OIL: Organ Dysfunction Associated With Intra Abdominal Pressures in Liver Transplantation

Sponsor

Institute of Liver and Biliary Sciences, India (Other)

Overall Status

Recruiting

CT.gov ID

NCT04463745

Collaborator

(none)

Enrollment

Location

11.5

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Liver Diseases Intra-Abdominal Hypertension Cirrhosis, Liver Organ Dysfunction Syndrome

Study Design

Study Type:

Observational

Anticipated Enrollment :

25 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Organ Dysfunction Associated With Intraabdominal Pressures in Liver Transplantation

Actual Study Start Date :

Jul 15, 2020

Anticipated Primary Completion Date :

Jun 15, 2021

Anticipated Study Completion Date :

Jun 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Liver Transplant Recipients adult patients undergoing liver transplantation

Outcome Measures

Primary Outcome Measures

28 day mortality [28 days]
mortality of any cause in the fist 28 days after transplantation
duration of icu stay [28 days]
time period spent in the intensive care unit

Secondary Outcome Measures

Acute kidney injury in 1st week [7 days]
incidence of acute kidney injury in 1 week of transplantation
Respiratory complications [7 days]
includes duration of ventilation, incidence of vap
major neurological complications [7 days]
any major neurological event