Organ Dysfunction Associated With Intra Abdominal Pressures in Liver Transplantation

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

• Registration Number: NCT04463745
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-06
• Study First Submitted QC: 2020-07-06
• Study First Posted: 2020-07-09
• Study Start: 2020-07-15
• Status Verified: 2020-09
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-04
• Primary Completion: 2021-06-15
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Institute of Liver and Biliary Sciences; 🇮🇳 New Delhi, Delhi, India