Adverse Events in Acute Limb Ischemic Patient Undergoing Revascularization

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

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.

Study Overview

• Status: Recruiting
• Conditions: Major Adverse Cardiac Events; Adverse Effect of Unspecified General Anesthetic

• Study Type: Observational
• Enrollment (Anticipated): 240

Contacts and Locations

• Study Contact: Name: Tachawan Jirativanont, MD; Phone Number: +66816422817; Email: tachawan.jir@mahidol.acth

Study Locations

• Thailand
  • Bangkok, Thailand
    • Recruiting
    • Anesthesiology department, Siriraj hospital, Mahidol University
    • Contact: Siriluk Suksri; Phone Number: +6624197990
    • Principal Investigator: Tachawan Jirativanont, MD
  • Bangkok, Thailand
    • Recruiting
    • MahidolU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Age more than 18, with acute limb ischemia undergoing revascularization procedure

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Mahidol University

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2022
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: April 11, 2022
• First Submitted That Met QC Criteria: May 3, 2022
• First Posted (Actual): May 5, 2022

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 052/2565

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The data has no plan for sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No