Fluid ResponseNCT03921125
Pleth Variability Index for Directed Fluid Optimization in Donors in Living Donor Liver Transplantation
An observational study of Fluid Response, run by Ain Shams University at 2 sites in Egypt.
Trial summary
In this Study we are trying to validate the accuracy of Plethogram variability index in predicting fluid responsiveness compared to pulse pressure variation in donors of liver transplantation Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Fluid Response
- What is being tested?
- Massimo for Pleth variability index
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 2 sitesEgypt
- Study dates
- 9 Oct 2018to 20 Oct 2019
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: Sample of 40 healthy ASA I or II donors' candidate for right lobe hepatectomy for living donor liver transplantation
Who may be able to join
- Sample of 40 healthy ASA I or II donors' candidate for right lobe hepatectomy for living donor liver transplantation
Who cannot join
- Lack of consent
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Ain Shams University Hospitals
Cairo
Fathy Tash, MD, +20226857539
Amr M Hilal Abdou, MD
- Recruiting
Ain shams university hospitals
Cairo
Amr M Hilal Abdou, MD
About this study
Official title: The Accuracy of Pleth Variability Index for Directed Fluid Optimization in Donors in Living Donor Liver Transplantation
In this Study we are trying to validate the accuracy of Plethogram variability index in predicting fluid responsiveness compared to pulse pressure variation in donors of liver transplantation
Read the detailed description
The liver transplantation program at Ain Shams University Hospitals relies on related living donors. Extra care during anesthetic management of the donor is warranted because of clear ethical considerations.
This prospective observational study was performed after obtaining approval from the ethical committee of the Ain Shams University FWA R 53/2018. Sample of 40 healthy ASA I or II donors' candidate for right lobe hepatectomy for living donor liver transplantation (LDLT) were included and consent was taken. Conventional form of anesthesia was induced with left radial arterial line inserted for invasive blood pressure monitoring, frequent blood gases and lactate sampling, and measuring the PPV, Right insertion of internal jugular vein line for CVP measurement. Fluid management in the form of ringer acetate 3-5 ml/kg/hr recruitment of the patients (Hypovolemic donors) depends on the presenting signs that led the anesthesiologist to decide if the patient's volume status was hypovolemic and in need for fluid replacement without presence of surgical mechanical compression on the IVC or Liver during dissection phase. These diagnostic criteria for volume assessment were heart rate (HR) more than 100 beats/min, systolic arterial blood pressure (SAP) less than 90 mmHg.
Assessment of Hemodynamics during periods of Hypovolemia After exclusion of any surgical mechanical compression, all enrolled hypovolemic patients had left radial arterial line measuring PPV using Drager Monitor and a pulse oximeter measuring PVI using Device Masimo. This device measures the perfusion index which is the indicator of the amplitude of the signal of PVI, confirmation of the wave signal should be obtained from any finger, fingers should be kept warm before test is done. Hypovolemic patients were given a fluid bolus in the form of ringer acetate 5 ml / Kg over 10 minutes. At the end of volume expansion another recorded PPV and PVI are done. Primary outcome was the correlation between PPV and PVI before and after fluid resuscitation
- Conditions
- Fluid Response
- Being tested
- Massimo for Pleth variability index
- Keywords
- Living donors, PVI, PPV, Fluids, Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massimo for Pleth variability indexDevice
To assess fluid response
| Study group | Role | What they receive |
|---|---|---|
| Responders | Not described Receives: Device: Massimo for Pleth variability index | |
| Non responders | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between PPV and PVI before and after fluid resuscitation.
Assess accuracy of device in fluid response
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start9 Oct 2018
- Primary completion20 Sep 2019 (estimated)
- Study completion20 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid ResponseStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr M Hilal Abdou, Ain Shams University
- Investigators
- Amr Hilal abdou, Principal investigator, Ain shams University, Faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03921125
- Sponsor's protocol ID
- R 53/2018
- Status last verified
- May 2019
- First submitted
- 17 Apr 2019
- Last updated
- 4 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Decided to share the IPD
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy of Pleth Variability Index for Directed Fluid Optimization in Donors in Living Donor Liver Transplantation
- ClinicalTrials.gov ID
- NCT03921125
- Acronym / sponsor ID
- R 53/2018
- Conditions
- Fluid Response
- Keywords
- Living donors, PVI, PPV, Fluids, Response
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 9 Oct 2018 (actual)
- Primary completion
- 20 Sep 2019 (estimated)
- Study completion
- 20 Oct 2019 (estimated)
- First posted
- 19 Apr 2019 (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.
In this Study we are trying to validate the accuracy of Plethogram variability index in predicting fluid responsiveness compared to pulse pressure variation in donors of liver transplantation
Detailed description
The liver transplantation program at Ain Shams University Hospitals relies on related living donors. Extra care during anesthetic management of the donor is warranted because of clear ethical considerations.
This prospective observational study was performed after obtaining approval from the ethical committee of the Ain Shams University FWA R 53/2018. Sample of 40 healthy ASA I or II donors' candidate for right lobe hepatectomy for living donor liver transplantation (LDLT) were included and consent was taken. Conventional form of anesthesia was induced with left radial arterial line inserted for invasive blood pressure monitoring, frequent blood gases and lactate sampling, and measuring the PPV, Right insertion of internal jugular vein line for CVP measurement. Fluid management in the form of ringer acetate 3-5 ml/kg/hr recruitment of the patients (Hypovolemic donors) depends on the presenting signs that led the anesthesiologist to decide if the patient's volume status was hypovolemic and in need for fluid replacement without presence of surgical mechanical compression on the IVC or Liver during dissection phase. These diagnostic criteria for volume assessment were heart rate (HR) more than 100 beats/min, systolic arterial blood pressure (SAP) less than 90 mmHg.
Assessment of Hemodynamics during periods of Hypovolemia After exclusion of any surgical mechanical compression, all enrolled hypovolemic patients had left radial arterial line measuring PPV using Drager Monitor and a pulse oximeter measuring PVI using Device Masimo. This device measures the perfusion index which is the indicator of the amplitude of the signal of PVI, confirmation of the wave signal should be obtained from any finger, fingers should be kept warm before test is done. Hypovolemic patients were given a fluid bolus in the form of ringer acetate 5 ml / Kg over 10 minutes. At the end of volume expansion another recorded PPV and PVI are done. Primary outcome was the correlation between PPV and PVI before and after fluid resuscitation
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Responders | – | Device: Massimo for Pleth variability index |
| Non responders | – | – |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Sample of 40 healthy ASA I or II donors' candidate for right lobe hepatectomy for living donor liver transplantation
Key inclusion criteria (1 listed)
- Sample of 40 healthy ASA I or II donors' candidate for right lobe hepatectomy for living donor liver transplantation
Key exclusion criteria (1 listed)
- Lack of consent
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 |
|---|---|---|
| Massimo for Pleth variability indexTo assess fluid response | Device | Responders |
Primary outcome
Correlation between PPV and PVI before and after fluid resuscitation.
Time frame: 6 hours
Assess accuracy of device in fluid response
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Individual participant dataSharing planned: Yes. Decided to share the IPD
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.
Amr Hilal abdou principal investigator
Ain shams University, Faculty of medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fluid Response, run by Ain Shams University at 2 sites 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 1 inclusion and 1 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 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amr M Hilal Abdou, MD (+201001479037, amr_hilal@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between PPV and PVI before and after fluid resuscitation. (time frame: 6 hours). 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 4 Jun 2019; AzTrials last refreshed its copy on 1 Nov 2026.