ICU Readmission in Adult Egyptian Patients Undergoing Living Donor Liver Transplant

ICU Readmission in Adult Egyptian Patients Undergoing Living Donor Liver Transplant: Incidence, Causes and Outcomes: A Single Centre Retrospective Observational Study

Liver transplantation is the only definitive treatment for end stage liver disease. Being a major abdominal surgery, may have postoperative complications that require readmission, which may be serious and life threatening. In general, patients who required ICU readmission showed higher morbidity, mortality and prolonged hospital stay compared to those who did not require readmission. We will conduct this retrospective observational study to identify incidence, causes and outcomes of ICU readmission after LDLT

Study Overview

• Status: Completed
• Conditions: ICU Readmission
• Intervention / Treatment: Other: non interventional study

Detailed Description

• This retrospective observational study will be conducted in Ain Shams University Specialized Hospital on 335 adult (age ≥18 years) Egyptian patients undergoing living donor liver transplant (LDLT) between 2008 to 2018. Patients' demographic data, preoperative variables, intraoperative variables, postoperative stay and complications, causes for ICU readmission, and outcomes after ICU readmission will be studied. Intraoperatively, Both standard anesthetic and piggyback LT for hepatic transplantation were performed by the same anesthesia and surgical team . Intraoperative patients were monitored with ECG, invasive arterial blood pressure (left radial artery), noninvasive blood pressure, continuous central venous pressure (CVP), body temperature, oxygen saturation (SaO2), capnometry (EtCO2) and urine output (mL). Intraoperative hemodynamics (MAP and HR), graft weight to recipient weight ratio (GWRWR), blood products transfused and intraoperative adverse events were recorded. At the end of surgery patients were transferred to the ICU where they were monitored and received the standard protocol for postoperative management after liver transplantation.
• The postoperative immunosuppressive protocols includes calcinurine inhibitors( FK or cyclosporine), and steroids with or without mycophynolate. Piperacillin/ tazobactam was used as early prophylaxis for bacterial infections and metronidazole as prophylaxis for anaerobic infection. Patients with an uncomplicated postoperative course and good liver function will be transferred from the ICU within 3 - 5 days to a designated transplantation inpatient unit where they will be closely followed up by surgical and medical team, as well as by pharmacists, nutritionists, and physical therapists.

• Study Type: Observational
• Enrollment (Actual): 299

Contacts and Locations

Study Locations

• Egypt
  • Ain Shams University Specialized Hospital
    • Cairo, Ain Shams University Specialized Hospital, Egypt
      • Hanaa El Gendy

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

Patients' demographic data, preoperative variables, intraoperative variables, postoperative stay and complications, causes for ICU readmission, and outcomes after ICU readmission will be studied.Intraoperatively patients were monitored. Intraoperative adverse events were recorded. At the end of surgery patients were transferred to the ICU.

- The postoperative immunosuppressive protocols includes calcinurine inhibitors( FK or cyclosporine), and steroids with or without mycophynolate. Piperacillin/ tazobactam was used as early prophylaxis for bacterial infections and metronidazole as prophylaxis for anaerobic infection. Patients with an uncomplicated postoperative course and good liver function will be transferred from the ICU within 3 - 5 days to a designated transplantation inpatient unit.

Description

Inclusion Criteria:

• Adult Egyptian Patients >18 years

Exclusion Criteria:

• Patient refusal.
• Patients who were not discharged after LDLT due to death.
• Patients who underwent re-transplantation before discharge from the ICU after the first liver transplant.
• Pregnancy.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Readmission group; Readmission is defined as ICU readmission within ≤ 3 months of initial ICU discharge	Other: non interventional study; non interventional study
Non readmitted group; Non readmission is defined as no need for ICU readmission within ≤ 3 months of initial ICU discharge	Other: non interventional study; non interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU readmission within ≤ 3 months of initial ICU discharge	Incidence, causes and outcomes of ICU readmission within ≤ 3 months of initial ICU discharge	within 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
one year survival	comparison between one year survival in both groups	Within 3 months

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2019
• Primary Completion (Actual): March 15, 2021
• Study Completion (Actual): June 20, 2021

Study Registration Dates

• First Submitted: August 21, 2019
• First Submitted That Met QC Criteria: August 22, 2019
• First Posted (Actual): August 26, 2019

Study Record Updates

• Last Update Posted (Actual): February 16, 2022
• Last Update Submitted That Met QC Criteria: February 15, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: IRB//0006379

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No