ICU ReadmissionNCT04067739
ICU Readmission in Adult Egyptian Patients Undergoing Living Donor Liver Transplant
An observational study of ICU Readmission, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU Readmission
- What is being tested?
- non interventional study
- How many people
- 299 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2019to 20 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Adult Egyptian Patients >18 years
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- ICU Readmission
- Being tested
- non interventional study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non interventional studyOther
non interventional study
| Study group | Role | What they receive |
|---|---|---|
| Readmission group | Readmission is defined as ICU readmission within ≤ 3 months of initial ICU discharge Receives: Other: non interventional study | |
| Non readmitted group | Non readmission is defined as no need for ICU readmission within ≤ 3 months of initial ICU discharge Receives: Other: non interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU readmission within ≤ 3 months of initial ICU discharge
Incidence, causes and outcomes of ICU readmission within ≤ 3 months of initial ICU discharge
Measured: within 3 months
Secondary outcomes (1)
one year survival
comparison between one year survival in both groups
Measured: Within 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start15 Oct 2019
- Primary completion15 Mar 2021
- Study completion20 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICU ReadmissionStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanaa Mohamed Abdallah ElGendy MD, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04067739
- Sponsor's protocol ID
- IRB//0006379
- Status last verified
- Feb 2022
- First submitted
- 21 Aug 2019
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICU Readmission in Adult Egyptian Patients Undergoing Living Donor Liver Transplant: Incidence, Causes and Outcomes: A Single Centre Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT04067739
- Acronym / sponsor ID
- IRB//0006379
- Conditions
- ICU Readmission
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 20 Jun 2021 (actual)
- First posted
- 26 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Readmission group | – | Other: non interventional studyReadmission is defined as ICU readmission within ≤ 3 months of initial ICU discharge |
| Non readmitted group | – | Other: non interventional studyNon readmission is defined as no need for ICU readmission within ≤ 3 months of initial ICU discharge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Adult Egyptian Patients >18 years
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non interventional studynon interventional study | Other | Non readmitted group, Readmission group |
Primary outcome
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
1 secondary outcome
one year survival
Time frame: Within 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ICU Readmission, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU readmission within ≤ 3 months of initial ICU discharge (time frame: within 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022.