 country.
About this study
Patients were allotted to two Groups , SVV Guided Fluid Therapy Group received intraoperative fluids to maintain SVV <11 , and PVI Guided Group received intraoperative Fluids to maintain PVI<11
Read the detailed description
Preinduction Epidural catheter will be placed and Standard General Anaesthesia with Volume Controlled Ventilation (Tidal Volume 8ml/Kilogram ) and Positive End Expiratory Pressure 5 centimeters of water for all patients. Postinduction Radial artery cannulation and Ultrasound guided Internal Jugular cannulation will be performed for all patients .Maintenance Fluid crystalloids 2ml/kg will be given to both the Groups. In Stroke Volume Variation SVV Group Flotrac Transducer (MHD8 model Edwards Lifesciences LLC, Irvine,CA 92614,USA) will be attached to radial artery cannula to obtain SVV values and for values > 11 colloid bolus 200ml will be given over 10 minutes and postbolus values noted. In Plethysmography Variability Index PVI Group pulse Oximeter will be placed on index finger and covered to avoid ambient light will be attached to Masimo Radical 97 Monitor to measure continuous Perfusion Index and Plethysmography Variability Index for values >11 colloid bolus 200ml will be given over 10 minutes and change in PVI value noted. Intraoperative heart rate , Mean arterial Pressure , Oxygen Saturation, End tidal carbon dioxide, Central venous pressure , Urine output will be measured in all patients.With optimal fluids if Mean Arterial Pressure is below 70 mmHg than titrating dosage Norepinephrine infusion will be commenced.At the end of surgery reversal agents will be administered and trachea extubated , note will be made of any patient requiring postoperative ventilator support.Arterial blood gas analysis will be performed at beginning and end of surgery and at postoperative 24 and 48 hours to measure serum lactate levels . Patient will be monitored in Postanaesthesia Care Unit for any Cardiac , Respiratory event , Serum Creatinine levels will be measures at 24 and 48 hours , Appearance of bowel sounds will be noted , Length of ICU stay will be recorded for all patients.
- Conditions
- Goal Directed Fluid Therapy
- Being tested
- Intraoperative SVV Guided Fluid Therapy, Intraoperative PVI Guided Fluid Therapy
- Keywords
- Goal directed Fluid Therapy, Stroke Volume Variation, Plethysmography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative SVV Guided Fluid TherapyOther
Patients will receive intraoperative maintenance Fluids as crystalloids to maintain SVV <11%, for values >11%colloid bolus 6%hydroxyethyl starch will be given and fluid responsiveness noted.
Intraoperative PVI Guided Fluid TherapyOther
Patients will receive intraoperative maintenance Fluids as crystalloids to maintain PVI <10%, for values >10%colloid bolus 6%hydroxyethyl starch will be given and fluid responsiveness noted.
| Study group | Role | What they receive |
|---|---|---|
| Stroke Volume Variation Guided Fluid Therapy | Active comparator | Patients will receive maintenance Fluids as crystalloids intraoperative to maintain SVV <11%, for values >11%colloid bolus 6%hydroxyethyl starch will be given and fluid responsiveness noted. Receives: Other: Intraoperative SVV Guided Fluid Therapy |
| Plethysmography Variability Index Guided Fluid Therapy | Active comparator | Patients will receive maintenance Fluids as crystalloids intraoperative to maintain PVI <11%, for values >11%colloid bolus 6%hydroxyethyl starch will be given and fluid responsiveness noted. Receives: Other: Intraoperative PVI Guided Fluid Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare Total intraoperative Fluid requirement in millilitres and Fluid Responsiveness in SVV and PVI Group.
Patients in SVV Group will receive Crystalloids and colloid bolus 200ml to maintain SVV <11 .Patients in PVI Group will receive Crystalloids and colloid bolus to maintain PVI<11, Postbolus response to SVV and PVI values will be noted.
Measured: upto 8 hours
Secondary outcomes (5)
To Measure Serum Lactate levels mmol/L in SVV and PVI Group.
Intraoperative at beginning and end of surgery and upto 72 hours serum Lactate levels will
be measured.
Measured: upto 72 hours postoperative
Postoperative Cardiac complication
Requirement of Inotrope Nonadrenaline
Measured: upto72 hours
Postoperative Respiratory complication
Ventilator support
Measured: upto 72 hours
Postoperative Renal complication
Increase serum creatinine values
Measured: upto72 hours
Length of ICU stay
Duration in hours stay in PACU
Measured: upto72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start8 Nov 2021
- Primary completion10 Jun 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Goal Directed 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were allotted to either SVV Guided or PVI Guided Intraoperative Fluid Therapy
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 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, Senior Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142163
- Sponsor's protocol ID
- RGCI/GDFT
- Acronym
- SVV PVI GDFT
- Status last verified
- Mar 2024
- First submitted
- 6 Nov 2021
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke Volume Variation and Plethysmography Variability Index as Goal Directed Fluid Therapy in Major Oncosurgeries
- ClinicalTrials.gov ID
- NCT05142163
- Acronym / sponsor ID
- SVV PVI GDFT / RGCI/GDFT
- Conditions
- Goal Directed Fluid Therapy
- Keywords
- Goal directed Fluid Therapy, Stroke Volume Variation, Plethysmography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Rajiv Gandhi Cancer Institute & Research Center, IndiaUniversity, hospital or other
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 10 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 2 Dec 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.
Patients were allotted to two Groups , SVV Guided Fluid Therapy Group received intraoperative fluids to maintain SVV <11 , and PVI Guided Group received intraoperative Fluids to maintain PVI<11
Detailed description
Preinduction Epidural catheter will be placed and Standard General Anaesthesia with Volume Controlled Ventilation (Tidal Volume 8ml/Kilogram ) and Positive End Expiratory Pressure 5 centimeters of water for all patients. Postinduction Radial artery cannulation and Ultrasound guided Internal Jugular cannulation will be performed for all patients .Maintenance Fluid crystalloids 2ml/kg will be given to both the Groups. In Stroke Volume Variation SVV Group Flotrac Transducer (MHD8 model Edwards Lifesciences LLC, Irvine,CA 92614,USA) will be attached to radial artery cannula to obtain SVV values and for values > 11 colloid bolus 200ml will be given over 10 minutes and postbolus values noted. In Plethysmography Variability Index PVI Group pulse Oximeter will be placed on index finger and covered to avoid ambient light will be attached to Masimo Radical 97 Monitor to measure continuous Perfusion Index and Plethysmography Variability Index for values >11 colloid bolus 200ml will be given over 10 minutes and change in PVI value noted. Intraoperative heart rate , Mean arterial Pressure , Oxygen Saturation, End tidal carbon dioxide, Central venous pressure , Urine output will be measured in all patients.With optimal fluids if Mean Arterial Pressure is below 70 mmHg than titrating dosage Norepinephrine infusion will be commenced.At the end of surgery reversal agents will be administered and trachea extubated , note will be made of any patient requiring postoperative ventilator support.Arterial blood gas analysis will be performed at beginning and end of surgery and at postoperative 24 and 48 hours to measure serum lactate levels . Patient will be monitored in Postanaesthesia Care Unit for any Cardiac , Respiratory event , Serum Creatinine levels will be measures at 24 and 48 hours , Appearance of bowel sounds will be noted , Length of ICU stay will be recorded for all patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients were allotted to either SVV Guided or PVI Guided Intraoperative Fluid Therapy
| Arm | Type | Receives |
|---|---|---|
| Stroke Volume Variation Guided Fluid Therapy | Active comparator | Other: Intraoperative SVV Guided Fluid TherapyPatients will receive maintenance Fluids as crystalloids intraoperative to maintain SVV <11%, for values >11%colloid bolus 6%hydroxyethyl starch will be given and fluid responsiveness noted. |
| Plethysmography Variability Index Guided Fluid Therapy | Active comparator | Other: Intraoperative PVI Guided Fluid TherapyPatients will receive maintenance Fluids as crystalloids intraoperative to maintain PVI <11%, for values >11%colloid bolus 6%hydroxyethyl starch will be given and fluid responsiveness noted. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing Open major Oncosurgeries under General Anaesthesia
Key exclusion criteria (6 listed)
- Patient Refusal
- Left ventricular Ejection Fraction <40%
- Cardiac arrythmias
- Severe valvular heart disease
- Peripheral Vascular Disease
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 |
|---|---|---|
| Intraoperative SVV Guided Fluid TherapyPatients will receive intraoperative maintenance Fluids as crystalloids to maintain SVV <11%, for values >11%colloid bolus 6%hydroxyethyl starch will be given and fluid responsiveness noted. | Other | Stroke Volume Variation Guided Fluid Therapy |
| Intraoperative PVI Guided Fluid TherapyPatients will receive intraoperative maintenance Fluids as crystalloids to maintain PVI <10%, for values >10%colloid bolus 6%hydroxyethyl starch will be given and fluid responsiveness noted. | Other | Plethysmography Variability Index Guided Fluid Therapy |
Primary outcome
To compare Total intraoperative Fluid requirement in millilitres and Fluid Responsiveness in SVV and PVI Group.
Time frame: upto 8 hours
Patients in SVV Group will receive Crystalloids and colloid bolus 200ml to maintain SVV <11 .Patients in PVI Group will receive Crystalloids and colloid bolus to maintain PVI<11, Postbolus response to SVV and PVI values will be noted.
5 secondary outcomes
To Measure Serum Lactate levels mmol/L in SVV and PVI Group.
Time frame: upto 72 hours postoperative
Postoperative Cardiac complication
Time frame: upto72 hours
Postoperative Respiratory complication
Time frame: upto 72 hours
Postoperative Renal complication
Time frame: upto72 hours
Length of ICU stay
Time frame: upto72 hours
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 5 Mar 2024.
- 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
Senior Consultant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative SVV Guided Fluid Therapy and Intraoperative PVI Guided Fluid Therapy in people with Goal Directed 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 1 inclusion and 6 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 5 Mar 2024. 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 compare Total intraoperative Fluid requirement in millilitres and Fluid Responsiveness in SVV and PVI Group. (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?
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 5 Mar 2024.