Clinica Alemana de Santiago
Santiago, Santiago Metropolitan, 7591538, Chile
Location contact
Javiera A Vargas, MD
PRINCIPAL_INVESTIGATOR
Patricio A Leyton, MD
CONTACT
+562222101111 ext. 1699
Patricio A Leyton, MD
SUB_INVESTIGATOR
NCT Number: NCT05869578
To assess mortality and morbidity associated to anesthesia interventions
Trial opening soon.
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Observational
Santiago, Santiago Metropolitan, 7591538, Chile
Javiera A Vargas, MD
PRINCIPAL_INVESTIGATOR
Patricio A Leyton, MD
CONTACT
+562222101111 ext. 1699
Patricio A Leyton, MD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients exposed to any anesthesia intervention will be assessed to whether the exposure to anesthesia confers a risk for perioperative outcomes
Time frame: 30 days
Posoperative mortality of individuals exposed to any anesthesia related intervention or event
Time frame: one year
Posoperative mortality of individuals exposed to any anesthesia related intervention or event
Time frame: 30 days
Perioperative morbidity of individuals exposed to any anesthesia related intervention or event.
Time frame: 7 days after primary discharge
Posoperative rehospitalization rate of individuals exposed to any anesthesia related intervention or event, after primary discharge
Time frame: up to 30 days
In-hospital mortality of patients that were readmitted after primary discharge
Time frame: Baseline pre-intervention VAS, postoperative/intervention 1 hour VAS, postoperative/intervention 24 hour VAS
Scores are measured on a 10-point VAS. The VAS ranges from 0 to 10 with 0 indicating no pain, and higher scores indicating greater pain.
Time frame: 7 and 30 days
Criteria for developing acute kidney injury are:
Increase in serum creatinin by ≽0.3 mg/dl (≽26.5lmol/l) within 48hours; or Increase in serum creatinine ≽1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or Urine volume < 0.5ml/kg/h for 6hours.
Time frame: 7 and 30 days
Criteria for MACE are the development of any of the following conditions Non-fatal stroke Non-fatal myocardial infarction Cardiovascular death
Time frame: 3, 6, and 12 months
Scores are measured on a 10-point VAS. The VAS ranges from 0 to 10 with 0 indicating no pain, and higher scores indicating greater pain.
Contact information is provided by the study sponsor or research team.
Javiera A Vargas, MD
CONTACT
+56222101111 ext. 1699
Patricio A Leyton, MD
CONTACT
+5622101111 ext. 1699
Clinica Alemana de Santiago
Other
Registry of Patients Subjected to the Perioperative Care of the Anesthesia Service of Clinica Alemana of Santiago Chile
Acronym: RAMP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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