Organ Dysfunction Associated With Intra Abdominal Pressures in Liver Transplantation

Liver Diseases Clinical Trial

— OIL  

Official title:

Organ Dysfunction Associated With Intraabdominal Pressures in Liver Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04463745
• Other study ID #: ILBS - Liver Transplant-3
• Status: Recruiting
• Start date: July 15, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: September 2020
• Source: Institute of Liver and Biliary Sciences, India
• Contact: Karthik Ponnappan
• Phone: +919840163951
• Email: kdtkp[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: June 30, 2021
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• patients undergoing liver transplantation
• 18 to 65 years

Exclusion Criteria:

• pregnant patients
• primary diagnosis of Acute liver failure and acute on chronic liver failure

Related Conditions & MeSH terms

• Cirrhosis, Liver
• Fibrosis
• Intra-Abdominal Hypertension
• Liver Cirrhosis
• Liver Diseases
• Organ Dysfunction Syndrome

Locations

Country	Name	City	State
India	Institute of Liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28 day mortality	mortality of any cause in the fist 28 days after transplantation	28 days
Primary	duration of icu stay	time period spent in the intensive care unit	28 days
Secondary	Acute kidney injury in 1st week	incidence of acute kidney injury in 1 week of transplantation	7 days
Secondary	Respiratory complications	includes duration of ventilation, incidence of vap	7 days
Secondary	major neurological complications	any major neurological event	7 days