Cut-Off ValueNCT07174128
Two Cut-Off Values of Plethysmographic Variability Index to Guide Intraoperative Fluid Therapy on Serum Lactate in Patients Undergoing Excision of Supra-Tentorial Brain Tumors
A study testing Fluid Therapy in people with Cut-Off Value and Plethysmographic Variability Index, run by Cairo University at 1 site in Egypt.
Trial summary
This study aimed to compare two cut-off values of plethysmographic variability index (PVI) -guided fluid therapy in patients undergoing supra-tentorial mass excision regarding immediate postoperative serum lactate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cut-Off Value, Plethysmographic Variability Index, Intraoperative
- What is being tested?
- Fluid Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Sep 2025to 24 Feb 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 18 years old.
- Both sexes.
- Patients scheduled for supra-tentorial brain tumor excision.
Who cannot join
- Arrhythmias.
- Pulmonary hypertension.
- Impaired cardiac contractility.
- Impaired liver or kidney function.
- Low lung compliance.
- Body mass index above 40.
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- Intra-operative hemodynamic instability on vasopressors or inotropes.
- Peripheral arterial occlusive diseases.
- Hand injuries or burns that preclude the application of the Masimo device probe.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Two Cut-Off Values of Plethysmographic Variability Index to Guide Intraoperative Fluid Therapy on Serum Lactate in Patients Undergoing Excision of Supra-Tentorial Brain Tumors: A Randomized Controlled Study
This study aimed to compare two cut-off values of plethysmographic variability index (PVI) -guided fluid therapy in patients undergoing supra-tentorial mass excision regarding immediate postoperative serum lactate.
Read the detailed description
Fluid therapy in patients undergoing craniotomy is very critical; hypovolemia might decrease cerebral perfusion, while fluid overinfusion might cause brain swelling that impairs surgical removal of lesions.
The plethysmographic variability index (PVI) is one of the dynamic indices of fluid responsiveness, a simple, automatic, non-invasive, and continuous method based on calculating changes in the perfusion index (PI).
- Conditions
- Cut-Off Value, Plethysmographic Variability Index, Intraoperative, Fluid Therapy, Serum Lactate, Excision
- Being tested
- Fluid Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid TherapyOther
Patients would receive the second round of fluid loading if the Plethysmographic Variability Index (PVI) was 14%.
Fluid TherapyOther
Patients would receive the second round of fluid loading if the Plethysmographic Variability Index (PVI) was 20%.
| Study group | Role | What they receive |
|---|---|---|
| Low PVI group | Experimental | Patients would receive the second round of fluid loading if the Plethysmographic Variability Index (PVI) was 14%. Receives: Other: Fluid Therapy |
| High PVI gro | Experimental | Patients would receive the second round of fluid loading if the Plethysmographic Variability Index (PVI) was 20%. Receives: Other: Fluid Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum lactate level
Serum lactate level was measured at the end of surgery (immediately after extubation).
Measured: 24 hours postoperatively
Secondary outcomes (4)
Brain Relaxation scale
The neurosurgeon assessed the Brain Relaxation scale at three time intervals: with dural opening, after two hours, and before dural closure. A 4-point scale will be performed as follows: grade 1, perfectly relaxed; grade 2, satisfactorily relaxed; grade 3, firm brain; grade 4, bulging brain.
Measured: Intraoperatively
Heart rate
Heart rate was measured immediately after fluid loading and every 5 minutes for 20 minutes.
Measured: 20 minutes after fluid loading
Mean arterial pressure
Mean arterial pressure was measured immediately after fluid loading and every 5 minutes for 20 minutes.
Measured: 20 minutes after fluid loading
Length of hospital stay
Length of hospital stay was recorded from admission till discharge from the hospital.
Measured: Till discharge from the hospital (Up to 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start20 Sep 2025
- Primary completion24 Feb 2026
- Study completion24 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cut-Off ValueStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Gomaa Abdelhameed Eltokhy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174128
- Sponsor's protocol ID
- MD--452-2023
- Status last verified
- Apr 2026
- First submitted
- 4 Sep 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Two Cut-Off Values of Plethysmographic Variability Index to Guide Intraoperative Fluid Therapy on Serum Lactate in Patients Undergoing Excision of Supra-Tentorial Brain Tumors: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07174128
- Acronym / sponsor ID
- MD--452-2023
- Conditions
- Cut-Off Value, Plethysmographic Variability Index, Intraoperative, Fluid Therapy, Serum Lactate, Excision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Sep 2025 (actual)
- Primary completion
- 24 Feb 2026 (actual)
- Study completion
- 24 Feb 2026 (actual)
- First posted
- 15 Sep 2025 (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.
This study aimed to compare two cut-off values of plethysmographic variability index (PVI) -guided fluid therapy in patients undergoing supra-tentorial mass excision regarding immediate postoperative serum lactate.
Detailed description
Fluid therapy in patients undergoing craniotomy is very critical; hypovolemia might decrease cerebral perfusion, while fluid overinfusion might cause brain swelling that impairs surgical removal of lesions.
The plethysmographic variability index (PVI) is one of the dynamic indices of fluid responsiveness, a simple, automatic, non-invasive, and continuous method based on calculating changes in the perfusion index (PI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low PVI group | Experimental | Other: Fluid TherapyPatients would receive the second round of fluid loading if the Plethysmographic Variability Index (PVI) was 14%. |
| High PVI gro | Experimental | Other: Fluid TherapyPatients would receive the second round of fluid loading if the Plethysmographic Variability Index (PVI) was 20%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age above 18 years old.
- Both sexes.
- Patients scheduled for supra-tentorial brain tumor excision.
Key exclusion criteria (9 listed)
- Arrhythmias.
- Pulmonary hypertension.
- Impaired cardiac contractility.
- Impaired liver or kidney function.
- Low lung compliance.
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 |
|---|---|---|
| Fluid TherapyPatients would receive the second round of fluid loading if the Plethysmographic Variability Index (PVI) was 14%. | Other | Low PVI group |
| Fluid TherapyPatients would receive the second round of fluid loading if the Plethysmographic Variability Index (PVI) was 20%. | Other | High PVI gro |
Primary outcome
Serum lactate level
Time frame: 24 hours postoperatively
Serum lactate level was measured at the end of surgery (immediately after extubation).
4 secondary outcomes
Brain Relaxation scale
Time frame: Intraoperatively
Heart rate
Time frame: 20 minutes after fluid loading
Mean arterial pressure
Time frame: 20 minutes after fluid loading
Length of hospital stay
Time frame: Till discharge from the hospital (Up to 2 weeks)
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 21 Apr 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 Fluid Therapy in people with Cut-Off Value and Plethysmographic Variability Index, run by Cairo University at 1 site in Egypt.
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 9 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 21 Apr 2026. 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 Egypt. 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?
Serum lactate level (time frame: 24 hours postoperatively). 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 21 Apr 2026.