Liver TransplantationNCT03228329
Validation of Cardiometry in Resuscitation of Patients Undergoing Liver Transplantation
A study testing fluid boluses in people with Liver Transplantation, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
aim of our study to validate electrical cardiometry readings against same readings by transoesophageal echo. we will validate stroke volume (SV) readings stroke volume variation(SVV), index of contractility. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- fluid boluses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2017to 20 Sep 2018
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA II to IV patients with end-stage liver disease
- patients undergoing orthotopic living donor liver transplantation
- age > 18 years
Who cannot join
- acute fulminant liver failure
- age < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Electrical Cardiometry in Resuscitation of Patients Undergoing Orthotopic Liver Transplantation
aim of our study to validate electrical cardiometry readings against same readings by transoesophageal echo. we will validate stroke volume (SV) readings stroke volume variation(SVV), index of contractility.
Read the detailed description
Induction of anaesthesia will be by using propofol (2mg.kg) IV, fentanyl (1-2μg. kg) IV and atracurium (0.5 mg.kg) IV. Anaesthesia will be maintained with Sevoflurane adjusted between 1-2% in an air ⁄ oxygen mix (FiO2 0.6), fentanyl infusion at 1-2 μg.kg/h and atracurium infusion at 0.5 mg.kg/ h. Mechanical ventilation will be provided by using a Dräger anaesthesia machine (Dräger Primus®, Germany) using a tidal volume of 6-8 ml.kg with the respiratory rate adjusted to maintain the PaCO2 between 4-4.6 kilopascal (kPa) and positive end expiratory pressure (PEEP) of 5 cmH2O. All patients will be monitored for five lead ECG, peripheral oxygen saturation, noninvasive and invasive arterial blood pressure, temperature, end-tidal carbon dioxide tension, hourly urinary output, and central venous pressure (CVP). A 7-Fr triple lumen CVP catheter (Arrow International Inc, Reading, PA, USA) will be inserted into the right internal jugular vein.
All patients will receive 6ml /kg/h Ringer acetate solution as a maintenance intraoperative fluid. If SVV is more than 15%, the patient will be considered as fluid responder and will receive a 250-ml bolus of albumin 5% to maintain SVV ≤15%. Blood transfusion will be given based on a hemoglobin level (< 7 g/dl). Norepinephrine will be administered if the mean arterial pressure was less than 70 mmHg. Epinephrine will be administered if mean arterial blood pressure was less than 70 mm Hg and the cardiac index was less than 2.5 L/min/m2 despite sufficient volume infusion, to maintain a target cardiac index of 2.5-3.0 L/min/m2
Electrical cardiometry (EC) Examination:
- ECG electrodes will be placed on the bare skin of patients in the following positions:
- On the left neck below the ear;
- Directly above the midpoint of the left clavicle;
- Along the left mid-axillary line at the level of the xiphoid process;
- Two inches caudal from the third electrode.
- Patient characteristics of sex, age, height and weight will be entered into the monitor.
- Clocks on the EC and trans esophageal echo (TEE) machine will be synchronized prior to data collection.
- The EC monitor will be programmed to capture moving averages of variables based on the previous 10 cardiac cycles and to record those averages every10 s.
- Only EC data with a signal quality index (SQI) of >70 will be included in the analysis.
Echo Examination:
- A single LVOT diameter will be measured for each patient as the distance between the inflection points at the base of the aortic valve cusps from the left ventricle long axis view during systole.
- Assuming a circular cross section, the LVOT area will be calculated from the LVOT diameter as: π X (LVOT diameter/ 2)2 = (LVOT diameter)2 X 0.785
- Pulse wave Doppler sampling cursor will be placed in the middle of the LVOT immediately proximal to the aortic valve in 5 chamber deep transgastric view.
- The sonographer manually will trace the velocity-time envelope.
- SV values will be identified for 10 cycles and averaged to obtain SV-Doppler max and SV-Doppler min. The mean SV (SV-Doppler mean) will be calculated as (SV-Doppler max - SV-Doppler min)/2.
- SVV-Doppler will be calculated as (SV-Doppler max - SV-Doppler min)/SV-Doppler mean.
- Peak aortic velocity, time to peak and mean acceleration will be calculated.
Mini Fluid challenge:
- Mini fluid challenge will be done by 150 cc crystalloid over 1 min
- 2 sets of measurement of SV and SVV will be obtained
- The first set of measurement will be obtained before fluid challenge.
- The second set will be obtained immediately after fluid challenge. Other data will be recorded as;heart rate (HR), systolic BP, Diastolic BP, mean BP, CVP and pulse pressure variation (PPV)
- Conditions
- Liver Transplantation
- Being tested
- fluid boluses
- Keywords
- cardiometry, stroke volume, liver transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluid bolusesOther
fluid boluses will be given when there will be hypovolemia assessed by presence of pulse pressure variations
| Study group | Role | What they receive |
|---|---|---|
| cardiometry | Other | fluid boluses will be given when there will be hypovolemia assessed by presence of pulse pressure variations Receives: Other: fluid boluses |
What is being measured
The primary outcome is the main question the study is designed to answer.
stroke volume
record stroke volume assessed by noninvasive cardiometry and TEE
Measured: 5 minutes after reperfusion.
stroke volume
record stroke volume assessed by noninvasive cardiometry and TEE
Measured: 15 minutes after dissection phase.
Secondary outcomes (2)
stroke volume variation
record stroke volume assessed by noninvasive cardiometry and TEE
Measured: 5 minutes after reperfusion.
stroke volume variation
record stroke volume variation assessed by noninvasive cardiometry and TEE
Measured: 15 minutes after dissection phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start10 Aug 2017
- Primary completion20 Sep 2018
- Study completion20 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Elayashy Mohamed Ahmed Hassan, Kasr El Aini Hospital
- Investigators
- ahmed mohamed mokhtar, M.D, Study director, kasralainy faculty of medicine, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03228329
- Sponsor's protocol ID
- N-43-2017
- Status last verified
- Dec 2018
- First submitted
- 13 Jul 2017
- Last updated
- 24 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bechstein WO, Neuhaus P. [Bleeding problems in liver surgery and liver transplantation]. Chirurg. 2000 Apr;71(4):363-8. doi: 10.1007/s001040051066. German.
PubMed 10840602Rossi G, Langer M, Maggi U, Reggiani P, Caccamo L, Gatti S, Paone G, Vannelli A, Prato P, Doglia M, Melada E, Latham L, Fassati LR. Veno-venous bypass versus no bypass in orthotopic liver transplantation: hemodynamic, metabolic, and renal data. Transplant Proc. 1998 Aug;30(5):1871-3. doi: 10.1016/s0041-1345(98)00465-5. No abstract available.
PubMed 9723316Bulkley GB. Reactive oxygen metabolites and reperfusion injury: aberrant triggering of reticuloendothelial function. Lancet. 1994 Oct 1;344(8927):934-6. doi: 10.1016/s0140-6736(94)92276-4. No abstract available.
PubMed 7848422Mukhtar AM, Elayashy M, Sayed AH, Obaya GM, Eladawy AA, Ali MA, Dahab HM, Khalaf DZ, Mohamed MA, Elfouly AH, Behairy GM, Abdelaal AA. Validation of electrical velocimetry in resuscitation of patients undergoing liver transplantation. Observational study. J Clin Monit Comput. 2020 Apr;34(2):271-276. doi: 10.1007/s10877-019-00313-z. Epub 2019 Apr 19.
PubMed 31004273
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Electrical Cardiometry in Resuscitation of Patients Undergoing Orthotopic Liver Transplantation
- ClinicalTrials.gov ID
- NCT03228329
- Acronym / sponsor ID
- N-43-2017
- Conditions
- Liver Transplantation
- Keywords
- cardiometry, stroke volume, liver transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 10 Aug 2017 (actual)
- Primary completion
- 20 Sep 2018 (actual)
- Study completion
- 20 Sep 2018 (actual)
- First posted
- 24 Jul 2017 (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.
aim of our study to validate electrical cardiometry readings against same readings by transoesophageal echo. we will validate stroke volume (SV) readings stroke volume variation(SVV), index of contractility.
Detailed description
Induction of anaesthesia will be by using propofol (2mg.kg) IV, fentanyl (1-2μg. kg) IV and atracurium (0.5 mg.kg) IV. Anaesthesia will be maintained with Sevoflurane adjusted between 1-2% in an air ⁄ oxygen mix (FiO2 0.6), fentanyl infusion at 1-2 μg.kg/h and atracurium infusion at 0.5 mg.kg/ h. Mechanical ventilation will be provided by using a Dräger anaesthesia machine (Dräger Primus®, Germany) using a tidal volume of 6-8 ml.kg with the respiratory rate adjusted to maintain the PaCO2 between 4-4.6 kilopascal (kPa) and positive end expiratory pressure (PEEP) of 5 cmH2O. All patients will be monitored for five lead ECG, peripheral oxygen saturation, noninvasive and invasive arterial blood pressure, temperature, end-tidal carbon dioxide tension, hourly urinary output, and central venous pressure (CVP). A 7-Fr triple lumen CVP catheter (Arrow International Inc, Reading, PA, USA) will be inserted into the right internal jugular vein.
All patients will receive 6ml /kg/h Ringer acetate solution as a maintenance intraoperative fluid. If SVV is more than 15%, the patient will be considered as fluid responder and will receive a 250-ml bolus of albumin 5% to maintain SVV ≤15%. Blood transfusion will be given based on a hemoglobin level (< 7 g/dl). Norepinephrine will be administered if the mean arterial pressure was less than 70 mmHg. Epinephrine will be administered if mean arterial blood pressure was less than 70 mm Hg and the cardiac index was less than 2.5 L/min/m2 despite sufficient volume infusion, to maintain a target cardiac index of 2.5-3.0 L/min/m2
Electrical cardiometry (EC) Examination:
- ECG electrodes will be placed on the bare skin of patients in the following positions:
- On the left neck below the ear;
- Directly above the midpoint of the left clavicle;
- Along the left mid-axillary line at the level of the xiphoid process;
- Two inches caudal from the third electrode.
- Patient characteristics of sex, age, height and weight will be entered into the monitor.
- Clocks on the EC and trans esophageal echo (TEE) machine will be synchronized prior to data collection.
- The EC monitor will be programmed to capture moving averages of variables based on the previous 10 cardiac cycles and to record those averages every10 s.
- Only EC data with a signal quality index (SQI) of >70 will be included in the analysis.
Echo Examination:
- A single LVOT diameter will be measured for each patient as the distance between the inflection points at the base of the aortic valve cusps from the left ventricle long axis view during systole.
- Assuming a circular cross section, the LVOT area will be calculated from the LVOT diameter as: π X (LVOT diameter/ 2)2 = (LVOT diameter)2 X 0.785
- Pulse wave Doppler sampling cursor will be placed in the middle of the LVOT immediately proximal to the aortic valve in 5 chamber deep transgastric view.
- The sonographer manually will trace the velocity-time envelope.
- SV values will be identified for 10 cycles and averaged to obtain SV-Doppler max and SV-Doppler min. The mean SV (SV-Doppler mean) will be calculated as (SV-Doppler max - SV-Doppler min)/2.
- SVV-Doppler will be calculated as (SV-Doppler max - SV-Doppler min)/SV-Doppler mean.
- Peak aortic velocity, time to peak and mean acceleration will be calculated.
Mini Fluid challenge:
- Mini fluid challenge will be done by 150 cc crystalloid over 1 min
- 2 sets of measurement of SV and SVV will be obtained
- The first set of measurement will be obtained before fluid challenge.
- The second set will be obtained immediately after fluid challenge. Other data will be recorded as;heart rate (HR), systolic BP, Diastolic BP, mean BP, CVP and pulse pressure variation (PPV)
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cardiometry | Other | Other: fluid bolusesfluid boluses will be given when there will be hypovolemia assessed by presence of pulse pressure variations |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA II to IV patients with end-stage liver disease
- patients undergoing orthotopic living donor liver transplantation
- age > 18 years
Key exclusion criteria (2 listed)
- acute fulminant liver failure
- age < 18 years
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 bolusesfluid boluses will be given when there will be hypovolemia assessed by presence of pulse pressure variations | Other | cardiometry |
Primary outcome
stroke volume
Time frame: 5 minutes after reperfusion.
record stroke volume assessed by noninvasive cardiometry and TEE
stroke volume
Time frame: 15 minutes after dissection phase.
record stroke volume assessed by noninvasive cardiometry and TEE
2 secondary outcomes
stroke volume variation
Time frame: 5 minutes after reperfusion.
stroke volume variation
Time frame: 15 minutes after dissection phase
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 24 Dec 2018.
- Background: PubMed 10840602Bechstein WO, Neuhaus P. [Bleeding problems in liver surgery and liver transplantation]. Chirurg. 2000 Apr;71(4):363-8. doi: 10.1007/s001040051066. German.
- Background: PubMed 9723316Rossi G, Langer M, Maggi U, Reggiani P, Caccamo L, Gatti S, Paone G, Vannelli A, Prato P, Doglia M, Melada E, Latham L, Fassati LR. Veno-venous bypass versus no bypass in orthotopic liver transplantation: hemodynamic, metabolic, and renal data. Transplant Proc. 1998 Aug;30(5):1871-3. doi: 10.1016/s0041-1345(98)00465-5. No abstract available.
- Background: PubMed 7848422Bulkley GB. Reactive oxygen metabolites and reperfusion injury: aberrant triggering of reticuloendothelial function. Lancet. 1994 Oct 1;344(8927):934-6. doi: 10.1016/s0140-6736(94)92276-4. No abstract available.
- Derived from this study: PubMed 31004273Mukhtar AM, Elayashy M, Sayed AH, Obaya GM, Eladawy AA, Ali MA, Dahab HM, Khalaf DZ, Mohamed MA, Elfouly AH, Behairy GM, Abdelaal AA. Validation of electrical velocimetry in resuscitation of patients undergoing liver transplantation. Observational study. J Clin Monit Comput. 2020 Apr;34(2):271-276. doi: 10.1007/s10877-019-00313-z. Epub 2019 Apr 19.
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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.
ahmed mohamed mokhtar, M.D study director
kasralainy faculty of medicine, Cairo university
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 boluses in people with Liver Transplantation, run by Kasr El Aini Hospital 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 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 24 Dec 2018. 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?
stroke volume (time frame: 5 minutes after reperfusion.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03228329, which also lists 4 linked publications.
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 24 Dec 2018.