COVIDNCT04452682
The Impact of COVID-19 Pandemic on Critical Limb Threatening Ischemia and Emergency Vascular Practice
An observational study of COVID and Critical Limb Ischemia, run by Mansoura University at 1 site in Egypt.
Trial summary
This is a retrospective analytical study conducted at Vascular and Endovascular surgery Department, Mansoura University Hospital, including all patients admitted at the two periods first six months of 2019 and 2020.To demonstrate the effect of COVID-19 pandemic on the practice of emergency vascular surgery and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID, Critical Limb Ischemia
- What is being tested?
- COVID 19 impact
- How many people
- 998 participants
- Where
- 1 siteEgypt
- Study dates
- 25 May 2020to 21 Jun 2020
- 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 Any age
- Child, Adult, Older adult
Study population: It will include all patients presented to our department at the first 6 months of 2019 and first 6 months of 2020.
Who may be able to join
- All patients admitted to our department at that periods.
Who cannot join
- Patients can't give consent (unconscious).
- Those with mental or behavioral disorders will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
This is a retrospective analytical study conducted at Vascular and Endovascular surgery Department, Mansoura University Hospital, including all patients admitted at the two periods first six months of 2019 and 2020.To demonstrate the effect of COVID-19 pandemic on the practice of emergency vascular surgery and critical limb threatening ischemia interventions by comparison two periods first six months of 2019 and 2020.
Read the detailed description
INTRODUCTION:
The novel coronavirus pneumonia (COVID-19) pandemic has affected the globe, with Italy leading many reports of the incidence and mortalities. Recently reported studies have described the clinical characteristics and overall outcomes of patients with COVID-19 and the effects of treating these patients on the healthcare system.Two studies have reported associated coagulopathy disorders. These reports have highlighted the presence of a coexisting hypercoagulable state in patients with COVID-19, which might be associated with higher mortality.
The COVID-19 pandemic has had many impacts, both seen and unforeseen, all over the world. As expected, elective endovascular procedures have been halted, with a significant decrease in urgent/emergent procedures. This could reflect an understandable unwillingness on the part of patients who continue to self-isolate at home to come in for treatments, including those with Critical limb threatening ischemia. Also impacts on the supply chain side of performing interventions, had been reported, it is challenging to be in the middle of a complex CLTI (Critical limb threatening ischemia) case and request a routine device only to find out it is unavailable.
Aim of the work Evaluation the impact of COVID-19 pandemic on emergency vascular practice and critical limb ischemia.
Outcome
Primary outcomes:
- Frequencies of patients admitted at the Vascular.
- Predisposing Factors.
- Number of ICU admission.
Secondary outcomes:
- Mortality rates
Patients and methods Study location: The study will be conducted at the department of vascular surgery in Mansoura university hospitals Type of study: Observational analytical study Study duration: 2019-2020 Sample size: It will include all patients presented to our department at the first 6 months of 2019 and first 6 months of 2020. sample size will be 140-400 patients Inclusion criteria: all patients admitted to our department at that periods Exclusion criteria
- Patients can't give consent (unconscious).
- Those with mental or behavioral disorders will be excluded. Consent: Patients after signing informed consent that possible complication from the procedure ought to happen and what are the alternatives.
Data collection:
- All patients with complete medical records available will be documented
- Each patient's record will be analyzed to determine preexisting illnesses, admitting symptoms (including length of time to accessing medical care), admission physical findings, laboratory and results.
- Also, the type and duration of antibiotic therapy, the frequency and type of operative procedures performed and subsequent complications.
- Supporting modalities such as dialysis, blood product transfusion, and mechanical ventilation will be were reviewed.
- Each patient's premorbid medical profile, condition at admission, and subsequent treatment also will be analyzed to assess effect on mortality and development of complications.
- Standard treatment after admission including cardiovascular stabilization and assessment of extent of infection. Broad-spectrum antibiotics were administered to cover gram-positive cocci, gram-negative enteric rods, and anaerobic flora will be also reported.
- The procedure of Surgical Management will be described.
Statistical analysis
- The data will be analyzed using Statistical Package for the Social Sciences. The numerical outcomes e.g. age is calculated as median. Gender will be recorded as frequency and percentage. Chi Square test is applied to assess the association of various parameters. The results will be considered statistically significant if the p-value is found to be less than or equal to 0.05. To assess possible risk factors for mortality, univariate analyses will be completed initially to aid in determining the variables that should be included in a stepwise logistic regression model.
- Conditions
- COVID, Critical Limb Ischemia
- Being tested
- COVID 19 impact
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID 19 impactOther
The impact of COVID-19 pandemic on Critical limb threatening ischemia and emergency vascular practice
| Study group | Role | What they receive |
|---|---|---|
| Era of COVID 19 | Total number of cases admitted during first six months of 2020 Receives: Other: COVID 19 impact | |
| Era of Non COVID 19 | Total number of cases admitted the first six months of 2019 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ICU admission with associated Pneumonia
The ICU admission caused by Pneumonia proved radio-logically at both periods
Measured: 6 months
Impact of COVID-19 on the different presentation of vascular surgery at the emergency
percentage of different diagnoses at both periods
Measured: 6 months
Secondary outcomes (1)
Mortality rates
Mortality percentages at both periods
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start25 May 2020
- Primary completion21 Jun 2020
- Study completion21 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 998 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04452682
- Sponsor's protocol ID
- R.20.06.898 - 2020/06/16
- Status last verified
- Jun 2020
- First submitted
- 21 Jun 2020
- Last updated
- 30 Jun 2020
- 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 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of COVID-19 Pandemic on Critical Limb Threatening Ischemia and Emergency Vascular Practice
- ClinicalTrials.gov ID
- NCT04452682
- Acronym / sponsor ID
- R.20.06.898 - 2020/06/16
- Conditions
- COVID, Critical Limb Ischemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 998 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 25 May 2020 (actual)
- Primary completion
- 21 Jun 2020 (actual)
- Study completion
- 21 Jun 2020 (actual)
- First posted
- 30 Jun 2020 (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.
This is a retrospective analytical study conducted at Vascular and Endovascular surgery Department, Mansoura University Hospital, including all patients admitted at the two periods first six months of 2019 and 2020.To demonstrate the effect of COVID-19 pandemic on the practice of emergency vascular surgery and critical limb threatening ischemia interventions by comparison two periods first six months of 2019 and 2020.
Detailed description
INTRODUCTION:
The novel coronavirus pneumonia (COVID-19) pandemic has affected the globe, with Italy leading many reports of the incidence and mortalities. Recently reported studies have described the clinical characteristics and overall outcomes of patients with COVID-19 and the effects of treating these patients on the healthcare system.Two studies have reported associated coagulopathy disorders. These reports have highlighted the presence of a coexisting hypercoagulable state in patients with COVID-19, which might be associated with higher mortality.
The COVID-19 pandemic has had many impacts, both seen and unforeseen, all over the world. As expected, elective endovascular procedures have been halted, with a significant decrease in urgent/emergent procedures. This could reflect an understandable unwillingness on the part of patients who continue to self-isolate at home to come in for treatments, including those with Critical limb threatening ischemia. Also impacts on the supply chain side of performing interventions, had been reported, it is challenging to be in the middle of a complex CLTI (Critical limb threatening ischemia) case and request a routine device only to find out it is unavailable.
Aim of the work Evaluation the impact of COVID-19 pandemic on emergency vascular practice and critical limb ischemia.
Outcome
Primary outcomes:
- Frequencies of patients admitted at the Vascular.
- Predisposing Factors.
- Number of ICU admission.
Secondary outcomes:
- Mortality rates
Patients and methods Study location: The study will be conducted at the department of vascular surgery in Mansoura university hospitals Type of study: Observational analytical study Study duration: 2019-2020 Sample size: It will include all patients presented to our department at the first 6 months of 2019 and first 6 months of 2020. sample size will be 140-400 patients Inclusion criteria: all patients admitted to our department at that periods Exclusion criteria
- Patients can't give consent (unconscious).
- Those with mental or behavioral disorders will be excluded. Consent: Patients after signing informed consent that possible complication from the procedure ought to happen and what are the alternatives.
Data collection:
- All patients with complete medical records available will be documented
- Each patient's record will be analyzed to determine preexisting illnesses, admitting symptoms (including length of time to accessing medical care), admission physical findings, laboratory and results.
- Also, the type and duration of antibiotic therapy, the frequency and type of operative procedures performed and subsequent complications.
- Supporting modalities such as dialysis, blood product transfusion, and mechanical ventilation will be were reviewed.
- Each patient's premorbid medical profile, condition at admission, and subsequent treatment also will be analyzed to assess effect on mortality and development of complications.
- Standard treatment after admission including cardiovascular stabilization and assessment of extent of infection. Broad-spectrum antibiotics were administered to cover gram-positive cocci, gram-negative enteric rods, and anaerobic flora will be also reported.
- The procedure of Surgical Management will be described.
Statistical analysis
- The data will be analyzed using Statistical Package for the Social Sciences. The numerical outcomes e.g. age is calculated as median. Gender will be recorded as frequency and percentage. Chi Square test is applied to assess the association of various parameters. The results will be considered statistically significant if the p-value is found to be less than or equal to 0.05. To assess possible risk factors for mortality, univariate analyses will be completed initially to aid in determining the variables that should be included in a stepwise logistic regression model.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Era of COVID 19 | – | Other: COVID 19 impactTotal number of cases admitted during first six months of 2020 |
| Era of Non COVID 19 | – | –Total number of cases admitted the first six months of 2019 |
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- It will include all patients presented to our department at the first 6 months of 2019 and first 6 months of 2020.
Key inclusion criteria (1 listed)
- All patients admitted to our department at that periods.
Key exclusion criteria (2 listed)
- Patients can't give consent (unconscious).
- Those with mental or behavioral disorders will be excluded.
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 |
|---|---|---|
| COVID 19 impactThe impact of COVID-19 pandemic on Critical limb threatening ischemia and emergency vascular practice | Other | Era of COVID 19 |
Primary outcome
The ICU admission with associated Pneumonia
Time frame: 6 months
The ICU admission caused by Pneumonia proved radio-logically at both periods
Impact of COVID-19 on the different presentation of vascular surgery at the emergency
Time frame: 6 months
percentage of different diagnoses at both periods
1 secondary outcome
Mortality rates
Time frame: 6 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 30 Jun 2020.
- 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 COVID and Critical Limb Ischemia, run by Mansoura 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 2 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 30 Jun 2020. 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?
The ICU admission with associated Pneumonia (time frame: 6 months). The study lists 2 primary outcomes in all. 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 30 Jun 2020; AzTrials last refreshed its copy on 8 Nov 2026.