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临床试验/NCT05869578
NCT05869578尚未招募不适用

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

Clinica Alemana de Santiago1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
10,000
试验地点
1
主要终点
All-cause mortality rate in the postoperative period

研究概览

简要总结

To assess mortality and morbidity associated to anesthesia interventions

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

  • The subjects who had insufficient data in their files

结局指标

主要结局

All-cause mortality rate in the postoperative period

时间窗: 30 days

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

Number of patients who needed rehospitalization in the posoperative period

时间窗: 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

时间窗: one year

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

Number of patients presenting a complication in the posoperative period

时间窗: 30 days

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

Number of deaths in the postoperative period after readmission

时间窗: up to 30 days

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

次要结局

  • 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)

研究者

发起方
Clinica Alemana de Santiago
申办方类型
Other
责任方
Sponsor

研究点 (1)

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