Fluid LossGDFT ERASNCT06026475
Role of Goal Directed Fluid Therapy in Enhanced Recovery After Surgery in Gastro-intestinal Oncosurgeries
A study testing Goal directed Fluid Therapy and Conventional Fluid Therapy in people with Fluid Loss and Enhanced Recovery, run by Rajiv Gandhi Cancer Institute & Research Center, India at 1 site in India.
Trial summary
Enhanced recovery after surgery (ERAS) protocols are multimodal perioperative care pathways designed to achieve early recovery and reducing postoperative morbidity after surgical procedures by maintaining preoperative organ function and reducing the profound stress response following surgery .The key elements of ERAS… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fluid Loss, Enhanced Recovery
- What is being tested?
- Goal directed Fluid Therapy and Conventional Fluid Therapy
- 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
- 13 Jul 2023to 30 Jan 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective major open gastrointestinal Oncosurgeries .
Who cannot join
- Patient refusal.
- Robotic surgery.
- Laparoscopic surgery.
- Arrythmias.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Goal Directed Fluid Therapy in Enhanced Recovery After Surgery in Gastro-intestinal Onco-surgeries
Enhanced recovery after surgery (ERAS) protocols are multimodal perioperative care pathways designed to achieve early recovery and reducing postoperative morbidity after surgical procedures by maintaining preoperative organ function and reducing the profound stress response following surgery .The key elements of ERAS protocols include preoperative counselling, optimization of nutrition, standardized analgesic and anesthetic regimens , goal directed fluid therapy early mobilization.
Read the detailed description
For the proposed study investigators plan to include total 60 patients with 30 each allotted to GDFT(SVV) and CVP Group ,belonging to ASA ( American Society of Anesthesiology)Grade I/II/III, study will be conducted after obtaining written informed consent from all patients and approval from the scientific committee and Institutional Review Board (IRB). All patients will receive one-third starvation fluid as crystalloid during first hour of surgery . Night prior to and on the day of surgery carbo load will be given to all patients according to the protocol.Monitoring included 5 lead ECG SPO2,ETCO2, Invasive Blood Pressure (IBP - Radial),CVP(site IJV),core Temperature .
Standard General anaesthesia with oral Endotracheal tube and Intermittent Positive Pressure Ventilation will be given to all patients.Patients will be allotted randomly to either Goal Directed Fluid Therapy (GDFT) /SVV - Stroke Volume Variation or Conventional Central Venous Pressure - CVP guided fluid Therapy Group.
During the surgery - Heart rate , Mean arterial Blood Pressure , Urine output , Blood loss , Seum lactate levels will be noted.
For SVV Group - SVV , Stroke Volume Index (SVI) , Systemic vascular resistance index (SVRI) ,Cardiac Index (CI) values will be noted every 30 minutes- the goal is to maintain SVV value >11 and to give colloid bolus 200ml whenever SVV values rise above11.Pre and post bolus SVV, SV, SVI and SVRI shall be recorded.
For CVP Group - Goal is to maintain CVP values between 8-12 cmsH20 and for decrease in value < 8 colloid bolus of 200ml will be given and change in CVP value will be noted.
Patients in both the groups will receive Noradrenaline infusion if MAP <70 mmHg with optimal fluid transfusion .Target for transfusing Packed red blood cells will be value of haematocrit < 24 Postoperative HR, MAP, I/O-charting, Serum Creatinine, Serum Lactate, bowel sounds, Inotrope requirement, Visual Analogue Score, Ryles Tube Feeds, Epidural analgesia ,Length of stay (hours in SICU) and any postoperative complications shall be noted.
- Conditions
- Fluid Loss, Enhanced Recovery
- Being tested
- Goal directed Fluid Therapy, Conventional Fluid Therapy
- Keywords
- Goal Directed Fluid Therapy, Stroke volume variation, Enhanced recovery after surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal directed Fluid TherapyProcedure or surgery
Patients will receive fluid during surgery with goal of maintaining SVV below 11
Conventional Fluid TherapyProcedure or surgery
Patients will receive fluid during surgery with goal of maintaining CVP between 8-12 cms H20
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative Goal Directed Fluid Therapy (GDFT) guided by Stroke Volume Variation (SVV) | Active comparator | When SVV values will increase above 11 colloid bolus 200ml will be administered. postbolus change in values of SVV , SV , SVI and CI shall be noted. Receives: Procedure: Goal directed Fluid Therapy |
| Intraoperative Conventional Fluid Therapy (CFT) guided by Central Venous Pressure (CVP) . | Active comparator | When CVP values will decrease below 8 cmsH20 colloid bolus 200ml will be administered .Postbolus change in values shall be noted . Receives: Procedure: Conventional Fluid Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of ICU stay
Time of shifting of patients in both group to the ward in hours.
Measured: upto 5 days .
Postoperative serum Lactate levels mmol/L
Serum lactate levels will be measured in the SICU
Measured: upto 48 hours
Secondary outcomes (1)
Serum Creatinine levels mg/dL.
Serum Creatinine levels will be measured in the SICU .
Measured: Upto 48 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start13 Jul 2023
- Primary completion19 Jan 2024
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fluid LossStudies 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
- Patients in Conventional Group will be given intraoperative fluids guided by CVP Values . Patients in GDFT Group will be given fluids guided by SVV values.
- 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 and Research Centre , Delhi , India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026475
- Sponsor's protocol ID
- RGCIRC-GDFT
- Acronym
- GDFT ERAS
- Status last verified
- Mar 2024
- First submitted
- 29 Jul 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chong MA, Wang Y, Berbenetz NM, McConachie I. Does goal-directed haemodynamic and fluid therapy improve peri-operative outcomes?: A systematic review and meta-analysis. Eur J Anaesthesiol. 2018 Jul;35(7):469-483. doi: 10.1097/EJA.0000000000000778.
PubMed 29369117
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
- Role of Goal Directed Fluid Therapy in Enhanced Recovery After Surgery in Gastro-intestinal Onco-surgeries
- ClinicalTrials.gov ID
- NCT06026475
- Acronym / sponsor ID
- GDFT ERAS / RGCIRC-GDFT
- Conditions
- Fluid Loss, Enhanced Recovery
- Keywords
- Goal Directed Fluid Therapy, Stroke volume variation, Enhanced recovery after surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Rajiv Gandhi Cancer Institute & Research Center, IndiaUniversity, hospital or other
- Study start
- 13 Jul 2023 (actual)
- Primary completion
- 19 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 7 Sep 2023 (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.
Enhanced recovery after surgery (ERAS) protocols are multimodal perioperative care pathways designed to achieve early recovery and reducing postoperative morbidity after surgical procedures by maintaining preoperative organ function and reducing the profound stress response following surgery .The key elements of ERAS protocols include preoperative counselling, optimization of nutrition, standardized analgesic and anesthetic regimens , goal directed fluid therapy early mobilization.
Detailed description
For the proposed study investigators plan to include total 60 patients with 30 each allotted to GDFT(SVV) and CVP Group ,belonging to ASA ( American Society of Anesthesiology)Grade I/II/III, study will be conducted after obtaining written informed consent from all patients and approval from the scientific committee and Institutional Review Board (IRB). All patients will receive one-third starvation fluid as crystalloid during first hour of surgery . Night prior to and on the day of surgery carbo load will be given to all patients according to the protocol.Monitoring included 5 lead ECG SPO2,ETCO2, Invasive Blood Pressure (IBP - Radial),CVP(site IJV),core Temperature .
Standard General anaesthesia with oral Endotracheal tube and Intermittent Positive Pressure Ventilation will be given to all patients.Patients will be allotted randomly to either Goal Directed Fluid Therapy (GDFT) /SVV - Stroke Volume Variation or Conventional Central Venous Pressure - CVP guided fluid Therapy Group.
During the surgery - Heart rate , Mean arterial Blood Pressure , Urine output , Blood loss , Seum lactate levels will be noted.
For SVV Group - SVV , Stroke Volume Index (SVI) , Systemic vascular resistance index (SVRI) ,Cardiac Index (CI) values will be noted every 30 minutes- the goal is to maintain SVV value >11 and to give colloid bolus 200ml whenever SVV values rise above11.Pre and post bolus SVV, SV, SVI and SVRI shall be recorded.
For CVP Group - Goal is to maintain CVP values between 8-12 cmsH20 and for decrease in value < 8 colloid bolus of 200ml will be given and change in CVP value will be noted.
Patients in both the groups will receive Noradrenaline infusion if MAP <70 mmHg with optimal fluid transfusion .Target for transfusing Packed red blood cells will be value of haematocrit < 24 Postoperative HR, MAP, I/O-charting, Serum Creatinine, Serum Lactate, bowel sounds, Inotrope requirement, Visual Analogue Score, Ryles Tube Feeds, Epidural analgesia ,Length of stay (hours in SICU) and any postoperative complications shall be noted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients in Conventional Group will be given intraoperative fluids guided by CVP Values . Patients in GDFT Group will be given fluids guided by SVV values.
| Arm | Type | Receives |
|---|---|---|
| Intraoperative Goal Directed Fluid Therapy (GDFT) guided by Stroke Volume Variation (SVV) | Active comparator | Procedure: Goal directed Fluid TherapyWhen SVV values will increase above 11 colloid bolus 200ml will be administered. postbolus change in values of SVV , SV , SVI and CI shall be noted. |
| Intraoperative Conventional Fluid Therapy (CFT) guided by Central Venous Pressure (CVP) . | Active comparator | Procedure: Conventional Fluid TherapyWhen CVP values will decrease below 8 cmsH20 colloid bolus 200ml will be administered .Postbolus change in values shall be noted . |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective major open gastrointestinal Oncosurgeries .
Key exclusion criteria (4 listed)
- Patient refusal.
- Robotic surgery.
- Laparoscopic surgery.
- Arrythmias.
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 |
|---|---|---|
| Goal directed Fluid TherapyPatients will receive fluid during surgery with goal of maintaining SVV below 11 | Procedure or surgery | Intraoperative Goal Directed Fluid Therapy (GDFT) guided by Stroke Volume Variation (SVV) |
| Conventional Fluid TherapyPatients will receive fluid during surgery with goal of maintaining CVP between 8-12 cms H20 | Procedure or surgery | Intraoperative Conventional Fluid Therapy (CFT) guided by Central Venous Pressure (CVP) . |
Primary outcome
Duration of ICU stay
Time frame: upto 5 days .
Time of shifting of patients in both group to the ward in hours.
Postoperative serum Lactate levels mmol/L
Time frame: upto 48 hours
Serum lactate levels will be measured in the SICU
1 secondary outcome
Serum Creatinine levels mg/dL.
Time frame: Upto 48 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.
- Background: PubMed 29369117Chong MA, Wang Y, Berbenetz NM, McConachie I. Does goal-directed haemodynamic and fluid therapy improve peri-operative outcomes?: A systematic review and meta-analysis. Eur J Anaesthesiol. 2018 Jul;35(7):469-483. doi: 10.1097/EJA.0000000000000778.
- 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 and Research Centre , Delhi , 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 Goal directed Fluid Therapy and Conventional Fluid Therapy in people with Fluid Loss and Enhanced Recovery, 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 4 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?
Duration of ICU stay (time frame: upto 5 days .). 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 NCT06026475, which also lists 1 linked publication.
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.