Monitoring During AnesthesiaNCT03391037
Internal Jugular Vein Distensibility in Assessment of Fluid Responsiveness in Donors of Living Donor Liver Transplantation
An observational study of Monitoring During Anesthesia, run by Ain Shams University.
Trial summary
Egypt has a very high prevalence of HCV and a high morbidity and mortality from chronic liver disease, cirrhosis, and hepatocellular carcinoma. Approximately 20% of Egyptian blood donors are anti-HCV positive. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Monitoring During Anesthesia
- What is being tested?
- Internal Jugular Vein Distensibility
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to 1 Oct 2017
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Prospective blinded observational study
Who may be able to join
- age of 20 years . candidate for donor right lobe hepatectomy for LDLT . volume assessment diagnosed as hypovolemia intraopertively by the anesthesiologist.
Who cannot join
- inability to scan IJV secondary to surgical dressing, hematoma formation after trial or placement of CVP catheter on left side.
- inability for proper positioning.
About this study
Egypt has a very high prevalence of HCV and a high morbidity and mortality from chronic liver disease, cirrhosis, and hepatocellular carcinoma. Approximately 20% of Egyptian blood donors are anti-HCV positive. Egypt has higher rates of HCV than neighboring countries as well as other countries in the world with comparable socioeconomic conditions and hygienic standards for invasive medical, dental, or paramedical procedures.
Donor safety is on the top of our priorities as a team and it is widely recognized intraopertively during hepatectomy, there are several potential risks during the Perioperative period .
Read the detailed description
to a conclusion that intraoperative fluid management aids to the reduction of the intraoperative bleeding during the procedure, adequate and guided fluid management is considered one of the important strategies to reduce the blood loss besides of the other anesthetic techniques like hemodilution, normovolemia, cell salvage usage , high Stroke volume variation (SVV) method ,and low CVP technique , the last method is considered the most applicable, simpler, and cost effective technique which could be easier to be performed.
- Conditions
- Monitoring During Anesthesia
- Being tested
- Internal Jugular Vein Distensibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internal Jugular Vein DistensibilityDiagnostic test
. 40 donor candidates for right lobe hepatectomy for living donor liver transplantation were enrolled. During period of hypovolemia (T0) left IJV scanned and measured. After a given fluid bolus in the form of ringer acetate 5 ml / Kg. ultrasonic and hemodynamic measurements were reassessed 10 minutes (T 10) after the fluid resuscitation
| Study group | Role | What they receive |
|---|---|---|
| Intervention | diagnostic criteria for volume assessment were heart rate (HR), mean arterial blood pressure (MABP), central venous pressure (CVP), and urine output hourly (UOP) in ml/hr. During period of hypovolemia, all enrolled patients had left IJV scanned (T0) and measured by one anesthesiologist experienced in point-of-care ultrasound. This point-of-care anesthesiologist is not involved in the anesthetic management of the patient and blinded to the volume status of the patient values. Hypovolemic patients were given a fluid bolus in the form of ringer acetate 5 ml / Kg. Ultrasonic and hemodynamic measurements are reassessed 10 minutes (T 10) after the fluid resuscitation. Receives: Diagnostic Test: Internal Jugular Vein Distensibility |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between CVP and IJV distensibility
IJV distensibility is the difference between maximum diameter of IJV and minimum diamter in Manchester mode divided by minimum diameter
Measured: 10 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study startNov 2016
- Primary completion10 Aug 2017
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monitoring During AnesthesiaStudies 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
- 40 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
- NCT03391037
- Sponsor's protocol ID
- 133/2018
- Status last verified
- Dec 2017
- First submitted
- 22 Dec 2017
- Last updated
- 5 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internal Jugular Vein Distensibility in Assessment of Fluid Responsiveness in Donors of Living Donor Liver Transplantation
- ClinicalTrials.gov ID
- NCT03391037
- Acronym / sponsor ID
- 133/2018
- Conditions
- Monitoring During Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- 10 Aug 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 5 Jan 2018 (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.
Egypt has a very high prevalence of HCV and a high morbidity and mortality from chronic liver disease, cirrhosis, and hepatocellular carcinoma. Approximately 20% of Egyptian blood donors are anti-HCV positive. Egypt has higher rates of HCV than neighboring countries as well as other countries in the world with comparable socioeconomic conditions and hygienic standards for invasive medical, dental, or paramedical procedures.
Donor safety is on the top of our priorities as a team and it is widely recognized intraopertively during hepatectomy, there are several potential risks during the Perioperative period .
Detailed description
to a conclusion that intraoperative fluid management aids to the reduction of the intraoperative bleeding during the procedure, adequate and guided fluid management is considered one of the important strategies to reduce the blood loss besides of the other anesthetic techniques like hemodilution, normovolemia, cell salvage usage , high Stroke volume variation (SVV) method ,and low CVP technique , the last method is considered the most applicable, simpler, and cost effective technique which could be easier to be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Diagnostic Test: Internal Jugular Vein Distensibilitydiagnostic criteria for volume assessment were heart rate (HR), mean arterial blood pressure (MABP), central venous pressure (CVP), and urine output hourly (UOP) in ml/hr. During period of hypovolemia, all enrolled patients had left IJV scanned (T0) and measured by one anesthesiologist experienced in point-of-care ultrasound. This point-of-care anesthesiologist is not involved in the anesthetic management of the patient and blinded to the volume status of the patient values. Hypovolemic patients were given a fluid bolus in the form of ringer acetate 5 ml / Kg. Ultrasonic and hemodynamic measurements are reassessed 10 minutes (T 10) after the fluid resuscitation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Prospective blinded observational study
Key inclusion criteria (1 listed)
- age of 20 years . candidate for donor right lobe hepatectomy for LDLT . volume assessment diagnosed as hypovolemia intraopertively by the anesthesiologist.
Key exclusion criteria (2 listed)
- inability to scan IJV secondary to surgical dressing, hematoma formation after trial or placement of CVP catheter on left side.
- inability for proper positioning.
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 |
|---|---|---|
| Internal Jugular Vein Distensibility. 40 donor candidates for right lobe hepatectomy for living donor liver transplantation were enrolled. During period of hypovolemia (T0) left IJV scanned and measured. After a given fluid bolus in the form of ringer acetate 5 ml / Kg. ultrasonic and hemodynamic measurements were reassessed 10 minutes (T 10) after the fluid resuscitation | Diagnostic test | Intervention |
Primary outcome
correlation between CVP and IJV distensibility
Time frame: 10 min
IJV distensibility is the difference between maximum diameter of IJV and minimum diamter in Manchester mode divided by minimum diameter
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 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Monitoring During Anesthesia, run by Ain Shams 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 1 inclusion and 2 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 Jan 2018. 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?
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?
correlation between CVP and IJV distensibility (time frame: 10 min). 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 Jan 2018.