Adverse Events in Acute Limb Ischemic Patient Undergoing Revascularization

Major Adverse Cardiac Events Clinical Trial

Official title:

Incidence and Risk Factors of in Hospital Adverse Events in Acute Limb Ischemic Patient Undergoing Revascularization Treatment: a Retrospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05362266
• Other study ID #: 052/2565
• Status: Recruiting
• Start date: April 10, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: May 2022
• Source: Mahidol University
• Contact: Tachawan Jirativanont, MD
• Phone: +66816422817
• Email: tachawan.jir[@]mahidol.acth
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Acute limb ischemia is one of the devastating vascular emergencies that lead to life and limb loss if the appropriate treatment is not reached.The revascularization is a cornerstone in treating acute limb ischemia. The conventional surgical approach includes surgical embolectomy and surgical bypass.From the anesthetic aspect, this emergency condition limits the lengthening cardiovascular assessment of this high-risk patient group which might lead to the uncertainty outcome.With the variety of patients and procedures, we sought to find out the perioperative adverse events, especially major adverse cardiac events, in acute ischemic limb patients undergoing revascularization, in order to increase awareness of the team and properly admit to ICU in a retrospective manner.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: April 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• age more than 18 years
• undergoing revascularization surgery or procedure (surgical revascularization, endovascular revascularization, hybrid revascularization, catheter directed thrombolysis)

Exclusion Criteria:

• incomplete data during perioperative period

Related Conditions & MeSH terms

• Adverse Effect of Unspecified General Anesthetic
• Major Adverse Cardiac Events

Locations

Country	Name	City	State
Thailand	Anesthesiology department, Siriraj Hospital, Mahidol University	Bangkok
Thailand	MahidolU	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of major adverse cardiac events	Incidence of major adverse cardiac events, which are cardiovascular death, myocardial infarction, stroke	during hospital stay, up to 4 weeks
Secondary	Incidence of the perioperative complication	Incidence of the perioperative other complication, which are major bleeding, repercussion syndrome, compartment syndrome, rhabdomyolysis and unplanned ICU admission from any causes.	during hospital stay, up to 4 weeks
Secondary	Factors contribute to the adverse outcome	Factors contribute to the adverse outcome, which are the patients' condition and the underlying diseases, the surgical intervention and the anesthetic technique.	during hospital stay, up to 4 weeks