Respiratory Complications Among Living Liver-donors

March 1, 2019 updated by: Mohammed Sayed Shorbagy, Ain Shams University

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.

Study Overview

Status

Unknown

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

124

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cairo, Egypt, 11591
        • Ain Shams university hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Donors who underwent hepatic lobectomy for liver transplantation

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • ASA physical status> II,
  • BMI>28,
  • Psychiatric or mental retardation,
  • pregnant and nursing women or
  • Patients with significant laboratory abnormalities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
an average period of 3 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The average of ICU stay among patients
Time Frame: an average period of 3 year
It is defined as time period from entry to ICU till discharge to the ward
an average period of 3 year
The average of hospital stay among patients
Time Frame: an average period of 3 year
It is defined as time period elapsed from discharge to the ward till leaving the hospital
an average period of 3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2019

Primary Completion (Anticipated)

April 1, 2019

Study Completion (Anticipated)

May 1, 2019

Study Registration Dates

First Submitted

February 25, 2019

First Submitted That Met QC Criteria

March 1, 2019

First Posted (Actual)

March 5, 2019

Study Record Updates

Last Update Posted (Actual)

March 5, 2019

Last Update Submitted That Met QC Criteria

March 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • FAMSU R37/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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