Liver Transplant; ComplicationsNCT04413695
Lung Ultrasound as a Point of Care Test for Living Donor Liver Transplant Recipients.
An observational study of Liver Transplant; Complications, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Liver transplant is now a standard treatment for end-stage liver disease patients. Pulmonary complications are common in the perioperative period and are associated with adverse outcomes. This includes atelectasis, pneumothorax, pleural effusion, pulmonary edema, and collapse. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Transplant; Complications
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 11 Nov 2019to 25 Sep 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: End stage liver disease patients
Who may be able to join
- Age 18 to 65yrs All end stage liver disease patients undergoing live donor liver transplantation
Who cannot join
- Patients not giving consent for enrollment Any structural cardiac condition Dead donor liver transplant
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Gaurav Sindwani
New Delhi, National Capital Territory of Delhi, 110070
gaurav sindwani, md, 08728089898, drsindwani25@gmail.com
About this study
Official title: Lung Ultrasound as a Point of Care Test for Living Donor Liver Transplant Recipients: A Prospective Observational Study
Liver transplant is now a standard treatment for end-stage liver disease patients. Pulmonary complications are common in the perioperative period and are associated with adverse outcomes. This includes atelectasis, pneumothorax, pleural effusion, pulmonary edema, and collapse. Risk factors for the same are extensive surgery, transfusion of blood products, fluid overload, hemodynamic instability, coagulation abnormalities, renal dysfunction, and reperfusion syndrome. CXR with clinical judgment plays a key role in diagnosing pulmonary complications. However diagnostic ability of CXR is limited and moreover it is associated with unnecessary radiation exposure. Recently, lung USG has come up as an easily available tool to detect peri-op pulmonary complications. The technique is very easy to perform, less time-consuming, and totally cost-effective. Moreover, it can be easily learned by clinicians with a standard level of ability to handle an ultrasound probe for abdominal scans. In the setting of geriatric and ICU patients, fragility and immobility have a strong impact on the quality of a chest radiograph. So, the routine application of lung USG in this setting may significantly improve the outcome. Multiple studies have suggested that Lung USG is superior to CXR in diagnosing these lung conditions. Hence, this study aims to compare the lung ultrasound with CXR in detecting perioperative pulmonary complications in patients undergoing live donor liver transplantation.
Read the detailed description
This is a prospective observational study on liver transplant recipient patients, until postoperative day seven. After approval of the ethical committee and written informed consent, all liver transplant recipients meeting inclusion criteria are enrolled in the study. Patient characteristics like the cause of liver failure, CTP scoring, MELD Na scoring, graft vs recipient weight ratio, age, weight, height, BMI, pulmonary and other comorbidities are noted. Both lung ultrasound and CXR are done simultaneously in all patients on: one day prior to surgery and post-operatively from day 1 to day 7. Ultrasound is done by an experienced anesthesiologist with good experience in lung ultrasound, while the CXR was interpreted by the another physician. Based on the findings in the different regions of the thorax, a lung ultrasound score (LUS) is calculated as the following:- Each hemithorax is divided into anterior-lateral sectors (from parasternal to posterior axillary lines) and posterior sectors (from posterior axillary to paravertebral line). Each sector then divided into upper and lower halves taking the third intercostal space as reference, so that 4 areas could be finally identified for each hemithorax. The probe was set perpendicular, oblique, and parallel to the ribs to assess the degree of lung aeration with a total of 8 zones to be examined using a linear and convex probe. Image interpretation will be according to Lung Ultrasound Score. Lung ultrasound score varies from 0-3 [0 = normal aeration; 1 = moderate loss of aeration (interstitial syndrome, defined by multiple spaced B lines, or localized pulmonary edema, defined by coalescent B lines in less than 50% of the intercostal space examined in the transversal plane, or subpleural consolidations); 2 = severe loss of aeration (alveolar edema, defined by diffused coalescent B lines occupying the whole intercostal space); 3 = complete loss of lung aeration (lung consolidation defined as a tissue pattern with or without air bronchogram)]. The LUS is calculated as the sum of the 12 regional scores. Along with the LUS, other complications like atelectasis, pulmonary edema, consolidation, effusion and collapse are also noted. The LUS will be correlated with clinically relevant perioperative pulmonary complications (POPC) and the length of the ICU stay. The clinically relevant POPC are defined when any of the following present:
1.Increase in RR >25/min 2. The need of FIO2>10% 3. Increase Need of PS by 5cm of H2O and need of PEEP by 2cm of H20 4.The need of IMV, reinitiation of NIV, and insertion of ICD. Both CXR and lung ultrasound findings are compared with respect to the day of appearance of complications on CXR and ultrasound. In addition the data will be collected for the total duration of the complication, total length of icu and hospital stay.
.
- Conditions
- Liver Transplant; Complications
- Keywords
- liver transplant, lung ultrasound, chest x ray
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of day of appearance of pulmonary complications on ultrasound and chest Xray
Comparison of day of appearance of pulmonary complications on ultrasound and chest Xray
Measured: till post operative seventh day
Secondary outcomes (2)
Incidence and types of postoperative pulmonary complications after live donor related liver transplant (LDLT)
Incidence and types of postoperative pulmonary complications after live donor related liver transplant (LDLT)
Measured: First post-operative seven days
Correlation of lung ultrasound score with clinically relevant perioperative pulmonary complications and length of icu stay
Correlation of lung ultrasound score with clinically relevant perioperative pulmonary complications and length of icu stay
Measured: First post-operative seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start11 Nov 2019
- Primary completion25 Sep 2021 (estimated)
- Study completion25 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaurav Sindwani, Institute of Liver and Biliary Sciences, India
- Investigators
- gaurav sindwani, md, Study chair, ilbs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413695
- Sponsor's protocol ID
- ILBSIndia 2
- Status last verified
- Oct 2021
- First submitted
- 30 May 2020
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Feltracco P, Carollo C, Barbieri S, Pettenuzzo T, Ori C. Early respiratory complications after liver transplantation. World J Gastroenterol. 2013 Dec 28;19(48):9271-81. doi: 10.3748/wjg.v19.i48.9271.
PubMed 24409054Ruchonnet-Metrailler I, Blanchon S, Luthold S, Wildhaber BE, Rimensberger PC, Barazzone-Argiroffo C, Mc Lin VA. Pulmonary complications after liver transplantation in children: risk factors and impact on early post-operative morbidity. Pediatr Transplant. 2018 Jul 17:e13243. doi: 10.1111/petr.13243. Online ahead of print.
PubMed 30019517Tierney DM, Boland LL, Overgaard JD, Huelster JS, Jorgenson A, Normington JP, Melamed RR. Pulmonary ultrasound scoring system for intubated critically ill patients and its association with clinical metrics and mortality: A prospective cohort study. J Clin Ultrasound. 2018 Jan;46(1):14-22. doi: 10.1002/jcu.22526. Epub 2017 Oct 6.
PubMed 28984373Zhao Z, Jiang L, Xi X, Jiang Q, Zhu B, Wang M, Xing J, Zhang D. Prognostic value of extravascular lung water assessed with lung ultrasound score by chest sonography in patients with acute respiratory distress syndrome. BMC Pulm Med. 2015 Aug 23;15:98. doi: 10.1186/s12890-015-0091-2.
PubMed 26298866Yin W, Zou T, Qin Y, Yang J, Li Y, Zeng X, Kang Y; Chinese Critical Ultrasound Study Group (CCUSG). Poor lung ultrasound score in shock patients admitted to the ICU is associated with worse outcome. BMC Pulm Med. 2019 Jan 3;19(1):1. doi: 10.1186/s12890-018-0755-9.
PubMed 30606165Soummer A, Perbet S, Brisson H, Arbelot C, Constantin JM, Lu Q, Rouby JJ; Lung Ultrasound Study Group. Ultrasound assessment of lung aeration loss during a successful weaning trial predicts postextubation distress*. Crit Care Med. 2012 Jul;40(7):2064-72. doi: 10.1097/CCM.0b013e31824e68ae.
PubMed 22584759
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Ultrasound as a Point of Care Test for Living Donor Liver Transplant Recipients: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04413695
- Acronym / sponsor ID
- ILBSIndia 2
- Conditions
- Liver Transplant; Complications
- Keywords
- liver transplant, lung ultrasound, chest x ray
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 25 Sep 2021 (estimated)
- Study completion
- 25 Sep 2021 (estimated)
- First posted
- 4 Jun 2020 (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.
Liver transplant is now a standard treatment for end-stage liver disease patients. Pulmonary complications are common in the perioperative period and are associated with adverse outcomes. This includes atelectasis, pneumothorax, pleural effusion, pulmonary edema, and collapse. Risk factors for the same are extensive surgery, transfusion of blood products, fluid overload, hemodynamic instability, coagulation abnormalities, renal dysfunction, and reperfusion syndrome. CXR with clinical judgment plays a key role in diagnosing pulmonary complications. However diagnostic ability of CXR is limited and moreover it is associated with unnecessary radiation exposure. Recently, lung USG has come up as an easily available tool to detect peri-op pulmonary complications. The technique is very easy to perform, less time-consuming, and totally cost-effective. Moreover, it can be easily learned by clinicians with a standard level of ability to handle an ultrasound probe for abdominal scans. In the setting of geriatric and ICU patients, fragility and immobility have a strong impact on the quality of a chest radiograph. So, the routine application of lung USG in this setting may significantly improve the outcome. Multiple studies have suggested that Lung USG is superior to CXR in diagnosing these lung conditions. Hence, this study aims to compare the lung ultrasound with CXR in detecting perioperative pulmonary complications in patients undergoing live donor liver transplantation.
Detailed description
This is a prospective observational study on liver transplant recipient patients, until postoperative day seven. After approval of the ethical committee and written informed consent, all liver transplant recipients meeting inclusion criteria are enrolled in the study. Patient characteristics like the cause of liver failure, CTP scoring, MELD Na scoring, graft vs recipient weight ratio, age, weight, height, BMI, pulmonary and other comorbidities are noted. Both lung ultrasound and CXR are done simultaneously in all patients on: one day prior to surgery and post-operatively from day 1 to day 7. Ultrasound is done by an experienced anesthesiologist with good experience in lung ultrasound, while the CXR was interpreted by the another physician. Based on the findings in the different regions of the thorax, a lung ultrasound score (LUS) is calculated as the following:- Each hemithorax is divided into anterior-lateral sectors (from parasternal to posterior axillary lines) and posterior sectors (from posterior axillary to paravertebral line). Each sector then divided into upper and lower halves taking the third intercostal space as reference, so that 4 areas could be finally identified for each hemithorax. The probe was set perpendicular, oblique, and parallel to the ribs to assess the degree of lung aeration with a total of 8 zones to be examined using a linear and convex probe. Image interpretation will be according to Lung Ultrasound Score. Lung ultrasound score varies from 0-3 [0 = normal aeration; 1 = moderate loss of aeration (interstitial syndrome, defined by multiple spaced B lines, or localized pulmonary edema, defined by coalescent B lines in less than 50% of the intercostal space examined in the transversal plane, or subpleural consolidations); 2 = severe loss of aeration (alveolar edema, defined by diffused coalescent B lines occupying the whole intercostal space); 3 = complete loss of lung aeration (lung consolidation defined as a tissue pattern with or without air bronchogram)]. The LUS is calculated as the sum of the 12 regional scores. Along with the LUS, other complications like atelectasis, pulmonary edema, consolidation, effusion and collapse are also noted. The LUS will be correlated with clinically relevant perioperative pulmonary complications (POPC) and the length of the ICU stay. The clinically relevant POPC are defined when any of the following present:
1.Increase in RR >25/min 2. The need of FIO2>10% 3. Increase Need of PS by 5cm of H2O and need of PEEP by 2cm of H20 4.The need of IMV, reinitiation of NIV, and insertion of ICD. Both CXR and lung ultrasound findings are compared with respect to the day of appearance of complications on CXR and ultrasound. In addition the data will be collected for the total duration of the complication, total length of icu and hospital stay.
.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- End stage liver disease patients
Key inclusion criteria (1 listed)
- Age 18 to 65yrs All end stage liver disease patients undergoing live donor liver transplantation
Key exclusion criteria (1 listed)
- Patients not giving consent for enrollment Any structural cardiac condition Dead donor liver transplant
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
Comparison of day of appearance of pulmonary complications on ultrasound and chest Xray
Time frame: till post operative seventh day
Comparison of day of appearance of pulmonary complications on ultrasound and chest Xray
2 secondary outcomes
Incidence and types of postoperative pulmonary complications after live donor related liver transplant (LDLT)
Time frame: First post-operative seven days
Correlation of lung ultrasound score with clinically relevant perioperative pulmonary complications and length of icu stay
Time frame: First post-operative seven days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Background: PubMed 24409054Feltracco P, Carollo C, Barbieri S, Pettenuzzo T, Ori C. Early respiratory complications after liver transplantation. World J Gastroenterol. 2013 Dec 28;19(48):9271-81. doi: 10.3748/wjg.v19.i48.9271.
- Background: PubMed 30019517Ruchonnet-Metrailler I, Blanchon S, Luthold S, Wildhaber BE, Rimensberger PC, Barazzone-Argiroffo C, Mc Lin VA. Pulmonary complications after liver transplantation in children: risk factors and impact on early post-operative morbidity. Pediatr Transplant. 2018 Jul 17:e13243. doi: 10.1111/petr.13243. Online ahead of print.
- Background: PubMed 28984373Tierney DM, Boland LL, Overgaard JD, Huelster JS, Jorgenson A, Normington JP, Melamed RR. Pulmonary ultrasound scoring system for intubated critically ill patients and its association with clinical metrics and mortality: A prospective cohort study. J Clin Ultrasound. 2018 Jan;46(1):14-22. doi: 10.1002/jcu.22526. Epub 2017 Oct 6.
- Background: PubMed 26298866Zhao Z, Jiang L, Xi X, Jiang Q, Zhu B, Wang M, Xing J, Zhang D. Prognostic value of extravascular lung water assessed with lung ultrasound score by chest sonography in patients with acute respiratory distress syndrome. BMC Pulm Med. 2015 Aug 23;15:98. doi: 10.1186/s12890-015-0091-2.
- Results publication: PubMed 30606165Yin W, Zou T, Qin Y, Yang J, Li Y, Zeng X, Kang Y; Chinese Critical Ultrasound Study Group (CCUSG). Poor lung ultrasound score in shock patients admitted to the ICU is associated with worse outcome. BMC Pulm Med. 2019 Jan 3;19(1):1. doi: 10.1186/s12890-018-0755-9.
- Results publication: PubMed 22584759Soummer A, Perbet S, Brisson H, Arbelot C, Constantin JM, Lu Q, Rouby JJ; Lung Ultrasound Study Group. Ultrasound assessment of lung aeration loss during a successful weaning trial predicts postextubation distress*. Crit Care Med. 2012 Jul;40(7):2064-72. doi: 10.1097/CCM.0b013e31824e68ae.
- 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.
gaurav sindwani, md study chair
ilbs
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 Liver Transplant; Complications, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
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 5 Oct 2021. 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 India. 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 gaurav sindwani, md (08728089898, drsindwani25@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of day of appearance of pulmonary complications on ultrasound and chest Xray (time frame: till post operative seventh day). 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 NCT04413695, which also lists 6 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 5 Oct 2021.