Complication of AnesthesiaNCT03862664
Respiratory Complications Among Living Liver-donors
An observational study of Complication of Anesthesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
Recently, there are increasing reports about pulmonary complications within living liver donors postoperatively. In this retrospective study, the investigators will highlight the risk factors and incidence of pulmonary complication among living liver-donors in our center. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Complication of Anesthesia
- What is being tested?
- Collection of data
- Type of treatment
- Surgery or procedure
- How many people
- 124 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Feb 2019to May 2019
- 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 20 to 50 years
- All sexes
- Adult
Study population: Donors who underwent hepatic lobectomy for liver transplantation
Who may be able to join
- Excellent general physical and mental condition,
- Free of chronic disease or
- Previous major abdominal surgery,
- Body mass index (BMI) <28,
- ABO blood group identical to recipients and
- Negative for hepatitis B, C and human immunodeficiency viruses (HIV).
Who cannot join
- ASA physical status> II,
- BMI>28,
- Psychiatric or mental retardation,
- pregnant and nursing women or
- Patients with significant laboratory abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Respiratory Complications Among Living Liver-donors: a Single Center Observational Retrospective Study
Recently, there are increasing reports about pulmonary complications within living liver donors postoperatively. In this retrospective study, the investigators will highlight the risk factors and incidence of pulmonary complication among living liver-donors in our center.
- Conditions
- Complication of Anesthesia
- Being tested
- Collection of data
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of dataProcedure or surgery
The investigators will retrieve retrospectively the medical record of donors who underwent hepatic lobectomy for liver transplantation
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants with postoperative respiratory complications
Respiratory complications as pulmonary embolism, pleural effusion, pneumothorax, pneumonia, atelectasis, acute lung injury (ALI), acute respiratory distress syndrome (ARDS), and transfusion-related acute lung injury (TRALI) will be considered when they are clinically evident.
Measured: an average period of 3 year
Secondary outcomes (2)
The average of ICU stay among patients
It is defined as time period from entry to ICU till discharge to the ward
Measured: an average period of 3 year
The average of hospital stay among patients
It is defined as time period elapsed from discharge to the ward till leaving the hospital
Measured: an average period of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start6 Feb 2019
- Primary completionApr 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of AnesthesiaStudies 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
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Sayed Shorbagy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03862664
- Sponsor's protocol ID
- FAMSU R37/2018
- Status last verified
- Feb 2019
- First submitted
- 25 Feb 2019
- Last updated
- 5 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Complications Among Living Liver-donors: a Single Center Observational Retrospective Study
- ClinicalTrials.gov ID
- NCT03862664
- Acronym / sponsor ID
- FAMSU R37/2018
- Conditions
- Complication of Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 6 Feb 2019 (actual)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 5 Mar 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.
Recently, there are increasing reports about pulmonary complications within living liver donors postoperatively. In this retrospective study, the investigators will highlight the risk factors and incidence of pulmonary complication among living liver-donors in our center.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- Donors who underwent hepatic lobectomy for liver transplantation
Key inclusion criteria (6 listed)
- Excellent general physical and mental condition,
- Free of chronic disease or
- Previous major abdominal surgery,
- Body mass index (BMI) <28,
- ABO blood group identical to recipients and
Key exclusion criteria (5 listed)
- ASA physical status> II,
- BMI>28,
- Psychiatric or mental retardation,
- pregnant and nursing women or
- Patients with significant laboratory abnormalities
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 |
|---|---|---|
| Collection of dataThe investigators will retrieve retrospectively the medical record of donors who underwent hepatic lobectomy for liver transplantation | Procedure or surgery | – |
Primary outcome
The number of participants with postoperative respiratory complications
Time frame: an average period of 3 year
Respiratory complications as pulmonary embolism, pleural effusion, pneumothorax, pneumonia, atelectasis, acute lung injury (ALI), acute respiratory distress syndrome (ARDS), and transfusion-related acute lung injury (TRALI) will be considered when they are clinically evident.
2 secondary outcomes
The average of ICU stay among patients
Time frame: an average period of 3 year
The average of hospital stay among patients
Time frame: an average period of 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Individual participant dataSharing planned: Undecided
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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 Complication of Anesthesia, 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 5 Mar 2019. 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?
Results are not available in the source record.
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?
The number of participants with postoperative respiratory complications (time frame: an average period of 3 year). 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 5 Mar 2019.