Spine DiseaseNCT03164811
GDFT Based on PPV Compared With Standard Fluid Therapy in Patients Undergoing Complex Spine Surgery: RCT
A study testing goal directed fluid therapy in people with Spine Disease, run by Mahidol University at 1 site in Thailand.
Trial summary
The investigators will do the Goal directed fluid therapy by protocolized fluid management in the experimental group, using PPV to guide the fluid administration, compare with standard fluid management in patients undergoing complex spine surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spine Disease
- What is being tested?
- goal directed 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 siteThailand
- Study dates
- 11 Apr 2017to 30 Jan 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1-3
- elective surgery
- thoracic/lumbar spine surgery >= 3 levels and duration >= 3 hours
Who cannot join
- Cr >2 mg/dl or eGFR < 60 ml/min
- coronary artery disease, congestive heart failure or cardiac arrhythmia
- BMI >30 kg/m2
- hemodynamic unstable, preoperatively
- uncontrolled hypertension
- respiratory system compliance < 30 ml/cmH2O
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Siriraj Hospital
Bangkok Noi, Bangkok, 10700
About this study
Official title: Goal Directed Fluid Therapy Based on Pulse Pressure Variation Compared With Standard Fluid Therapy in Patients Undergoing Complex Spine Surgery: a Randomized Controlled Trial
The investigators will do the Goal directed fluid therapy by protocolized fluid management in the experimental group, using PPV to guide the fluid administration, compare with standard fluid management in patients undergoing complex spine surgery.
- Conditions
- Spine Disease
- Being tested
- goal directed fluid therapy, Controlled
- Medical subject headings
- Spinal Diseases
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
pulse pressure variation will be used to as a goal to guide fluid administration in this group
ControlledOther
standard fluid treatment by an anesthesiologist
| Study group | Role | What they receive |
|---|---|---|
| GDFT group | Experimental | The GDFT group will receive 400 ml of 12.5% carbohydrate drink after 6 pm until the bed time in the day before surgery and 200 ml in the morning of the surgery day. Acetate ringer solution will be start at 7:00. After induction PPV will be measure and fluid bolus 200 ml in 10 minutes will be given if PPV >13 before prone position. During the operation, the patient in GDFT group will receipt fluid therapy according to acceptable PPV Receives: Procedure: goal directed fluid therapy |
| controlled group | Other | The carbohydrate drink will not be given. Fluid, blood and blood product administration will be under attending anesthesiologist order. Receives: Other: Controlled |
What is being measured
The primary outcome is the main question the study is designed to answer.
episode of intraoperative hypotension
Blood pressure will be record continuously using arterial catheter in both group. Number of participants and episode of hypotension (defined as SBP < 90 mmHg or MAP < 60 mmHg or decrease of SPB >= 25% from baseline for 5 minutes or need vasopressor) therapy
Measured: intraoperative
Secondary outcomes (1)
unit of blood transfusion
all unit of blood transfusion will be record intraoperative and postoperative
Measured: intraoperative and up to 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start11 Apr 2017
- Primary completion30 Dec 2018
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine DiseaseStudies 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
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164811
- Sponsor's protocol ID
- Si826/2016
- Status last verified
- Feb 2020
- First submitted
- 24 Apr 2017
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goal Directed Fluid Therapy Based on Pulse Pressure Variation Compared With Standard Fluid Therapy in Patients Undergoing Complex Spine Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03164811
- Acronym / sponsor ID
- Si826/2016
- Conditions
- Spine Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 24 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.
The investigators will do the Goal directed fluid therapy by protocolized fluid management in the experimental group, using PPV to guide the fluid administration, compare with standard fluid management in patients undergoing complex spine surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GDFT group | Experimental | Procedure: goal directed fluid therapyThe GDFT group will receive 400 ml of 12.5% carbohydrate drink after 6 pm until the bed time in the day before surgery and 200 ml in the morning of the surgery day. Acetate ringer solution will be start at 7:00. After induction PPV will be measure and fluid bolus 200 ml in 10 minutes will be given if PPV >13 before prone position. During the operation, the patient in GDFT group will receipt fluid therapy according to acceptable PPV |
| controlled group | Other | Other: ControlledThe carbohydrate drink will not be given. Fluid, blood and blood product administration will be under attending anesthesiologist order. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA 1-3
- elective surgery
- thoracic/lumbar spine surgery >= 3 levels and duration >= 3 hours
Key exclusion criteria (6 listed)
- Cr >2 mg/dl or eGFR < 60 ml/min
- coronary artery disease, congestive heart failure or cardiac arrhythmia
- BMI >30 kg/m2
- hemodynamic unstable, preoperatively
- uncontrolled hypertension
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 therapypulse pressure variation will be used to as a goal to guide fluid administration in this group | Procedure or surgery | GDFT group |
| Controlledstandard fluid treatment by an anesthesiologist | Other | controlled group |
Primary outcome
episode of intraoperative hypotension
Time frame: intraoperative
Blood pressure will be record continuously using arterial catheter in both group. Number of participants and episode of hypotension (defined as SBP < 90 mmHg or MAP < 60 mmHg or decrease of SPB >= 25% from baseline for 5 minutes or need vasopressor) therapy
1 secondary outcome
unit of blood transfusion
Time frame: intraoperative and up to 24 hours postoperatively
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 Feb 2020.
- 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 goal directed fluid therapy in people with Spine Disease, run by Mahidol University at 1 site in Thailand.
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 3 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 Feb 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 Thailand. 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?
episode of intraoperative hypotension (time frame: intraoperative). 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 Feb 2020.