End Stage Liver DiseaseNCT01794637
Study of Peripheral Tissue Oxygenation in End-stage Liver Disease Patients During Liver Transplantation
An observational study of End Stage Liver Disease, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
End - stage liver disease can cause many problems to the patients including fatigue, weakness,jaundice, confusion, abdominal pain and distension. Another important problem is the cardiovascular system (heart and blood vessels). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Liver Disease
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2013to Mar 2016
- How long will I take part?
- 1 Day
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients suffering from end-stage liver disease scheduled for liver transplantation
Who may be able to join
- Adult patients suffering from end-stage liver disease scheduled for liver transplantation.
Who cannot join
- Patients with known peripheral vascular disease
- Patients receiving Oxygen therapy
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Hospital, London Health Science Center
London, Ontario, N6A 5A5
About this study
Official title: Study of Peripheral Microcirculatory Dysfunction in End-stage Liver Disease Patients During Liver Transplantation Using Near Infrared Spectroscopy
End - stage liver disease can cause many problems to the patients including fatigue, weakness,jaundice, confusion, abdominal pain and distension. Another important problem is the cardiovascular system (heart and blood vessels). There will be the impairment of heart function to pump blood to the distal part of the body. Blood vessels are also affected by the imbalance of chemical agents which are not detoxified by diseased liver, resulting in impairment of oxygen carrying capacity and tissue oxygen exchange. Mechanism of this process is still poorly understood.
This is a study about the peripheral vascular dysfunction by means of vascular occlusion test (VOT). Blood pressure cuff is inflated (to occlude the proximal vessels and induce distal part ischemia), then deflated and observing the distal tissue oxygenation (StO2)change by the probe (Near-infrared spectroscopy : NIRS) at the hand. From our knowledge, there is no study in patients undergoing liver transplantation.
The study investigator would like to observe the change in peripheral tissue oxygenation in different time points during the liver transplantation. We hypothesize that there is a change in microcirculatory function and StO2 in end-stage liver disease patients detected by VOT and NIRS.
Read the detailed description
End - stage liver disease patients scheduled for liver transplantation will be enrolled. They will receive normal standard of care. The VOT assessment using a non-invasive, integrated research device (InspectraTM StO2 Vascular Occlusion test (VOT) Research Device Hutchinson Corp Minn, MN, USA) and 15 mm Inspectra thenar sensor probe. An integrated blood pressure cuff is placed on the right arm and inflated to a pressure sufficient to produce arterial inflow occlusion (50mmHg above systolic pressure). The cuff remains inflated until a StO2 value of 40% is achieved. During the inflation and deflation, various StO2 parameters are measured and recorded at designed time point.
Specific VOT parameters of interest:
- Baseline StO2 (reflective of perfusion/metabolism ratio)
- Ischemia slope (partly reflective of basal O2 consumption)
- Ischemia area (partly reflective of basal O2 consumption)
- Time till 40% ischemic threshold (partly reflective of basal O2 consumption)
- Recovery slope (biphasic and reflective of shear stress and endothelial vasoreactivity)
- Recovery area (reflective of endothelial vasoreactivity)
- Hyperemia area (reflective of endothelial vasoreactivity and tissue metabolic rate) To determine effect of core versus peripheral temperatures, a conventional skin thermocouple will be placed under adhesive patch used to secure NIRS optodes in position on thenar eminence
Data collection
- Demographic data: a)age, b)sex, c)diagnosis, d)Model of End-stage Liver Disease (MELD) score, Body Mass Index (BMI)
- Clinical parameter : the investigator will collect clinical data including VOT parameters (from above), hemodynamics parameter, chemical parameters and medications used in specific time frame :
- time frame
- pre-operative (for base line data)
- pre-anhepatic phase (15 min. before the inferior vena cava (IVC) clamps)
- anhepatic phase (30 min. after the IVC clamps),
- reperfusion phase (30 min. after the release the IVC clamps),
- immediately post operation (at the skin closure)
- hemodynamics : SpO2 (Pulse oxygen saturation), MAP (mean arterial pressure), HR (heart rate), CVP (Central venous pressure), PAP (Pulmonary artery pressure), CI (Cardiac output index), PCWP (Pulmonary artery wedge pressure), SVRI (Systemic vascular resistance index), PVRI (Pulmonary vascular resistance index), temperature
- chemical : Hb, Platelets, INR (international normalized ratio) (PT : Prothrombin time), PTT (partial thromboplastin time), Lactate, base excess
- Medications : Volatile agents, Vasopressors (Concentration at recorded time points)
Then we will compare the dynamic changes of StO2 parameters in different time points (as mentioned) and compare to the hemodynamics and chemical parameters.
- Conditions
- End Stage Liver Disease
- Keywords
- End stage liver disease, Peripheral microcirculatory dysfunction, Liver transplantation, Near infrared spectroscopy
- Medical subject headings
- End Stage Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| the end-stage liver disease patients | the end-stage liver disease scheduled for liver transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the significant changes in StO2 between anhepatic and reperfusion phase of the end-stage liver disease patient undergoing liver transplantation
Our data measured will be included only during the operation and at skin closure can reflect early postoperative period.
Measured: compare the change of StO2 during different phase of the liver transplantation (base line, pre-anhepatic phase, anhepatic phase, re-perfusion phase and at skin closure)
Secondary outcomes (1)
dynamic changes in StO2 during liver transplantation with possible correlation with hemodynamic or chemical parameters in different time points
from previous study indicates that new liver start its metabolic function well right after the vascular connection complete. So, the investigator want to analyze the correlation between the dynamic StO2 changes during operative period
Measured: preoperative for baseline data, intraoperative (during different phase of liver transplantation) and finish data record at skin closure time)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: Disposables required for the measurements in short supply and not provided by the company / supplier
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for End Stage Liver DiseaseStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- 0 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Achal Dhir, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Achal Dhir, MD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01794637
- Sponsor's protocol ID
- 103363
- Status last verified
- Oct 2016
- First submitted
- 17 Jan 2013
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Groszmann RJ. Hyperdynamic circulation of liver disease 40 years later: pathophysiology and clinical consequences. Hepatology. 1994 Nov;20(5):1359-63. No abstract available.
PubMed 7927273Helmy A, Newby DE, Jalan R, Johnston NR, Hayes PC, Webb DJ. Nitric oxide mediates the reduced vasoconstrictor response to angiotensin II in patients with preascitic cirrhosis. J Hepatol. 2003 Jan;38(1):44-50. doi: 10.1016/s0168-8278(02)00319-7.
PubMed 12480559Okumura H, Aramaki T, Katsuta Y, Terada H, Satomura K, Akaike M, Sekiyama T. Regional differences in peripheral circulation between upper and lower extremity in patients with cirrhosis. Scand J Gastroenterol. 1990 Sep;25(9):883-9. doi: 10.3109/00365529008997608.
PubMed 2218394Caraceni P, Dazzani F, Salizzoni E, Domenicali M, Zambruni A, Trevisani F, Bernardi M. Muscle circulation contributes to hyperdynamic circulatory syndrome in advanced cirrhosis. J Hepatol. 2008 Apr;48(4):559-66. doi: 10.1016/j.jhep.2007.12.016. Epub 2008 Jan 31.
PubMed 18276031Seino Y, Ohki K, Nakamura T, Tsukamoto H, Takano T, Aramaki T, Okumura H, Hayakawa H. Pathophysiological characteristics of cutaneous microcirculation in patients with liver cirrhosis: relationships to cardiovascular hemodynamics and plasma neurohormonal factors. Microvasc Res. 1993 Sep;46(2):206-15. doi: 10.1006/mvre.1993.1047.
PubMed 8246819Poeze M. Tissue-oxygenation assessment using near-infrared spectroscopy during severe sepsis: confounding effects of tissue edema on StO2 values. Intensive Care Med. 2006 May;32(5):788-9. doi: 10.1007/s00134-006-0121-x. Epub 2006 Mar 17. No abstract available.
PubMed 16544119Harel F, Denault A, Ngo Q, Dupuis J, Khairy P. Near-infrared spectroscopy to monitor peripheral blood flow perfusion. J Clin Monit Comput. 2008 Feb;22(1):37-43. doi: 10.1007/s10877-007-9105-9. Epub 2007 Nov 27.
PubMed 18040873Thomson SJ, Cowan ML, Forton DM, Clark SJ, Musa S, Grounds M, Rahman TM. A study of muscle tissue oxygenation and peripheral microcirculatory dysfunction in cirrhosis using near infrared spectroscopy. Liver Int. 2010 Mar;30(3):463-71. doi: 10.1111/j.1478-3231.2009.02157.x. Epub 2009 Nov 16.
PubMed 19912533Steib A, Freys G, Gohard R, Curzola U, Ravanello J, Lutun P, Boudjema K, Otteni JC. Tissue oxygenation during liver transplantation. Crit Care Med. 1992 Jul;20(7):977-83. doi: 10.1097/00003246-199207000-00013.
PubMed 1617992Al-Hamoudi WK, Alqahtani S, Tandon P, Ma M, Lee SS. Hemodynamics in the immediate post-transplantation period in alcoholic and viral cirrhosis. World J Gastroenterol. 2010 Feb 7;16(5):608-12. doi: 10.3748/wjg.v16.i5.608.
PubMed 20128030Shelly MP, Dixon JS, Park GR. The pharmacokinetics of midazolam following orthotopic liver transplantation. Br J Clin Pharmacol. 1989 May;27(5):629-33. doi: 10.1111/j.1365-2125.1989.tb03428.x.
PubMed 2667599Hickman PE, Potter JM, Pesce AJ. Clinical chemistry and post-liver-transplant monitoring. Clin Chem. 1997 Aug;43(8 Pt 2):1546-54.
PubMed 9265907
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Peripheral Microcirculatory Dysfunction in End-stage Liver Disease Patients During Liver Transplantation Using Near Infrared Spectroscopy
- ClinicalTrials.gov ID
- NCT01794637
- Acronym / sponsor ID
- 103363
- Conditions
- End Stage Liver Disease
- Keywords
- End stage liver disease, Peripheral microcirculatory dysfunction, Liver transplantation, Near infrared spectroscopy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Disposables required for the measurements in short supply and not provided by the company / supplier
- Enrolment
- 0 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 20 Feb 2013 (estimated)
- 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.
End - stage liver disease can cause many problems to the patients including fatigue, weakness,jaundice, confusion, abdominal pain and distension. Another important problem is the cardiovascular system (heart and blood vessels). There will be the impairment of heart function to pump blood to the distal part of the body. Blood vessels are also affected by the imbalance of chemical agents which are not detoxified by diseased liver, resulting in impairment of oxygen carrying capacity and tissue oxygen exchange. Mechanism of this process is still poorly understood.
This is a study about the peripheral vascular dysfunction by means of vascular occlusion test (VOT). Blood pressure cuff is inflated (to occlude the proximal vessels and induce distal part ischemia), then deflated and observing the distal tissue oxygenation (StO2)change by the probe (Near-infrared spectroscopy : NIRS) at the hand. From our knowledge, there is no study in patients undergoing liver transplantation.
The study investigator would like to observe the change in peripheral tissue oxygenation in different time points during the liver transplantation. We hypothesize that there is a change in microcirculatory function and StO2 in end-stage liver disease patients detected by VOT and NIRS.
Detailed description
End - stage liver disease patients scheduled for liver transplantation will be enrolled. They will receive normal standard of care. The VOT assessment using a non-invasive, integrated research device (InspectraTM StO2 Vascular Occlusion test (VOT) Research Device Hutchinson Corp Minn, MN, USA) and 15 mm Inspectra thenar sensor probe. An integrated blood pressure cuff is placed on the right arm and inflated to a pressure sufficient to produce arterial inflow occlusion (50mmHg above systolic pressure). The cuff remains inflated until a StO2 value of 40% is achieved. During the inflation and deflation, various StO2 parameters are measured and recorded at designed time point.
Specific VOT parameters of interest:
- Baseline StO2 (reflective of perfusion/metabolism ratio)
- Ischemia slope (partly reflective of basal O2 consumption)
- Ischemia area (partly reflective of basal O2 consumption)
- Time till 40% ischemic threshold (partly reflective of basal O2 consumption)
- Recovery slope (biphasic and reflective of shear stress and endothelial vasoreactivity)
- Recovery area (reflective of endothelial vasoreactivity)
- Hyperemia area (reflective of endothelial vasoreactivity and tissue metabolic rate) To determine effect of core versus peripheral temperatures, a conventional skin thermocouple will be placed under adhesive patch used to secure NIRS optodes in position on thenar eminence
Data collection
- Demographic data: a)age, b)sex, c)diagnosis, d)Model of End-stage Liver Disease (MELD) score, Body Mass Index (BMI)
- Clinical parameter : the investigator will collect clinical data including VOT parameters (from above), hemodynamics parameter, chemical parameters and medications used in specific time frame :
- time frame
- pre-operative (for base line data)
- pre-anhepatic phase (15 min. before the inferior vena cava (IVC) clamps)
- anhepatic phase (30 min. after the IVC clamps),
- reperfusion phase (30 min. after the release the IVC clamps),
- immediately post operation (at the skin closure)
- hemodynamics : SpO2 (Pulse oxygen saturation), MAP (mean arterial pressure), HR (heart rate), CVP (Central venous pressure), PAP (Pulmonary artery pressure), CI (Cardiac output index), PCWP (Pulmonary artery wedge pressure), SVRI (Systemic vascular resistance index), PVRI (Pulmonary vascular resistance index), temperature
- chemical : Hb, Platelets, INR (international normalized ratio) (PT : Prothrombin time), PTT (partial thromboplastin time), Lactate, base excess
- Medications : Volatile agents, Vasopressors (Concentration at recorded time points)
Then we will compare the dynamic changes of StO2 parameters in different time points (as mentioned) and compare to the hemodynamics and chemical parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| the end-stage liver disease patients | – | –the end-stage liver disease scheduled for liver transplantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients suffering from end-stage liver disease scheduled for liver transplantation
Key inclusion criteria (1 listed)
- Adult patients suffering from end-stage liver disease scheduled for liver transplantation.
Key exclusion criteria (2 listed)
- Patients with known peripheral vascular disease
- Patients receiving Oxygen therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the significant changes in StO2 between anhepatic and reperfusion phase of the end-stage liver disease patient undergoing liver transplantation
Time frame: compare the change of StO2 during different phase of the liver transplantation (base line, pre-anhepatic phase, anhepatic phase, re-perfusion phase and at skin closure)
Our data measured will be included only during the operation and at skin closure can reflect early postoperative period.
1 secondary outcome
dynamic changes in StO2 during liver transplantation with possible correlation with hemodynamic or chemical parameters in different time points
Time frame: preoperative for baseline data, intraoperative (during different phase of liver transplantation) and finish data record at skin closure time)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2016.
- Background: PubMed 7927273Groszmann RJ. Hyperdynamic circulation of liver disease 40 years later: pathophysiology and clinical consequences. Hepatology. 1994 Nov;20(5):1359-63. No abstract available.
- Background: PubMed 12480559Helmy A, Newby DE, Jalan R, Johnston NR, Hayes PC, Webb DJ. Nitric oxide mediates the reduced vasoconstrictor response to angiotensin II in patients with preascitic cirrhosis. J Hepatol. 2003 Jan;38(1):44-50. doi: 10.1016/s0168-8278(02)00319-7.
- Background: PubMed 2218394Okumura H, Aramaki T, Katsuta Y, Terada H, Satomura K, Akaike M, Sekiyama T. Regional differences in peripheral circulation between upper and lower extremity in patients with cirrhosis. Scand J Gastroenterol. 1990 Sep;25(9):883-9. doi: 10.3109/00365529008997608.
- Background: PubMed 18276031Caraceni P, Dazzani F, Salizzoni E, Domenicali M, Zambruni A, Trevisani F, Bernardi M. Muscle circulation contributes to hyperdynamic circulatory syndrome in advanced cirrhosis. J Hepatol. 2008 Apr;48(4):559-66. doi: 10.1016/j.jhep.2007.12.016. Epub 2008 Jan 31.
- Background: PubMed 8246819Seino Y, Ohki K, Nakamura T, Tsukamoto H, Takano T, Aramaki T, Okumura H, Hayakawa H. Pathophysiological characteristics of cutaneous microcirculation in patients with liver cirrhosis: relationships to cardiovascular hemodynamics and plasma neurohormonal factors. Microvasc Res. 1993 Sep;46(2):206-15. doi: 10.1006/mvre.1993.1047.
- Background: PubMed 16544119Poeze M. Tissue-oxygenation assessment using near-infrared spectroscopy during severe sepsis: confounding effects of tissue edema on StO2 values. Intensive Care Med. 2006 May;32(5):788-9. doi: 10.1007/s00134-006-0121-x. Epub 2006 Mar 17. No abstract available.
- Background: PubMed 18040873Harel F, Denault A, Ngo Q, Dupuis J, Khairy P. Near-infrared spectroscopy to monitor peripheral blood flow perfusion. J Clin Monit Comput. 2008 Feb;22(1):37-43. doi: 10.1007/s10877-007-9105-9. Epub 2007 Nov 27.
- Background: PubMed 19912533Thomson SJ, Cowan ML, Forton DM, Clark SJ, Musa S, Grounds M, Rahman TM. A study of muscle tissue oxygenation and peripheral microcirculatory dysfunction in cirrhosis using near infrared spectroscopy. Liver Int. 2010 Mar;30(3):463-71. doi: 10.1111/j.1478-3231.2009.02157.x. Epub 2009 Nov 16.
- Background: PubMed 1617992Steib A, Freys G, Gohard R, Curzola U, Ravanello J, Lutun P, Boudjema K, Otteni JC. Tissue oxygenation during liver transplantation. Crit Care Med. 1992 Jul;20(7):977-83. doi: 10.1097/00003246-199207000-00013.
- Background: PubMed 20128030Al-Hamoudi WK, Alqahtani S, Tandon P, Ma M, Lee SS. Hemodynamics in the immediate post-transplantation period in alcoholic and viral cirrhosis. World J Gastroenterol. 2010 Feb 7;16(5):608-12. doi: 10.3748/wjg.v16.i5.608.
- Background: PubMed 2667599Shelly MP, Dixon JS, Park GR. The pharmacokinetics of midazolam following orthotopic liver transplantation. Br J Clin Pharmacol. 1989 May;27(5):629-33. doi: 10.1111/j.1365-2125.1989.tb03428.x.
- Background: PubMed 9265907Hickman PE, Potter JM, Pesce AJ. Clinical chemistry and post-liver-transplant monitoring. Clin Chem. 1997 Aug;43(8 Pt 2):1546-54.
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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.
Achal Dhir, MD principal investigator
Western University
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 End Stage Liver Disease, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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: withdrawn, as of the sponsor's last update on 4 Oct 2016. 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 Canada. 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 was withdrawn before enrolling participants, so there are no results.
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?
the significant changes in StO2 between anhepatic and reperfusion phase of the end-stage liver disease patient undergoing liver transplantation (time frame: compare the change of StO2 during different phase of the liver transplantation (base line, pre-anhepatic phase, anhepatic phase, re-perfusion phase and at skin closure)). 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 NCT01794637, which also lists 12 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 4 Oct 2016.