AnesthesiaNCT06133257
Goal-Directed Fluid Therapy in Patients Undergoing Lower Limb Surgeries
A study testing Goal-Directed Fluid Therapy guided by Inferior Vena Cava Collapsibility Index and standard fluid management in people with Anesthesia and ERAS, run by Zagazig University.
Trial summary
Controlling the amount of fluids given to patients in perioperative setting can significantly influence their outcomes. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, ERAS, Fluid Overload
- What is being tested?
- Goal-Directed Fluid Therapy guided by Inferior Vena Cava Collapsibility Index and standard fluid management
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 1 Aug 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient's acceptance.
- Patients planned for elective lower limb surgery under spinal anesthesia.
- Both sexes
- Body Mass Index(BMI): <35
- Age: 21 ~ 65 years
- American Society of Anesthesiologists(ASA) Physical Status Classification System: Class I \& II
- Duration of surgery 2~3 hours
Who cannot join
- Advanced kidney, liver, respiratory or cardiovascular disease.
- Contraindication for spinal anesthesia.
- Patients shifted to general anesthesia for any reason.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Goal-Directed Fluid Therapy Guided by Inferior Vena Cava Collapsibility Index on Hemodynamics and Enhanced Recovery in Patients Undergoing Lower Limb Surgeries
Controlling the amount of fluids given to patients in perioperative setting can significantly influence their outcomes.
Read the detailed description
To overcome these problems and avoid the complications of over or underhydration, we use the Goal-directed fluid therapy(GDFT) guided by Inferior vena cava(IVC) collapsibility index approach in which dynamic parameters of volume responsiveness as a guide for fluid therapy. This will ensure that the fluids given were deficient from the circulation and improve the recovery of the patients according to enhanced recovery after surgery(ERAS) protocols.
- Conditions
- Anesthesia, ERAS, Fluid Overload, Hypovolemia; Surgical Shock
- Being tested
- Goal-Directed Fluid Therapy guided by Inferior Vena Cava Collapsibility Index, standard fluid management
- Medical subject headings
- Edema, Hypovolemia, Shock, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal-Directed Fluid Therapy guided by Inferior Vena Cava Collapsibility IndexProcedure or surgery
Measuring Inferior vena cava(IVC) diameter using ultrasound then calculation Inferior vena cava(IVC) collapsibility index and administer fluid accordingly.
standard fluid managementProcedure or surgery
standard fluid management
| Study group | Role | What they receive |
|---|---|---|
| GD Group | Active comparator | Patients will take oral clear fluids with carbohydrates content 2 hours preoperatively and intraoperative fluid intake will be guided by Inferior vena cava(IVC) diameter. Receives: Procedure: Goal-Directed Fluid Therapy guided by Inferior Vena Cava Collapsibility Index |
| C Group | Active comparator | the standard fluid management group patients will be fasting 6 hours preoperatively and will receive intraoperative fluid in standard manner. Receives: Procedure: standard fluid management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Arterial Blood Pressure
intraoperative mean arterial blood pressure measured in mmHg
Measured: intraoperatively every 5 minutes
Quality of Recovery-40 score(QoR-40)
QoR-40 score ranges from 40 to 200, the higher the score the better the outcome
Measured: 24 hours postoperative
Heart Rate
intraoperative heart rate will be continuously monitored and recorded every 5 minutes
Measured: intraoperatively every 5 minutes
Post Anesthesia Care Unit(PACU) Stay
time spent in PACU after surgery measured in minutes
Measured: 2 hours postoperatively
Secondary outcomes (4)
Total fluid intake during operation
Total fluid intake during operation
Measured: intraoperatively
Number of patients that needed Ephedrine or Atropine
Number of patients that needed Ephedrine or Atropine intraoperatively
Measured: intraoperatively
Peripheral perfusion index
Peripheral Perfusion Index (PPI) is defined as "the ratio of pulsatile blood flow to the non-pulsatile blood flow". It ranges from 0.02% to 20% and it is measured using specific types pulse oximetry and it reflects the perfusion status of the body.
Measured: Intraoperatively
Length of hospital stay
the number of days from day of surgery until patient's discharge from hospital
Measured: the patient will be followed up for 60 days from day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mahmoud Aboubakr Abdelkader, Zagazig University
- Investigators
- Mahmoud Abdelkader, MBBCh, Principal investigator, Anesthesia, Intensive Care and Pain Management department, Faculty of Medicine, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133257
- Sponsor's protocol ID
- 11122
- Status last verified
- Nov 2023
- First submitted
- 31 Oct 2023
- Last updated
- 15 Nov 2023
- 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 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Goal-Directed Fluid Therapy Guided by Inferior Vena Cava Collapsibility Index on Hemodynamics and Enhanced Recovery in Patients Undergoing Lower Limb Surgeries
- ClinicalTrials.gov ID
- NCT06133257
- Acronym / sponsor ID
- 11122
- Conditions
- Anesthesia, ERAS, Fluid Overload, Hypovolemia; Surgical Shock
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 15 Nov 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.
Controlling the amount of fluids given to patients in perioperative setting can significantly influence their outcomes.
Detailed description
To overcome these problems and avoid the complications of over or underhydration, we use the Goal-directed fluid therapy(GDFT) guided by Inferior vena cava(IVC) collapsibility index approach in which dynamic parameters of volume responsiveness as a guide for fluid therapy. This will ensure that the fluids given were deficient from the circulation and improve the recovery of the patients according to enhanced recovery after surgery(ERAS) protocols.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GD Group | Active comparator | Procedure: Goal-Directed Fluid Therapy guided by Inferior Vena Cava Collapsibility IndexPatients will take oral clear fluids with carbohydrates content 2 hours preoperatively and intraoperative fluid intake will be guided by Inferior vena cava(IVC) diameter. |
| C Group | Active comparator | Procedure: standard fluid managementthe standard fluid management group patients will be fasting 6 hours preoperatively and will receive intraoperative fluid in standard manner. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient's acceptance.
- Patients planned for elective lower limb surgery under spinal anesthesia.
- Both sexes
- Body Mass Index(BMI): <35
- Age: 21 ~ 65 years
Key exclusion criteria (3 listed)
- Advanced kidney, liver, respiratory or cardiovascular disease.
- Contraindication for spinal anesthesia.
- Patients shifted to general anesthesia for any reason.
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 Therapy guided by Inferior Vena Cava Collapsibility IndexMeasuring Inferior vena cava(IVC) diameter using ultrasound then calculation Inferior vena cava(IVC) collapsibility index and administer fluid accordingly. | Procedure or surgery | GD Group |
| standard fluid managementstandard fluid management | Procedure or surgery | C Group |
Primary outcome
Mean Arterial Blood Pressure
Time frame: intraoperatively every 5 minutes
intraoperative mean arterial blood pressure measured in mmHg
Quality of Recovery-40 score(QoR-40)
Time frame: 24 hours postoperative
QoR-40 score ranges from 40 to 200, the higher the score the better the outcome
Heart Rate
Time frame: intraoperatively every 5 minutes
intraoperative heart rate will be continuously monitored and recorded every 5 minutes
Post Anesthesia Care Unit(PACU) Stay
Time frame: 2 hours postoperatively
time spent in PACU after surgery measured in minutes
4 secondary outcomes
Total fluid intake during operation
Time frame: intraoperatively
Number of patients that needed Ephedrine or Atropine
Time frame: intraoperatively
Peripheral perfusion index
Time frame: Intraoperatively
Length of hospital stay
Time frame: the patient will be followed up for 60 days from day of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- 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.
Mahmoud Abdelkader, MBBCh principal investigator
Anesthesia, Intensive Care and Pain Management department, Faculty of Medicine, Zagazig University
Questions about this trial
What is this clinical trial studying?
A study testing Goal-Directed Fluid Therapy guided by Inferior Vena Cava Collapsibility Index and standard fluid management in people with Anesthesia and ERAS, run by Zagazig University.
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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Abdelkader, MBBCh (00201553638376, mahmoud.ab.ali@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Arterial Blood Pressure (time frame: intraoperatively every 5 minutes). The study lists 4 primary outcomes in all. 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 15 Nov 2023.