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Clinical Trials/NCT05869578
NCT05869578
Not yet recruiting
Not Applicable

Registry of Patients Subjected to the Perioperative Care of the Anesthesia Service of Clinica Alemana of Santiago Chile

Clinica Alemana de Santiago1 site in 1 country10,000 target enrollmentJune 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Perioperative Complication
Sponsor
Clinica Alemana de Santiago
Enrollment
10000
Locations
1
Primary Endpoint
All-cause mortality rate in the postoperative period
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

To assess mortality and morbidity associated to anesthesia interventions

Detailed Description

Currently evidence-based medicine is one of the most important tools guiding our medical practice. Part of this evidence has been generated from clinical records, which has allowed access to large databases from which relevant information has been obtained for perioperative risk stratification, searching for complications, having specific information on procedures, among others. A clear example, especially useful daily in anesthesia work, is the NSQIP score, a tool that allows calculating perioperative risk according to the conditions of the patient and the surgery. NSQIP score is considered to make decisions in both the American and the European guidelines for preoperative evaluation for surgery. Latin-American or Chilean databases are not available at the present time. Chile lacks of population perioperative databases, methodology and practice of medicine outcomes records, thus making necessary the generation of a retrospective/prospective registry. The investigators expect that this registry will allow the collection of perioperative information appropriate to characterize the Chilean population, observe its evolution, and detect risk factors. Moreover, this registry will grant the investigators the means to design new research studies that may allow them to gather medical evidence of superior quality, thus benefiting patients with the best and safest interventions and procedures.

Registry
clinicaltrials.gov
Start Date
June 1, 2023
End Date
January 1, 2045
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Clinica Alemana de Santiago
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • All individuals
  • Individuals agreeing to participate in the study by signing a consent

Exclusion Criteria

  • The subjects who had insufficient data in their files

Outcomes

Primary Outcomes

All-cause mortality rate in the postoperative period

Time Frame: 30 days

Posoperative mortality of individuals exposed to any anesthesia related intervention or event

Number of patients who needed rehospitalization in the posoperative period

Time Frame: 7 days after primary discharge

Posoperative rehospitalization rate of individuals exposed to any anesthesia related intervention or event, after primary discharge

All-cause mortality rate in the posoperative period

Time Frame: one year

Posoperative mortality of individuals exposed to any anesthesia related intervention or event

Number of patients presenting a complication in the posoperative period

Time Frame: 30 days

Perioperative morbidity of individuals exposed to any anesthesia related intervention or event.

Number of deaths in the postoperative period after readmission

Time Frame: up to 30 days

In-hospital mortality of patients that were readmitted after primary discharge

Secondary Outcomes

  • Number of patients that develops postoperative Major Acute Cardiac Events (MACE), as defined by the American Heart Association(7 and 30 days)
  • Change from baseline in pain, as measured by the visual analog scale (VAS)(Baseline pre-intervention VAS, postoperative/intervention 1 hour VAS, postoperative/intervention 24 hour VAS)
  • Number of patients that develops postoperative acute kidney injury, as measured by Kidney Disease Improving Global Outcomes (KIDGO)-2012 serum creatinine criteria(7 and 30 days)
  • Number of patients that develop posoperative chronic pain as measured by visual analog scale(3, 6, and 12 months)

Study Sites (1)

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