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Completed

NCT Number: NCT04067739

ICU Readmission in Adult Egyptian Patients Undergoing Living Donor Liver Transplant

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hanaa El Gendy

Cairo, Ain Shams University Specialized Hospital, Egypt

About this study

  • 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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non interventional study

Other

non interventional study

Primary outcomes

  1. ICU readmission within ≤ 3 months of initial ICU discharge

    Time frame: within 3 months

    Incidence, causes and outcomes of ICU readmission within ≤ 3 months of initial ICU discharge

Secondary outcomes

  1. one year survival

    Time frame: Within 3 months

    comparison between one year survival in both groups

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 26, 2019
Registry last updated
Feb 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.