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ICU Readmission in Adult Egyptian Patients Undergoing Living Donor Liver Transplant

A

Ain Shams University

Status

Completed

Conditions

ICU Readmission

Treatments

Other: non interventional study

Study type

Observational

Funder types

Other

Identifiers

NCT04067739
IRB//0006379

Details and patient eligibility

About

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

Full 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.

Enrollment

299 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

299 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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