Liver DiseasesOILNCT04463745
Organ Dysfunction Associated With Intra Abdominal Pressures in Liver Transplantation
An observational study of Liver Diseases and Intra-Abdominal Hypertension, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Patients with end stage liver disease have varying degrees of intra-abdominal hypertension (IAH) due to the presence of ascites. The perioperative events may either relieve or aggravate the intra-abdominal pressures. Intra-abdominal hypertension has damaging effect on various organ systems. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Diseases, Intra-Abdominal Hypertension, Cirrhosis, Liver
- How many people
- 25 participants
- Where
- 1 siteIndia
- Study dates
- 15 Jul 2020to 30 Jun 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: patients undergoing liver transplantation for various indications , including chronic liver disease due to alcohol, NASH , viral hepatitis among others.
Who may be able to join
- patients undergoing liver transplantation
- 18 to 65 years
Who cannot join
- pregnant patients
- primary diagnosis of Acute liver failure and acute on chronic liver failure
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
Karthik Ponnappan T, DM, 9840163951, karthik.kaper@gmail.com
About this study
Official title: Organ Dysfunction Associated With Intraabdominal Pressures in Liver Transplantation
Patients with end stage liver disease have varying degrees of intra-abdominal hypertension (IAH) due to the presence of ascites. The perioperative events may either relieve or aggravate the intra-abdominal pressures. Intra-abdominal hypertension has damaging effect on various organ systems. There is an increase in intracranial pressures and a decrease in cerebral perfusion pressures associated with IAH . In the heart, there is an increase of right atrial pressures, increase in systemic vascular resistance and decrease in cardiac output . Pulmonary complications include increase in the peak, mean and plateau airway pressures, with decreased compliance . Renal dysfunction is an early effect of raised intra-abdominal pressure, resulting from decreased renal blood flow, shunting of blood to the medulla, mechanical compression of the kidneys and increased pressures in the renal veins . We would study the intra-abdominal pressures in liver transplant recipients and record hemodynamic, respiratory, cardiac and renal function prospectively. Follow up data for 6 days for neurological, respiratory, cardiac and renal complications will be collected, along with hospital stay, ICU stay and mortality. The association between intra-abdominal pressures and these outcomes will be analysed.
- Conditions
- Liver Diseases, Intra-Abdominal Hypertension, Cirrhosis, Liver, Organ Dysfunction Syndrome
- Keywords
- organ dysfunction, intra-abdominal pressure, liver transplantation, liver cirrhosis
- Medical subject headings
- Liver Diseases, Intra-Abdominal Hypertension, Liver Cirrhosis
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 |
|---|---|---|
| Liver Transplant Recipients | adult patients undergoing liver transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
28 day mortality
mortality of any cause in the fist 28 days after transplantation
Measured: 28 days
duration of icu stay
time period spent in the intensive care unit
Measured: 28 days
Secondary outcomes (3)
Acute kidney injury in 1st week
incidence of acute kidney injury in 1 week of transplantation
Measured: 7 days
Respiratory complications
includes duration of ventilation, incidence of vap
Measured: 7 days
major neurological complications
any major neurological event
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start15 Jul 2020
- Primary completion15 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karthik Ponnappan, Principal investigator, Institute of Liver and Biliary Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04463745
- Sponsor's protocol ID
- ILBS - Liver Transplant-3
- Acronym
- OIL
- Status last verified
- Sep 2020
- First submitted
- 6 Jul 2020
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Organ Dysfunction Associated With Intraabdominal Pressures in Liver Transplantation
- ClinicalTrials.gov ID
- NCT04463745
- Acronym / sponsor ID
- OIL / ILBS - Liver Transplant-3
- Conditions
- Liver Diseases, Intra-Abdominal Hypertension, Cirrhosis, Liver, Organ Dysfunction Syndrome
- Keywords
- organ dysfunction, intra-abdominal pressure, liver transplantation, liver cirrhosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 15 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 9 Jul 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.
Patients with end stage liver disease have varying degrees of intra-abdominal hypertension (IAH) due to the presence of ascites. The perioperative events may either relieve or aggravate the intra-abdominal pressures. Intra-abdominal hypertension has damaging effect on various organ systems. There is an increase in intracranial pressures and a decrease in cerebral perfusion pressures associated with IAH . In the heart, there is an increase of right atrial pressures, increase in systemic vascular resistance and decrease in cardiac output . Pulmonary complications include increase in the peak, mean and plateau airway pressures, with decreased compliance . Renal dysfunction is an early effect of raised intra-abdominal pressure, resulting from decreased renal blood flow, shunting of blood to the medulla, mechanical compression of the kidneys and increased pressures in the renal veins . We would study the intra-abdominal pressures in liver transplant recipients and record hemodynamic, respiratory, cardiac and renal function prospectively. Follow up data for 6 days for neurological, respiratory, cardiac and renal complications will be collected, along with hospital stay, ICU stay and mortality. The association between intra-abdominal pressures and these outcomes will be analysed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver Transplant Recipients | – | –adult patients undergoing liver transplantation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing liver transplantation for various indications , including chronic liver disease due to alcohol, NASH , viral hepatitis among others.
Key inclusion criteria (2 listed)
- patients undergoing liver transplantation
- 18 to 65 years
Key exclusion criteria (2 listed)
- pregnant patients
- primary diagnosis of Acute liver failure and acute on chronic 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.
Primary outcome
28 day mortality
Time frame: 28 days
mortality of any cause in the fist 28 days after transplantation
duration of icu stay
Time frame: 28 days
time period spent in the intensive care unit
3 secondary outcomes
Acute kidney injury in 1st week
Time frame: 7 days
Respiratory complications
Time frame: 7 days
major neurological complications
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
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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.
Karthik Ponnappan principal investigator
Institute of Liver and Biliary Sciences, India
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 Diseases and Intra-Abdominal Hypertension, 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 2 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: status not confirmed, as of the sponsor's last update on 4 Feb 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 Karthik Ponnappan (+919840163951, kdtkp@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28 day mortality (time frame: 28 days). 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?
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 Feb 2021.