Organ Dysfunction Associated With Intra Abdominal Pressures in Liver Transplantation (OIL)

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.

Study Overview

• Status: Unknown
• Conditions: Liver Diseases; Intra-Abdominal Hypertension; Cirrhosis, Liver; Organ Dysfunction Syndrome

• Study Type: Observational
• Enrollment (Anticipated): 25

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Recruiting
      • Institute of liver and Biliary Sciences
      • Contact: Karthik Ponnappan T, DM; Phone Number: 9840163951; Email: karthik.kaper@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients undergoing liver transplantation for various indications , including chronic liver disease due to alcohol, NASH , viral hepatitis among others.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Liver Transplant Recipients; adult patients undergoing liver transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28 day mortality	mortality of any cause in the fist 28 days after transplantation	28 days
duration of icu stay	time period spent in the intensive care unit	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute kidney injury in 1st week	incidence of acute kidney injury in 1 week of transplantation	7 days
Respiratory complications	includes duration of ventilation, incidence of vap	7 days
major neurological complications	any major neurological event	7 days

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India
• Investigators: Principal Investigator: Karthik Ponnappan, Institute of liver and Biliary Sciences

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2020
• Primary Completion (Anticipated): June 15, 2021
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: July 6, 2020
• First Submitted That Met QC Criteria: July 6, 2020
• First Posted (Actual): July 9, 2020

Study Record Updates

• Last Update Posted (Actual): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: liver transplantation; intra-abdominal pressure; organ dysfunction; liver cirrhosis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Musculoskeletal Diseases; Muscular Diseases; Compartment Syndromes; Liver Diseases; Fibrosis; Liver Cirrhosis; Intra-Abdominal Hypertension
• Other Study ID Numbers: ILBS - Liver Transplant-3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No