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ICU Readmission in Adult Egyptian Patients Undergoing Living Donor Liver Transplant

15. februar 2022 opdateret af: Hanaa Mohamed Abdallah ElGendy MD, Ain Shams University

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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

  • 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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

299

Kontakter og lokationer

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Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Tilbagevirkende kraft

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Readmission group
Readmission is defined as ICU readmission within ≤ 3 months of initial ICU discharge
Andet: ikke-interventionel undersøgelse
ikke-interventionel undersøgelse
Non readmitted group
Non readmission is defined as no need for ICU readmission within ≤ 3 months of initial ICU discharge
Andet: ikke-interventionel undersøgelse
ikke-interventionel undersøgelse

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
ICU readmission within ≤ 3 months of initial ICU discharge
Tidsramme: within 3 months
Incidence, causes and outcomes of ICU readmission within ≤ 3 months of initial ICU discharge
within 3 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
one year survival
Tidsramme: Within 3 months
comparison between one year survival in both groups
Within 3 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ain Shams University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. oktober 2019

Primær færdiggørelse (Faktiske)

15. marts 2021

Studieafslutning (Faktiske)

20. juni 2021

Datoer for studieregistrering

Først indsendt

21. august 2019

Først indsendt, der opfyldte QC-kriterier

22. august 2019

Først opslået (Faktiske)

26. august 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. februar 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. februar 2022

Sidst verificeret

1. februar 2022

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • IRB//0006379

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Kliniske forsøg med ICU Readmission

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