Fluid Hypovolemia, CerebrospinalNCT05076929
Assessment of Ultrasonographic Measurement of Inferior Vena Cava Collapsibility Index in Prediction of Hypotension Associated With Tourniquet Release in Total Knee Replacement Surgeries Under Spinal Anesthesia
An observational study of Fluid Hypovolemia, Cerebrospinal, run by Ain Shams University at 1 site in Egypt.
Trial summary
Administration of intravascular fluids is one of the methods to prevent SA-induced hypotension, but empirical intraoperative volume repletion carries the risk of fluid overload during elective surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fluid Hypovolemia, Cerebrospinal
- What is being tested?
- ultrasound
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 28 May 2021to 1 Mar 2022
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Total Knee Replacement Surgeries under Spinal Anesthesia
Who may be able to join
- ASA grade I, II, III
- Age 18 -65 yrs
- Spinal Anesthesia
Who cannot join
- Patient refusal
- Patient having contraindication of Spinal Anesthesia (infection at the site of injection, spine deformity, coagulation disorders ) .
- Known cardiac, renal, neurological, metabolic, endocrine, psychiatric, respiratory disease.
Trial locations and contacts
1 site in 1 country.
About this study
Administration of intravascular fluids is one of the methods to prevent SA-induced hypotension, but empirical intraoperative volume repletion carries the risk of fluid overload during elective surgery. Over fluid resuscitation is associated with organ dysfunction and higher mortality rate , thus, to avoid ineffective or even harmful intravascular volume expansion, it is important to have tools to predict hypotension and fluid responsiveness.
- Conditions
- Fluid Hypovolemia, Cerebrospinal
- Being tested
- ultrasound
- Medical subject headings
- Intracranial Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDiagnostic test
Ultrasonographic measurement of Inferior Vena Cava Collapsibility Index
What is being measured
The primary outcome is the main question the study is designed to answer.
mean arterial blood pressure
Measured: 15 minutes after tourniquet release
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start28 May 2021
- Primary completion1 Feb 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid Hypovolemia, CerebrospinalStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Ammar, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05076929
- Sponsor's protocol ID
- MS 292/ 2021
- Status last verified
- Sep 2022
- First submitted
- 26 Sep 2021
- Last updated
- 3 Oct 2022
- Results posted
- 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 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Ultrasonographic Measurement of Inferior Vena Cava Collapsibility Index in Prediction of Hypotension Associated With Tourniquet Release in Total Knee Replacement Surgeries Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT05076929
- Acronym / sponsor ID
- MS 292/ 2021
- Conditions
- Fluid Hypovolemia, Cerebrospinal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 28 May 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 13 Oct 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.
Administration of intravascular fluids is one of the methods to prevent SA-induced hypotension, but empirical intraoperative volume repletion carries the risk of fluid overload during elective surgery. Over fluid resuscitation is associated with organ dysfunction and higher mortality rate , thus, to avoid ineffective or even harmful intravascular volume expansion, it is important to have tools to predict hypotension and fluid responsiveness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Total Knee Replacement Surgeries under Spinal Anesthesia
Key inclusion criteria (3 listed)
- ASA grade I, II, III
- Age 18 -65 yrs
- Spinal Anesthesia
Key exclusion criteria (3 listed)
- Patient refusal
- Patient having contraindication of Spinal Anesthesia (infection at the site of injection, spine deformity, coagulation disorders ) .
- Known cardiac, renal, neurological, metabolic, endocrine, psychiatric, respiratory 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 |
|---|---|---|
| ultrasoundUltrasonographic measurement of Inferior Vena Cava Collapsibility Index | Diagnostic test | – |
Primary outcome
mean arterial blood pressure
Time frame: 15 minutes after tourniquet release
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 3 Oct 2022.
- Individual participant dataSharing planned: No
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?
An observational study of Fluid Hypovolemia, Cerebrospinal, run by Ain Shams 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 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: finished, as of the sponsor's last update on 3 Oct 2022. 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?
mean arterial blood pressure (time frame: 15 minutes after tourniquet release). 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 3 Oct 2022.