Liver TransplantationNCT03396159
Validity of Mini Fluid Challenge Post Liver Transplantation
A study testing mini fluid challenge in people with Liver Transplantation, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
our study aim to assess the validity of using mini fluid challenge to assess the volaemic status of patients after liver transplantation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- mini fluid challenge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jan 2018to 20 May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients post liver transplantation.
- ASA III- IV
- Age > 18 years
Who cannot join
- Age less than 18 years.
- Patient with fulminant liver failure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validity of Mini Fluid Challenge to Assess Fluid Responsiveness Post Liver Transplantation
our study aim to assess the validity of using mini fluid challenge to assess the volaemic status of patients after liver transplantation
Read the detailed description
After approval of institutional ethical committee and after informed patient consent, patients fulfilling criteria will be involved. Upon ICU admission, patients will be connected to full monitoring and confirming patient hemodynamic stability and no active bleeding through drains. Patients will be in supine position and baseline readings will be recorded. Fluid responsiveness will be assessed with mini fluid challenge by 150 ml of albumin 5% given over 1 minute. After fluid administration stroke volume (SV) assessed by trans thoracic echo (TTE) and other hemodynamic parameters will be recorded. Remaining 350 ml of albumin 5% will be continued over 14 minute to have total volume given 500 ml. after fluid administration SV and other parameters will be recorded. The fluid challenge will be given intravenously via a specific wide pore venous line. Fluid responsiveness will be defined as an increase in the SV by 15% after the infusion of fluid.
TT 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 parasternal 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 apical view.
The sonographer manually will trace the velocity-time envelope (VTI). SV values will be calculated by multiplying VTI by cross sectional area.
- Conditions
- Liver Transplantation
- Being tested
- mini fluid challenge
- Keywords
- liver transplantation, mini fluid challenge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mini fluid challengeDiagnostic test
mini fluid challenge will be given to diagnose if patient is need fluid resuscitation or not
| Study group | Role | What they receive |
|---|---|---|
| mini fluid challenge | Experimental | mini fluid will be given and stroke volume will be assessed before and after Receives: Diagnostic Test: mini fluid challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
stroke volume
assessed by trans thoracic echo
Measured: 1 minute after mini fluid administration
Secondary outcomes (3)
heart rate
Measured: baseline 10 minutes after intensive care admission, 1 minute after mini fluid challenge and 1 minute after 500 ml of fluid administration
stroke volume
assessed by trans thoracic echo
Measured: baseline 10 minutes after intensive care admission and 1 minute after 500 ml of fluid administration
mean arterial blood pressure
Measured: baseline 10 minutes after intensive care admission and 1 minute after 500 ml of fluid administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start30 Jan 2018
- Primary completion20 May 2018
- Study completion20 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Diagnosis
- 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
- NCT03396159
- Sponsor's protocol ID
- N-6-2018
- Status last verified
- Jul 2018
- First submitted
- 25 Dec 2017
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 10840602Leavy JA, Weil MH, Rackow EC. 'Lactate washout' following circulatory arrest. JAMA. 1988 Aug 5;260(5):662-4.
PubMed 3392792Kiszka-Kanowitz M, Henriksen JH, Moller S, Bendtsen F. Blood volume distribution in patients with cirrhosis: aspects of the dual-head gamma-camera technique. J Hepatol. 2001 Nov;35(5):605-12. doi: 10.1016/s0168-8278(01)00175-1.
PubMed 11690706Henriksen JH. Volume adaptation in chronic liver disease: on the static and dynamic location of water, salt, protein and red cells in cirrhosis. Scand J Clin Lab Invest. 2004;64(6):523-33. doi: 10.1080/00365510410002788.
PubMed 15370457Mukhtar A, Awad M, Elayashy M, Hussein A, Obayah G, El Adawy A, Ahmed M, Dahab HA, Hasanin A, Elfouly A, Abdo M, Abdelaal A, Teboul JL. Validity of mini-fluid challenge for predicting fluid responsiveness following liver transplantation. BMC Anesthesiol. 2019 Apr 13;19(1):56. doi: 10.1186/s12871-019-0728-4.
PubMed 30987597
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of Mini Fluid Challenge to Assess Fluid Responsiveness Post Liver Transplantation
- ClinicalTrials.gov ID
- NCT03396159
- Acronym / sponsor ID
- N-6-2018
- Conditions
- Liver Transplantation
- Keywords
- liver transplantation, mini fluid challenge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 20 May 2018 (actual)
- Study completion
- 20 May 2018 (actual)
- First posted
- 10 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.
our study aim to assess the validity of using mini fluid challenge to assess the volaemic status of patients after liver transplantation
Detailed description
After approval of institutional ethical committee and after informed patient consent, patients fulfilling criteria will be involved. Upon ICU admission, patients will be connected to full monitoring and confirming patient hemodynamic stability and no active bleeding through drains. Patients will be in supine position and baseline readings will be recorded. Fluid responsiveness will be assessed with mini fluid challenge by 150 ml of albumin 5% given over 1 minute. After fluid administration stroke volume (SV) assessed by trans thoracic echo (TTE) and other hemodynamic parameters will be recorded. Remaining 350 ml of albumin 5% will be continued over 14 minute to have total volume given 500 ml. after fluid administration SV and other parameters will be recorded. The fluid challenge will be given intravenously via a specific wide pore venous line. Fluid responsiveness will be defined as an increase in the SV by 15% after the infusion of fluid.
TT 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 parasternal 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 apical view.
The sonographer manually will trace the velocity-time envelope (VTI). SV values will be calculated by multiplying VTI by cross sectional area.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mini fluid challenge | Experimental | Diagnostic Test: mini fluid challengemini fluid will be given and stroke volume will be assessed before and after |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients post liver transplantation.
- ASA III- IV
- Age > 18 years
Key exclusion criteria (2 listed)
- Age less than 18 years.
- Patient with fulminant liver failure.
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 |
|---|---|---|
| mini fluid challengemini fluid challenge will be given to diagnose if patient is need fluid resuscitation or not | Diagnostic test | mini fluid challenge |
Primary outcome
stroke volume
Time frame: 1 minute after mini fluid administration
assessed by trans thoracic echo
3 secondary outcomes
heart rate
Time frame: baseline 10 minutes after intensive care admission, 1 minute after mini fluid challenge and 1 minute after 500 ml of fluid administration
stroke volume
Time frame: baseline 10 minutes after intensive care admission and 1 minute after 500 ml of fluid administration
mean arterial blood pressure
Time frame: baseline 10 minutes after intensive care admission and 1 minute after 500 ml of fluid administration
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 23 Jul 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 3392792Leavy JA, Weil MH, Rackow EC. 'Lactate washout' following circulatory arrest. JAMA. 1988 Aug 5;260(5):662-4.
- Background: PubMed 11690706Kiszka-Kanowitz M, Henriksen JH, Moller S, Bendtsen F. Blood volume distribution in patients with cirrhosis: aspects of the dual-head gamma-camera technique. J Hepatol. 2001 Nov;35(5):605-12. doi: 10.1016/s0168-8278(01)00175-1.
- Background: PubMed 15370457Henriksen JH. Volume adaptation in chronic liver disease: on the static and dynamic location of water, salt, protein and red cells in cirrhosis. Scand J Clin Lab Invest. 2004;64(6):523-33. doi: 10.1080/00365510410002788.
- Derived from this study: PubMed 30987597Mukhtar A, Awad M, Elayashy M, Hussein A, Obayah G, El Adawy A, Ahmed M, Dahab HA, Hasanin A, Elfouly A, Abdo M, Abdelaal A, Teboul JL. Validity of mini-fluid challenge for predicting fluid responsiveness following liver transplantation. BMC Anesthesiol. 2019 Apr 13;19(1):56. doi: 10.1186/s12871-019-0728-4.
- Individual participant dataSharing planned: No
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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 mini fluid challenge 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 23 Jul 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: 1 minute after mini fluid administration). 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 NCT03396159, which also lists 5 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 23 Jul 2018.