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CompletedNCT04067739Updated Feb 16, 2022

ICU Readmission in Adult Egyptian Patients Undergoing Living Donor Liver Transplant

An observational study in ICU Readmission, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-16.

Sponsored by Ain Shams University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
299
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.
02

Conditions studied

  • ICU Readmission
03

In context

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Inclusion criteria

  • Adult Egyptian Patients >18 years

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
299 participants (actual)
Patient registry
No

Groups and cohorts

  • Readmission group

    Readmission is defined as ICU readmission within ≤ 3 months of initial ICU discharge

    Other: 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

Interventions

  • Othernon interventional study

    non interventional study

06

What researchers measure

Primary outcomes

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

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

    Time frame: within 3 months

Secondary outcomes

  1. one year survival

    comparison between one year survival in both groups

    Time frame: Within 3 months

07

Study locations

1 site
  • Hanaa El Gendy
    Cairo, Ain Shams University Specialized Hospital, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04067739
Lead sponsor
Ain Shams University
Responsible party
Hanaa Mohamed Abdallah ElGendy MD (Assistant Professor, Ain Shams University) — Principal investigator
First posted
Aug 26, 2019
Start date
Oct 15, 2019
Primary completion
Mar 15, 2021
Completion
Jun 20, 2021
Last update
Feb 16, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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