ICU Readmission in Adult Egyptian Patients Undergoing Living Donor Liver Transplant

NCT04067739 | Completed DMC

• 1 other identifier: IRB//0006379
• Study Type: observational
• Target: 299
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

ICU Readmission

Outcome Measures

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

  within 3 months

Secondary Outcomes (1)

• one year survival

  Within 3 months

Study Arms (2)

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

non interventional study OTHER

non interventional study

Non readmitted group; Readmission group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adult Egyptian Patients \>18 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Hanaa El Gendy

Cairo, Ain Shams University Specialized Hospital, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: August 26, 2019
• Study Start: October 15, 2019
• Primary Completion: March 15, 2021
• Study Completion: June 20, 2021
• Last Updated: February 16, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)