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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Egypt1 site
  • Mansoura university

    Al Mansurah, 35511

Other trials in Egypt

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

  1. Patients can't give consent (unconscious).
  2. 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.
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 groups in NCT04452682
Study groupRoleWhat they receive
Era of COVID 19Total number of cases admitted during first six months of 2020
Receives: Other: COVID 19 impact
Era of Non COVID 19Total 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.

  1. The ICU admission with associated Pneumonia

    The ICU admission caused by Pneumonia proved radio-logically at both periods

    Measured: 6 months

  2. 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)
  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.

  1. First posted30 Jun 2020
  2. Study start25 May 2020
  3. Primary completion21 Jun 2020
  4. Study completion21 Jun 2020

Resources

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)
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

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.

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